Day: March 15, 2022

• ENA Respiratory begins influenza challenge study for fast-acting nasal spray INNA-051, designed to boost innate immunity in patients at high risk of severe complications from respiratory infections

SYDNEY, Australia, March 15, 2022 (GLOBE NEWSWIRE) —  ENA Respiratory, a clinical-stage pharmaceutical company developing INNA-051, a first-in-class broad-spectrum antiviral innate immunomodulator for pre- and post-exposure prophylaxis of respiratory viral infections in populations at risk of complications, has dosed its first participants in a Phase 2a flu-challenge study.

The Phase 2a trial is a single centre, prospective, randomised, double-blind, placebo-controlled study exploring two dose levels of INNA-051 administered as an intranasal spray to healthy adults to evaluate the safety, tolerability, and antiviral efficacy of INNA-051 against H3N2 influenza virus infection. The study will enroll up to 123 participants. Efficacy is being assessed as the reduction of total viral load by RT-qPCR and total symptoms score in treated versus placebo participants.

This human influenza challenge pre-exposure prophylaxis study supports the development of INNA-051 for pan-antiviral use in those at high-risk of complications from SARS-CoV-2, rhinovirus, RSV, influenza, and other common respiratory viruses. It is being conducted in the United Kingdom, with results expected by the end of the year.

“Patients at high-risk of complications from a respiratory viral infection, such as the elderly and those with pre-existing lung, cardiovascular, liver and kidney chronic diseases, urgently need therapies that help the body respond faster and reduce the risk of hospitalization or complications. This study will take us another step closer to determining whether INNA-051 can provide a fast-acting, easy-to-use therapy to address this unmet need,” said Christophe Demaison, Ph.D., co-founder and CEO of ENA Respiratory.

A Phase 2 COVID-19 post-exposure antiviral prophylaxis study to determine whether INNA-051 reduces the incidence and severity of symptomatic COVID-19 is also expected to begin shortly. The study also will evaluate whether the nasal spray reduces the magnitude and duration of SARS-CoV-2 nasal shedding, to understand potential broader public health benefits. INNA-051 was found to be well-tolerated in a Phase 1 study, and complete Phase 1 results are expected soon.

Notes to Editors

If you would like to arrange an interview, please contact:

• Glenn Silver, Finn Partners, +1 973 818 8198, glenn.silver@finnpartners.com

About ENA Respiratory and INNA-051

ENA Respiratory is aiming to transform the prevention of respiratory viral infections in populations at-risk of complications. The company is based in Melbourne and Sydney, Australia and it has secured a Series A investment from Brandon Capital Partners’ managed funds, the Minderoo Foundation, and Uniseed.

INNA-051 is a potent innate immune TLR2/6 agonist. It is being developed for intranasal delivery to target the primary entry site of viral respiratory infections as most respiratory viruses, including SARS-CoV-2 and influenza, initially infect and replicate in nasal mucosa epithelial cells. Fast-acting and inducing a durable biologic response supporting weekly administration, INNA-051 works by recruiting innate immune cells and priming epithelial cells of the nasal mucosa to respond more quickly to infections, rapidly eliminating viruses and other pathogens before they spread throughout the body. INNA-051 and close analogues have been shown in preclinical studies to be effective against multiple respiratory viruses, including SARS-CoV-2, influenza (H1N1 and seasonal H3N2), and rhinovirus.

Key features of INNA-051 intranasal administration include limited minimal or no systemic bioavailability, minimal or no systemic pro-inflammatory cytokine release, no direct type I interferon upregulation which is known to be associated with fever in humans, durable immune response supporting weekly administration, and compatibility with vaccine and intranasal corticosteroids.

For more information, please visit https://enarespiratory.com

ITA Airways announces that it has signed a preliminary agreement with the maintenance company Atitech, for a service contract

In relation to the tender for the acquisition of the maintenance business unit of Alitalia under Extraordinary Administration expiring today, 14 March 2022, ITA Airways announces that it has signed a preliminary agreement with the maintenance company Atitech, for a service contract. If the tender is awarded to Atitech, this preliminary agreement will be consolidated, in compliance with ITA Airways’ governance processes, into a long-term service contract that identifies services and fares related to the activities indicated in the tender.

ROME, March 15, 2022 (GLOBE NEWSWIRE) — In relation to the tender for the acquisition of the maintenance business unit of Alitalia under Extraordinary Administration expiring today, 14 March 2022, ITA Airways announces that it has signed a preliminary agreement with the maintenance company Atitech, for a service contract.

If the tender is awarded to Atitech, this preliminary agreement will be consolidated, in compliance with ITA Airways’ governance processes, into a long-term service contract that identifies services and fares related to the activities indicated in the tender.

The agreement is based on the general terms and conditions of the Standard Agreement (published by IATA – 2013 and 2018 Editions), with all exceptions, derogations and special conditions indicated in the applicable EU regulations.

In the event that Atitech should not be awarded the tender issued by Alitalia under Extraordinary Administration, this preliminary agreement will be terminated. In this case, ITA Airways underlines that, based on its interest in the maintenance business unit of Alitalia in Extraordinary Administration and respecting the professionalism of its workforce, it will continue to operate under the maintenance service contract already signed with Alitalia under Extraordinary Administration until its natural expiry in October, pursuing the best results in economic and service terms and in full compliance with the applicable regulatory framework.

For more information:
LaPresse SpA Communication and Press Office Director
Barbara Sanicola – barbara.sanicola@lapresse.it 
+39 02 26305578 M +39 333 3905243

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b4031ff3-c686-4ba5-9a52-05881ee7b820

The photo is also available at Newscom, www.newscom.com, and via AP PhotoExpress.

Mexico has adopted the Codex international food safety authority’s specification for steviol glycosides

Rancho Santa Margarita, Calif., March 15, 2022 (GLOBE NEWSWIRE) — Sweegen’s entire Signature Bestevia® portfolio of nature-based sweeteners and sweetener systems is now accessible to brands in Mexico after the country’s food safety authority adopted the Codex Alimentarius (Codex) specifications for steviol glycosides produced by different technologies. This includes Sweegen’s bioconversion method for producing clean and non-GMO stevia sweeteners, such as Rebaudiosides B, D, E, I, M, and N. Codex is the international food safety organization under the auspices of the World Health Organization (WHO).

“Mexico’s Codex adoption is a step in the right direction for tackling obesity and diabetes in adults and children stemming from high sugar in products,” said Luca Giannone, senior vice president of global sales. “Streamlining the regulatory process for introducing new generation zero-calorie stevia sweeteners contributes to the improvement of overall health and wellness for consumers.”

Giannone further said, “We are eager to share with brands in Mexico our expertise and high-quality ingredients for creating great-tasting, better-for-you product innovations.” He said, “Our robust portfolio of Signature sweeteners and sweetener systems featuring our proprietary Bestevia products is unparalleled; it demonstrates our commitment to investing in new technologies for offering the very best natural sweeteners to brands for tackling the challenges of sugar reduction and replacement in the formulation of food and beverages.”

Adopting the rigorous Codex framework for stevia technologies provided a streamlined approach for reviewing and approving Sweegen’s clean and sustainable bioconversion process. This approval by Mexico will provide greater access to less common and better-tasting steviol glycosides at scale and a more sustainable supply of zero-calorie ingredients with a taste closest to sugar.

Before the adoption, Sweegen’s Rebaudiosides M and D were approved in Mexico through the standard regulatory process. The new regulatory development opens doors for Sweegen to introduce unique Signature sweetener systems to brands, in addition to its Rebs D and M, further expanding product developers’ sugar reduction toolkits.

“With more sugar reduction tools for brands to explore, they can rapidly develop great-tasting and healthy food and beverages, sparking and inspiring new innovations and product launches,” said Giannone.

Sweegen’s LATAM Innovation Studio is located in Mexico City and serves the entire region. It is one of many global creative centers home to product developers exploring sweet taste solutions, local consumer insights, and collaborating on new or reformulated products with Sweegen’s expert food and applications team.

