Business Wire

PA-RELIEF-THERAPEUTICS

29.7.2020 07:32:11 CEST | Business Wire | Press release

Share
FDA grants Expanded Access Protocol to RLF-100 (Aviptadil) for Respiratory Failure in COVID-19

RELIEF THERAPEUTICS Holding AG (SIX:RLF, OTC:RLFTF) “Relief” and its U.S. partner, NeuroRx, Inc. today announced that FDA has granted an Expanded Access Protocol for treatment of Respiratory Failure in COVID-19 with RLF-100 (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP). The protocol makes treatment available to patients who have exhausted standard therapies and are not eligible for the current phase 2/3 trial of RLF-100 because of confounding medical conditions and specifically makes the treatment available to pregnant women. Although the drug remains under investigation, rapid recovery from respiratory failure in COVID-19 has been seen in patients treated under FDA Emergency Use authorization.1

The expanded access protocol may be viewed on www.clinicaltrials.gov NCT04453839. Physicians who wish to enroll their patients in the protocol must submit the protocol to their local investigational review board and file FDA form 1572 with NeuroRx, Inc. Further information may be obtained from expandedaccess@neurorxpharma.com .

“By granting this Expanded Access protocol, FDA has made a potentially lifesaving drug immediately available to critically ill patients who have no other available treatment,” said Dr. Jonathan C. Javitt, MD, MPH, NeuroRx’s CEO. “We thank the FDA’s pulmonary division for its rapid and proactive implementation of the Coronavirus Treatment Acceleration Program, and we aspire to demonstrate broad safety and efficacy for RLF-100 in our ongoing clinical trial .”

The SARS-CoV-2 coronavirus that causes COVID-19 attacks the body by entering the small population of Alveolar Type II cells in the lung.2 Without Type II cells, the lung cannot transmit oxygen, which why the coronavirus causes acute respiratory failure. 50 years of scientific research demonstrates that VIP binds specifically to the Type II cell and protects that cell against cytokines (inflammatory molecules) and a wide array of toxic and infectious injuries.”3

About RELIEF THERAPEUTICS Holding AG

The Relief group of companies focus primarily on clinical-stage projects based on molecules of natural origin (peptides and proteins) with a history of clinical testing and use in human patients or a strong scientific rational. Currently, Relief is concentrating its efforts on developing new treatments for respiratory disease indications.

Relief Therapeutics holds orphan drug designations from the U.S. Food and Drug Administration and the European Union for the use of VIP to treat ARDS, pulmonary hypertension, and sarcoidosis. Relief Therapeutics also holds a U.S. patent4 for RLF-100 and proprietary manufacturing processes for its synthesis.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF (ISIN: CH0100191136).

About NeuroRx, Inc.

NeuroRx draws upon more than 100 years of collective drug development experience and is led by former senior executives of Johnson & Johnson, Eli Lilly, Pfizer, and AstraZeneca, PPD. In addition to its work on RLF-100, NeuroRx has been awarded Breakthrough Therapy Designation and a Special Protocol Agreement to develop NRX-101 for the treatment of suicidal bipolar depression and is currently in Phase 3 trials.

Disclaimer : This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, NeuroRx, Inc. and their businesses. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG and/or NeuroRx, Inc. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.


1 Youssef JG, Rapid Clinical Recovery from Critical COVID-19 with Respiratory Failure in a Lung Transplant Patient Treated with Intravenous Vasoactive Intestinal Peptide doi: 10.20944/preprints202007.0178.v1

2 Mason R. Pathogenesis of COVID-19 from a Cell Biologic Perspective. Eur Respir J. April 9 Epub ahead of print. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7144II60/

3 https://www.authorea.com/users/321659/articles/472151-vasoactive-intestinal-peptide-treats-respiratory-failure-in-covid-19-by-rescuing-the-alveolar-type-ii-cell

4 US 8,178,489 Formulation for Aviptadil

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Beyond the ‘Dumb Pipe’: How Agentic AI and Sovereign Networks Are Redefining Connectivity23.6.2026 14:46:00 CEST | Press release

