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
rhode Continues Its Global Retail Expansion Into Sephora Europe30.4.2026 19:00:00 EEST | Press release
rhode, the beauty brand founded by Hailey Rhode Bieber, will be available at Sephora online and in most stores across Europe beginning this September, following its 2025 rollout with Sephora in the U.S., Canada, and the U.K. This expansion into Sephora Europe increases global access to rhode through physical retail, marking a pivotal next stage for the brand. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260430569580/en/ rhode continues its global retail expansion into Sephora Europe. rhode’s collection of high-performance, skin-focused products saw strong performance in Sephora U.S. and Canada as the biggest brand launch in the retailer’s history in North America. When launched in November 2025 in the U.K., rhode was also the largest brand launch in Sephora U.K.’s history. “I’m so excited to continue our partnership with Sephora as we launch into retail in Europe, bringing rhode to more of our customers in a physical and I
ABS Acquires RMC Global to Strengthen Cyber, Risk and Resilience Capabilities30.4.2026 18:46:00 EEST | Press release
ABS, through its affiliate ABSG Consulting Inc. (ABS Consulting), has today announced the acquisition of RMC Global (RMC), a leading provider of industrial cybersecurity, risk management and resiliency solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260430164690/en/ (L to R): Vince Kuchar, President, RMC Global, and David Wechsler, President and CEO, ABS Group The acquisition strengthens ABS Consulting’s capabilities and market position, bringing together two organizations with complementary expertise, shared values and a common mission. Combining RMC’s capabilities with ABS Consulting’s scale, technical depth and global resources, unlocks more integrated solutions for clients operating in increasingly complex risk environments. ABS Chairman and CEO John McDonald said: “Clients are facing increasing operational risk, cyber threats, and regulatory pressure. Bringing together the expertise of RMC and ABS Consulting s
Brightfin Unveils AI-Native Platform for IT Financial Management30.4.2026 18:00:00 EEST | Press release
Brightfin, the only ITFM and Technology Expense Management solution built natively on ServiceNow, today announced an AI-Native architecture that fundamentally improves how organizations manage IT spend. Rather than bolting AI onto legacy systems, Brightfin has engineered intelligence from the ground up - starting with the data, building contextual awareness on top of it, and delivering AI agents that speak the language of IT finance. Brightfin’s unified budget-to-billing data model creates a stable, governed foundation that connects contracts, invoices, inventory, and budgets into a single source of truth - something no external ITFM tool or native platform module can replicate. This is a structured financial backbone purpose-built for enterprise IT spend, and it’s what makes everything above it possible. A context-aware, AI-Native, intelligence layer understands relationships across the entire IT financial lifecycle - which vendors map to which services, which contracts are approachin
Andersen Consulting Strengthens Digital Transformation Capabilities with Weexa30.4.2026 16:30:00 EEST | Press release
Andersen Consulting enters into a Collaboration Agreement with Weexa, a global provider of digital transformation, B2B integration, and supply chain digitalization solutions. Headquartered in France, Weexa delivers end-to-end services that help organizations streamline, secure, and scale their digital ecosystems. The firm specializes in B2B data-flow management and digitalization, enabling seamless communication between applications both within and across organizations through technologies such as EDI, APIs, and e-invoicing. Weexa also provides SAP integration and supply chain solutions spanning warehouse and transport management, alongside strategic consulting, project delivery, and third-party application maintenance. Serving organizations across the food, retail, wholesale, logistics, transportation, automotive, healthcare, and media sectors, Weexa supports global businesses in optimizing performance while meeting evolving regulatory and digital-compliance requirements. “Collaborati
SINOVAC Files Annual Report on Form 20-F for the Fiscal Year 202430.4.2026 16:22:00 EEST | Press release
Sinovac Biotech Ltd. (Nasdaq: SVA) (“SINOVAC” or the “Company”), a leading provider of biopharmaceutical products in China, today announced that it filed its annual report on Form 20-F for the fiscal year ended December 31, 2024 (the “Annual Report”) with the U.S. Securities and Exchange Commission (“SEC”). An electronic copy of the Annual Report can be accessed on SINOVAC’s investor relations website at https://www.sinovac.com/en-us/Investors and on the SEC’s website at www.sec.gov. About SINOVAC Sinovac Biotech Ltd. (SINOVAC) is a China-based global biopharmaceutical company, with a mission of “supply vaccines to eliminate human diseases”, the company specializes in the research, development, manufacturing and commercialization of vaccines and related biological products that protect against human infectious diseases. The company’s diversified portfolio includes vaccines for influenza, viral hepatitis, varicella, Hand-Foot-Mouth disease (HFMD), poliomyelitis, pneumococcal disease, et
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