“The Codex framework sets a good regulatory example on welcoming better ingredients for supporting health and wellness,” said Hadi Omrani, senior director of technical and regulatory affairs. “As more countries follow suit, Sweegen’s global stevia footprint will rapidly expand into more countries, providing brands better options in sugar reduction solutions where they are under government pressure, like Mexico, to produce healthy food and beverages.”

Obesity, diabetes, and associated diseases are prevalent in Mexico and are leading public health concerns. Adult obesity increased by 42.2% from 2000 to 2018. Childhood obesity is linked to high sugar consumption and saturated fats. In 2016, Mexico declared an epidemiological alert as a result of high rates of diabetes and obesity after a WHO report published in 2015 raised awareness on serious health issues and supported Mexico’s sugar tax on all nonalcoholic beverages with added sugar in 2014. UNICEF reports that Mexico is the largest consumer of ultra-processed products, including sugary drinks, in Latin American countries.

Mexico’s beverage sugar tax resulted in fewer people buying sodas, with an overall decline of just 7.6%. “Behavioral conditioning through a beverage tax only goes so far,” said Giannone. “Introducing better ingredients into the food and beverage space can breathe new life into product offerings and stimulate new trends, such as plant-based products or functional beverages.”

In 2020, food and beverage producers in Mexico felt more pressure by a government mandate to present new front-of-package labels warning consumers of excess calories, sugar, sodium, saturated fats, and trans-fats, as well as caffeine and artificial sweeteners.

With the Codex adoption, brands have new opportunities to connect with consumers by delivering a full sugar-like taste in food and beverages without the calories. This would be a significant advancement from several years ago when the first generation of stevia was introduced.

Unlike first-generation stevia sweeteners like Rebaudioside A, new generation rebaudiosides made by bioconversion produce clean new generation sweetener molecules like Rebaudiosides B, D, E, I, M, and N, which are originally found in small quantities in the stevia leaf. They impart a clean sugar-like taste with a better sensory profile and are highly sought-after by food and beverage manufacturers in countries with regulatory approvals.

“Brands in Mexico can look to Sweegen as a resource of expertise and as a committed partner for creating zero to low-calorie new product innovations that will delight consumers while supporting the country’s journey on health and wellness goals,” said Steven Chen, Sweegen’s chief executive officer. “We commend the food and safety authorities in Mexico for demonstrating leadership by taking action on adopting the Codex specification.”

About Sweegen

Sweegen provides sweet taste solutions for food and beverage manufacturers around the world.

We are on a mission to reduce the sugar and artificial sweeteners in our global diet.  Partnering with customers, we create delicious zero-sugar products that consumers love.  With the best next-generation stevia sweeteners in our portfolio, such as Bestevia® Rebs B, D, E, I, M, and N, along with our deep knowledge of flavor modulators and texturants, Sweegen delivers market-leading solutions that customers want and consumers prefer. Be well. Choose well.

For more information, please contact info@sweegen.com and visit Sweegen’s website, www.sweegen.com.

Cautionary Statement Concerning Forward-Looking Statements

This press release contains forward-looking statements, including, among other statements, statements regarding the future prospects for Reb M stevia leaf sweetener. These statements are based on current expectations but are subject to certain risks and uncertainties, many of which are difficult to predict and are beyond the control of Sweegen, Inc.

Relevant risks and uncertainties include those referenced in the historic filings of Sweegen, Inc. with the Securities and Exchange Commission. These risks and uncertainties could cause actual results to differ materially from those expressed in or implied by the forward-looking statements, and, therefore, should be carefully considered. Sweegen, Inc. assumes no obligation to update any forward-looking statements due to new information or future events or developments.

Attachments

• Chilled Mango Chili Beverage
• Grocery store aisle in Oaxaca Mexico 

Ana Arakelian
Sweegen
949.709.0583
ana.arakelian@sweegen.com

Sustainable hot melt adhesives resolve manufacturers from traditional hurdles in bonding

Bedford, Mass., March 15, 2022 (GLOBE NEWSWIRE) — A new era for adhesives has arrived for manufacturers seeking debondable structural adhesive solutions to avoid waste and save costs in manufacturing. Today, Conagen, the biotechnology innovator, announced the development of highly sought-after debondable hot melt adhesives made by high-performance materials from sustainable and natural bio-molecules.

“Conagen has solved the challenges manufacturers face in seeking strong structural adhesives that are long-lasting, perform strongly, and have the valuable option for breaking the adhesion before final finishing operations to deliver perfect products,” said J. McNamara, vice-president of chemical applications.

The advantages of high-strength debondable adhesives benefit multiple industries. For example, smartphones and electronics can be repaired effortlessly, and deconstructed at the end of their life without damaging components for recovery and recycling of valuable parts currently in land refills.

“Conagen’s patented debondable hot melt adhesive are incredibly stronger than what is used in the market now and can outperform petroleum-based products with a sustainable advantage that saves time, cost and reduces waste,” said McNamara.

McNamara further states, “The unexpected boost in performance comes from Conagen’s fermented ingredients already at full industrial scale.” And, “Conagen is open to discussing commercialization opportunities with manufacturers who are interested in a new era of performance materials.”

Adhesives offer many advantages in joining materials, including the ease of use compared to welding, sealing, distributing stress, and environmental resistance. Currently, manufacturers glue two pieces together and wait for a day to cure the bond. If there are imperfections in the bond, the glued products are thrown away because they cannot be unglued, resulting in time and material waste.

Today, most reactive hot melt adhesives rely on post-curing chemistry to develop adhesive strength. A downside to this approach is the curing process is irreversible and, as such, hinders or prevents de-bonding almost entirely.

While the ingredients of Conagen’s hot melt adhesives are commonly found in nature, to develop sustainable debondable adhesives, Conagen leverages its precision fermentation technology to engineer a synthetic pathway independent of plant source materials, creating more efficient and sustainable bio-based ingredients than what can be achieved with chemically-synthesized versions.

Conagen’s inspiration is self-healing materials, using sustainable and natural ingredients, turning them into high-strength debondable hot melt adhesives. “The process is as simple as cutting the plastic that reheals itself in less time than the conventional way,” said McNamara.

The Conagen adhesive is unique as it is a cross-linked material designed with reversibility in mind that exhibits the strength of traditionally cured adhesives with the added benefit of transitioning to a flowable material after heating.

Conagen’s debondable adhesive formulation is ideal for cars, boats, planes, transportation, consumer electronics and appliances, and military and industrial applications. And Adhesives in electric vehicles (EVs) are more widespread than conventional automobiles.

The adhesives market stood at $729.11 billion in 2019 and is projected to exhibit a CAGR of 5.3% between 2020 and 2027, making Conagen’s adhesive formulation lucrative in the original equipment manufacturers (OEM) market.

Conagen’s hallmark in the specialty and industrial space is discovering applications from the platform of natural bio-compounds and bio-materials for a new era of materials that are both high-performing and sustainable.

“Our adhesive formulation continues to show promise for bonding a wide array of materials, such as metal, plastic, and glass,” said McNamara. “We’re making it easier for companies to adopt a more natural position in manufacturing while staying true to the performance of their products.”

About Conagen

Conagen is a product-focused, synthetic biology R&D company with large-scale manufacturing service capabilities. Our scientists and engineers use the latest synthetic biology tools to develop high-quality, sustainable, nature-based products by precision fermentation and enzymatic bioconversion. We focus on the bioproduction of high-value ingredients for food, nutrition, flavors and fragrances, pharmaceutical, and renewable materials industries. www.conagen.com

Attachments

• Robotic hot melt adhesive
• Conagen develops sustainable debondable hot melt adhesive from natural ingredients.

Ana Arakelian
Conagen
+1.781.271.1588
ana.arakelian@conagen.com

Grid-eMotion™ Fleet smart charging solution to help the City of Berlin reach its goal of a zero-emission bus fleet by 2030

Zurich, Switzerland, March 15, 2022 (GLOBE NEWSWIRE) — Hitachi Energy has won an order from Berliner Verkehrsbe-triebe (BVG), Germany’s biggest municipal public transportation company, to supply its Grid-eMotion™ Fleet smart charging infrastructure to help BVG transition to sustainable mobility in Berlin, the country’s capital.