The global connectivity market is shifting. With traditional European telecom growth slowing to 2-3% by 2029, businesses must adapt through Agentic AI, critical communications, and digital sovereignty. To remain competitive, operators should move beyond infrastructure toward an API-driven economy. These trends took center stage at Comarch User Group 2026. The conference hosted over 700 partners from 53 countries, including 201 connectivity experts, highlighting how companies can thrive in regulated environments. As telecom growth slows, demand for broader connectivity solutions across satellite, logistics, and critical communications is surging. Operators must abandon the old 4G “dumb pipe” model, where they act merely as network providers charging only for raw data transmission, for an API-driven economy with programmable network quality, securely integrating 5G with new satellite and IoT ecosystems. - Marcin Kaleta, CEO at Comarch Communications Putting Agentic AI in the Driver's Sea

Mary Kay Extends Winning Streak With Fourth Year as #1 in Global Direct Selling Beauty23.6.2026 14:03:00 CEST | Press release

Euromonitor International Recognizes Mary Kay’s Sustained Leadership In Skin Care And Color Cosmetics Mary Kay Inc., the iconic beauty and entrepreneurship company, has once again been named the #1 Direct Selling Brand of Skin Care and Color Cosmetics in the World1 by Euromonitor International, sustaining its legacy of excellence for the fourth consecutive year. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260623487381/en/ Mary Kay Inc., the iconic beauty and entrepreneurship company, for the fourth year in a row has been named the #1 Direct Selling Brand of Skin Care and Color Cosmetics in the World by Euromonitor International. (Image Credit: Mary Kay Inc.) “Earning the #1 global ranking from Euromonitor for the fourth consecutive year comes as a powerful endorsement of the impact of our Independent Beauty Consultants around the world who drive our success every day,” said Ryan Rogers, Chief Executive Officer of Mary Kay

Kobie 2026 Heart of Loyalty Report Reveals Growing Gap Between Consumer Expectations and Brand Loyalty Strategies23.6.2026 14:00:00 CEST | Press release

Global study finds consumers are more ready for AI, more willing to share data, and more motivated by recognition and shared values than many brands realize Kobie, a global leader in loyalty technology and services, today released its 2026 Heart of Loyalty Report, which surveyed both consumers and practitioners, revealing significant gaps between consumer expectations and brand loyalty strategies across AI adoption, data sharing, recognition, advocacy, and community engagement. Kobie's 2026 Heart of Loyalty Report found that: 57% of consumers are willing to engage with AI-powered brand experiences, yet 56% of loyalty practitioners believe customers are not ready for AI. 77% of consumers want recognition from brands, but only 55% feel seen as individuals. 72% of consumers say they would refer a brand without an incentive, yet many referral strategies remain heavily dependent on rewards. Rewards are the strongest driver of willingness to share personal data, yet only 65% of practitioners

Veristat Strengthens Biostatistics, Drug Development Advisory, and People Leadership to Support Growth in Complex Clinical Development23.6.2026 13:05:00 CEST | Press release

Dr. Zhaohui Su and Dr. Gil Fine deepen Veristat’s biostatistics expertise, Scott Tarrant leads Strategic Drug Development Advisory, and Clint Wolfe joins as Chief Human Resources Officer VeristatTM, a global clinical research organization (CRO) and consultancy specializing in complex studies, today announced four strategic leadership hires that advance its mission to accelerate novel therapy approvals in complex disease areas, including cell and gene therapy, oncology, and rare disease. Building on its 30-year foundation in biostatistics and its recent acquisition of the medical writing and regulatory submission business of Certara, Veristat is deepening its scientific expertise and expanding its operational leadership to meet growing client demand. Dr. Zhaohui Su and Dr. Gil Fine join Veristat’s Strategic Drug Development Advisory team in biostatistical leadership roles, collaborating with Scott Tarrant, who has been named Executive Vice President of the team. In addition, Clint Wolfe

Bacardi Takes Full Ownership of TEELING® Irish Whiskey23.6.2026 13:00:00 CEST | Press release

Irish whiskey brand joins family-owned company’s portfolio of premium brands Bacardi Limited has announced the completion of a transaction that makes the family-owned company the sole owner of the Teeling Whiskey Company and the TEELING® Irish whiskey brand. Founders Jack and Stephen Teeling will remain a part of the brand, shaping its future and driving growth for the long term as strategic advisors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260623858211/en/ Three expressions of Teeling Irish Whiskey: Single Grain, Small Batch and Single Malt Today’s announcement follows the successful relationship the two companies have enjoyed since Bacardi acquired a minority stake in the Dublin-based whiskey company in 2017. Bacardi subsequently increased its stake to become the majority shareholder in 2022. “TEELING is the perfect fit for Bacardi,” says Mahesh Madhavan, Chief Executive Officer, Bacardi Limited. “The brand stands f

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye