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
Vertex Announces US FDA Approval for Label Extensions of ALYFTREK ® and TRIKAFTA ® , Expanding Availability of These Medicines to ~95% of All People With CF in the United States1.4.2026 14:30:00 EEST | Press release
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved expanded use of ALYFTREK® (vanzacaftor/tezacaftor/ivacaftor) for the treatment of people with cystic fibrosis (CF) ages 6 and older with a variant in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein. Additionally, the U.S. FDA has also expanded the indication statement for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in patients ages 2 and older. This label expansion was supported by clinical and/or in vitro data from 564 variants demonstrating response to ALYFTREK and 521 variants demonstrating response to TRIKAFTA. As such, approximately 800 more people with a clinical diagnosis of CF in the U.S. are now eligible for a medicine that treats the underlying cause of their disease for the first time. This extension means approxim
Agenus Announces First Patient Enrolled in Global Phase 3 BATTMAN Trial of BOT+BAL Immunotherapy Combination in MSS or pMMR Metastatic Colorectal Cancer1.4.2026 14:30:00 EEST | Press release
Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced that the first patient has been enrolled in the landmark global phase 3 BATTMAN (CO.33) trial (NCT07152821). This study is evaluating Agenus’ immunotherapy combination of botensilimab (BOT) plus balstilimab (BAL) versus best supportive care in patients with refractory, unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR) metastatic colorectal cancer (mCRC), a population long considered resistant to immunotherapy. This study is being conducted as a cooperative group trial led by the Canadian Cancer Trials Group (CCTG) from Canada and run across Canada, France, Australia and New Zealand. More than 100 sites will participate across the academic cooperative networks of CCTG, GI Cancer Trials in Australia and France’s Partenariat de Recherche en Oncologie Digestive (PRODIGE) consortium (including Unicancer, GERCOR and FFCD). The BATTMAN (CO.33) trial serves as the registrational-enablin
Klarna Agrees to $1.7 Billion Transaction Supporting up to $40B+ of Lending1.4.2026 14:19:00 EEST | Press release
Klarna, the global digital bank and flexible payments provider, has entered into a new capital efficiency transaction in the form of a Significant Risk Transfer (SRT), covering $1.7 billion-worth of Euro denominated loans and freeing up capital to support continued growth. Klarna has entered into a three-year agreement with a consortium led by Värde Partners. This is Klarna's sixth SRT transaction and improves how effectively Klarna deploys its capital on a global basis. "Our banking license is one of our biggest competitive advantages," said Niclas Neglén, Klarna's Chief Financial Officer. "This is our largest and most efficient SRT transaction to date. These transactions allow us to maximize every unit of capital to support our continued momentum." The transaction follows Klarna’s recently announced $2 billion facility supporting $17B of US Financing expansion. About Klarna Klarna is a global digital bank and flexible payments provider. With over 118 million global active Klarna user
Americhem Launches nDryve™: PFAS-Free In-Melt Technology Platform for Functional Fibers1.4.2026 14:00:00 EEST | Press release
Americhem, Inc., a global polymer solutions provider, today announced the launch of nDryve™, a PFAS-free, in-melt surface-modifying technology platform designed to deliver durable multi-fluid repellency against alcohol and other low-surface-energy fluids in fiber systems. As global regulations accelerate the phase-out of per- and polyfluoroalkyl substances (PFAS), manufacturers are under increasing pressure to maintain barrier performance without fluorinated chemistries. nDryve™ was developed to address this shift, offering a PFAS-free, in-melt alternative to conventional surface applied treatments. Engineered for Performance Without PFAS Often referred to as “forever chemicals,” PFAS have come under heightened regulatory scrutiny due to their persistence and potential environmental and health impacts. nDryve™ integrates directly into the polymer during melt processing, embedding surface-modifying functionality within the fiber matrix rather than relying on removable finishes. By engin
Biocytogen and Sihuan Pharmaceutical Announce Strategic Partnership in Weight Loss and Beyond1.4.2026 14:00:00 EEST | Press release
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, today announced a strategic partnership with Sihuan Pharmaceutical Holdings Group Ltd. (Sihuan Pharmaceutical; HKEX: 00460). Under the agreement, both parties will combine Biocytogen’s leading fully human antibody discovery platform with Sihuan Pharmaceutical’s extensive capabilities in drug development, manufacturing, and commercialization. The collaboration will focus on advancing innovative therapies across multiple disease areas, including weight loss, leveraging complementary strengths to drive synergies and establish a long-term strategic partnership. Sihuan Pharmaceutical highly values the strength of Biocytogen’s technology platforms. In this collaboration, Biocytogen will leverage its integrated platforms, including proprietary target-humanized mouse models and
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