FDA grants Expanded Access Protocol to RLF-100 (Aviptadil) for Respiratory Failure in COVID-19
29.7.2020 08:30:00 EEST | Business Wire | Press release
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/
4 US 8,178,489 Formulation for Aviptadil
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200728005828/en/
Contact information
CORPORATE CONTACTS
US Inquiries
Jonathan C. Javitt, M.D., MPH
Chief Executive Officer
NeuroRx, Inc.
ceo@neurorxpharma.com
European Inquiries:
Yves Sagot, Ph.D.
Relief Therapeutics Holding, SA
yves.sagot@relieftherapeutics.com
MEDIA CONTACT
David Schull
Russo Partners, LLC
david.schull@russopartnersllc.com
858-717-2310
INVESTOR RELATIONS
Brian Korb
Solebury Trout
bkorb@troutgroup.com
917-653-5122
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Mary Kay’s Pink Changing Lives ® Program Turns Purpose Into Measurable Impact for Women Around the World6.8.2026 15:05:00 EEST | Press release
Mary Kay Inc., a global advocate for women’s empowerment, proudly reaffirms its commitment to enriching women’s lives worldwide through its signature Pink Changing Lives® Program – a multi-faceted global initiative that blends purpose-driven giving with cause-marketing to create meaningful, measurable impact across communities. Since 1996, the program has provided over $230 million in monetary and product donations to nonprofit organizations empowering women, transforming women’s health and safety, and protecting our natural resources. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806671194/en/ Mary Kay China supports the Hope for Pearl Program, providing financial assistance to girls from economically disadvantaged areas to receive a life-changing education, opening doors to new possibilities and bright futures. (Photo Courtesy: Mary Kay China) Rooted in the Company’s mission of enriching women’s lives, the Pink Changin
Omilia Secures $67 Million in Series B Funding to Accelerate Global Expansion of Its Agentic Self-Learning CX Platform for Large Enterprises6.8.2026 15:00:00 EEST | Press release
Omilia, the Self-Learning Agentic CX company trusted by many of the world's largest enterprises, today announced a $67 million Series B funding round led by transatlantic software & AI specialist, Expedition Growth Capital. Omilia builds Agentic CX for the world's largest and most demanding enterprises – organizations often in regulated industries such as banking, insurance and healthcare, where security, scalability and cost predictability are non-negotiable. Its customers include Capital One, Discover, RBC, Taco Bell, DWP and PSEG. The company's voice-first AI platform, honed over more than 200 enterprise deployments, is built entirely on its own proprietary agentic Voice AI technology, and supports the most stringent enterprise security and compliance standards, including FedRAMP, PCI-DSS, SOC 2, HIPAA and GDPR. Omilia runs some of the largest agentic voice deployments in production today. These include a Tier 1 US bank handling well over 1 million calls per day, and one of the worl
Perpetuals Reports 380% Hypothetical Return in Backtest of AI Engine Powering Risk-Free Trading Platform ‘UpsideOnly’6.8.2026 15:00:00 EEST | Press release
Perpetuals.com Ltd (Nasdaq: PDC) today announced backtest results for version two of BayesShield, its patent-pending AI engine developed for UpsideOnly. UpsideOnly is a risk-free paper trading platform where users simulate trades using virtual money across global equity, commodity, foreign exchange and crypto markets. The platform is powered by BayesShield, an AI model that uses machine learning to identify consistently successful traders. It generates automated signals when enough qualified traders independently take the same position at approximately the same time. These signals inform UpsideOnly's trading strategies, with profits shared among eligible top-performing users. Using the same production code that powers the live platform, Perpetuals replayed approximately 1.07 billion historical order fills. Over the 375-day test period, the strategy generated a hypothetical, non-compounded return of 380%, with a maximum drawdown, meaning its largest decline from a previous peak, of 27%.
Adtran launches Mosaic One Fabric, empowering operators to build custom AI agents and workflows6.8.2026 15:00:00 EEST | Press release
Adtran today launched Mosaic One Fabric, an expansion of its Mosaic One software platform, enabling operators to create AI agents and workflows around their own operational priorities. Rather than being limited to predefined agents, fixed use cases or vendor-controlled ecosystems, operators can build and scale AI on their own terms using the data, tokens and models that best fit their business, with the token economics visible and under their control. Mosaic One Fabric brings together trusted operational intelligence, vendor-agnostic AI integration and the guardrails needed to run AI safely across the network. By combining Adtran capabilities with their own agents and models, operators can create AI workflows that reflect the way their organization actually works. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806266488/en/ Adtran’s Mosaic One Fabric gives operators the freedom to create AI agents and workflows aligned wi
NetApp Acquires JetStream Software to Advance Cyber Resilience and Data Protection for the AI Era6.8.2026 15:00:00 EEST | Press release
NetApp® (NASDAQ: NTAP), the Intelligent Data Infrastructure company, today announced it has acquired JetStream Software, a leader in VMware disaster recovery and migration. Enterprise customers continue to rely on VMware for many of their most critical applications. As organizations evaluate cloud adoption, they often seek ways to transition workloads while minimizing cost, complexity, and operational disruption. For many, disaster recovery serves as a practical first step, with production workloads migrating over time as cloud strategies mature. “Data has become the foundation for business growth, AI innovation, and operational continuity,” said George Kurian, Chief Executive Officer at NetApp. “As customers look to unlock greater value from their data while strengthening protection against disruption, bringing JetStream into NetApp expands our ability to help keep their data secure, available, and ready for what comes next. This acquisition further positions NetApp as a leader in ent
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