Hitachi Energy will provide a complete Grid-eMotion Fleet grid-to-plug charging infrastructure solution for the next two bus depots to be converted in the bus electrification program. Hitachi Energy’s solution offers the smallest footprint for both the connection, as well as low noise emissions and high reliability – three key requirements for bus depots in a densely populated urban environment, where space is limited and flawless charging is vital to ensure buses run on time.

The solution comprises a connection to the distribution grid, power distribution and DC charging infrastructure with charging points and smart charging systems. Hitachi Energy will perform the engineering and integrate, install and service the entire solution. The solution has a compact and robust design that requires less equipment than competing infrastructure, which results in a small footprint, lower operating and maintenance costs, and higher reliability. Typically, Grid-eMotion Fleet requires 60 percent less space and 40 percent less cabling than alternative charging systems; it also provides superior overall system reliability.

“We are delighted to help the City of Berlin in its transition to quiet and emission-free transportation and a sustainable energy future for the people of this iconic capital,” said Niklas Persson, Managing Director of Hitachi Energy’s Grid Integration business. “We feel the urgency and have the pioneering technology and commitment to advance sustainable mobility, thus improving the quality of life of millions of people.”

BVG operates Germany’s biggest city bus fleet of around 1,500 vehicles, which it aims to make completely electric and emission-free by 2030. This requires the installation of charging infra-structure in its large network of bus depots.

About Grid-eMotion

Grid-eMotion comprises two unique, innovative solutions – Fleet and Flash. Grid-eMotion Fleet is a grid-code compliant and space-saving grid-to-plug charging solution that can be in-stalled in new and existing bus depots. The charging solution can be scaled flexibly as the fleet gets bigger and greener. It includes a robust and compact grid connection and charging points, and is also available for commercial vehicle fleets, including last-mile delivery and heavy-duty trucks that require high power charging of several megawatts. Grid-eMotion Flash™ enables operators to flash-charge buses within seconds at passenger stops and fully recharge within minutes at the route terminus, without interrupting the bus schedule.

Both solutions are equipped with configurable smart charging digital platforms that can be em-bedded with larger fleet and energy management systems. Additional offerings from Hitachi Energy for EV charging systems consist of e-mesh™ energy management and optimization solutions and Lumada APM, EAM and FSM solutions, to help transportation operators make informed decisions that maximize their uptime and improve efficiency.

In the past few months alone, Hitachi Energy has won orders from customers and partners all over the world for its smart charging portfolio – a sign that Grid-eMotion is changing the e-mobility landscape for electric buses and commercial vehicles. Grid-eMotion solutions are al-ready operating or under development in Australia, Canada, China, India, the Middle East, the United States and several countries in Europe.

About Hitachi Energy Ltd.

Hitachi Energy is a global technology leader that is advancing a sustainable energy future for all. We serve customers in the utility, industry and infrastructure sectors with innovative solutions and services across the value chain. Together with customers and partners, we pioneer technologies and enable the digital transformation required to accelerate the energy transition towards a carbon-neutral future. We are advancing the world’s energy system to become more sustainable, flexible and secure whilst balancing social, environmental and economic value. Hitachi Energy has a proven track record and unparalleled installed base in more than 140 countries. Headquartered in Switzerland, we employ around 38,000 people in 90 countries and generate business volumes of approximately $10 billion USD.

About Hitachi, Ltd.

Hitachi, Ltd. (TSE: 6501), headquartered in Tokyo, Japan, contributes to a sustainable society with a higher quality of life by driving innovation through data and technology as the Social Innovation Business. Hitachi is focused on strengthening its contribution to the Environment, the Resilience of business and social infrastructure as well as comprehensive programs to enhance Security & Safety. Hitachi resolves the issues faced by customers and society across six domains: IT, Energy, Mobility, Industry, Smart Life and Automotive Systems through its proprietary Lumada solutions. The company’s consolidated revenues for fiscal year 2020 (ended March 31, 2021) totaled 8,729.1 billion yen ($78.6 billion), with 871 consolidated subsidiaries and approximately 350,000 employees worldwide. For more information on Hitachi, please visit the company’s website at https://www.hitachi.com.

Attachment

• The City of Belin taken at night

Rebecca Bleasdale
Hitachi Energy Ltd.
+41 78643 2613
rebecca.bleasdale@hitachienergy.com

BETTER SLEEP Achieves Primary Endpoint Across All Patient Cohorts

•  First clinical data demonstrating effectiveness of HGNS to treat CCC patients
•  As previously disclosed, confirms achievement of primary endpoint of AHI4 reductions for entire population, CCC cohort, and non-CCC cohort at six months, and reports 60%+ responder rates for all three cohorts
•  Exceeds 70% mean reduction in AHI4 among responders in both CCC and non-CCC cohorts

Mont-Saint-Guibert, Belgium – March 14, 2022, 11:30pm CET / 6:30pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH)(“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today provided additional data from its BETTER SLEEP clinical trial that it showcased in a poster presentation at the 16^th World Sleep Congress 2022. World Sleep, a global scientific congress, gathers leaders in sleep medicine and research from around the world for scientific sessions and networking.

Forty-two (42) moderate-to-severe OSA patients in the study received an implant at eight research sites in Australia, 18 of whom presented with Complete Concentric Collapse (CCC) of the soft palate and 24 who were classified as non-CCC. Three patients in each arm did not complete their six-month polysomnography, and as a result, the analysis was calculated based on 36 patients (15 CCC, 21 non-CCC). Of these 36 patients, there were 23 responders (64%), including nine of the 15 CCC patients (60%) and 14 of the 21 non-CCC patients (67%), at six months.

The primary endpoint was achieving at least a 4-point reduction in the apnea-hypopnea index (4% oxygen desaturation, or AHI4) from baseline at six months for the entire 42 patients. The overall reduction was statistically significant with an 11-point reduction (p<0.001), with statistically significant reductions of 10 points (p=0.001) in the CCC cohort and 11 points (p<0.001) in the non-CCC cohort. In addition, mean AHI4 reduction exceeded 70% among responders in both CCC and non-CCC cohorts. These results are subject to final review and validation.

“BETTER SLEEP represents the first clinical study to demonstrate the effectiveness of treating CCC patients with hypoglossal nerve stimulation (HGNS),” said Olivier Taelman, Chief Executive Officer of Nyxoah. “The results give us confidence that we will be able to provide a better treatment option for CCC patients, who comprise approximately 30% of the moderate-to-severe OSA population and are contraindicated for other HGNS options. These data validate our differentiated approach of delivering bilateral stimulation via an implantable device requiring only one incision, and a CCC indication would eliminate the need for patients to undergo an invasive DISE procedure.”

“We are also extremely encouraged to have generated such positive clinical results after just six months following implantation, as the growing body of clinical data and real-world experience suggests that patient responses improve meaningfully between months six and twelve,” continued Mr. Taelman. “The granting of an expanded CE mark indication to treat CCC patients and Breakthrough Device Designation from the U.S. FDA, both based on BETTER SLEEP, along with the high-level interest among the approximately 50 physicians in attendance at Nyxoah’s World Sleep symposium, underscore the strength of the data and excitement for the Genio platform. We continue to work with the FDA on an IDE approval to conduct a clinical trial for CCC patients in the U.S., which we aim to commence later this year.”

About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.

Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company is currently conducting the DREAM IDE pivotal study for FDA and US commercialization approval.

For more information, please visit http://www.nyxoah.com/.

Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.

Contacts:
Nyxoah
Loic Moreau, Chief Financial Officer
corporate@nyxoah.com
+32 473 33 19 80

Jeremy Feffer, VP IR and Corporate Communications
jeremy.feffer@nyxoah.com
+1 917 749 1494

Attachment

• ENGLISH_BETTER SLEEP Data PR Final