09:33 uur 29-07-2020

FDA verleent uitgebreid toegangsprotocol aan RLF-100 (Aviptadil) voor respiratoire insufficiëntie in COVID-19

Het protocol voor uitgebreide toegang, ook voor zwangere vrouwen, komt beschikbaar voor patiënten die niet in aanmerking komen voor inschrijving in de klinische proef van RLF-100 door de FDA,
RLF-100, een gepatenteerde formulering van Aviptadil, wordt momenteel ontwikkeld door NeuroRx en RELIEF THERAPEUTICS Holding AG onder Fast Track Designation, en heeft onlangs een positief veiligheidsadvies gekregen van de commissie voor gegevensbewaking.

GENEVA & RADNOR, Pa .– (BUSINESS WIRE) – RELIEF THERAPEUTICS Holding AG (ZES: RLF, OTC: RLFTF) “Relief” en zijn Amerikaanse partner, NeuroRx, Inc. hebben vandaag aangekondigd dat de FDA een Expanded Access Protocol heeft toegekend voor de behandeling van Ademhalingsfalen in COVID-19 met RLF-100 (aviptadil), een synthetische vorm van Vasoactive Intestinal Peptide (VIP). Het protocol maakt behandeling beschikbaar voor patiënten die uitgeputte standaardtherapieën hebben en niet in aanmerking komen voor de huidige fase 2/3 studie van RLF-100 vanwege verwarrende medische aandoeningen, en maakt de behandeling specifiek beschikbaar voor zwangere vrouwen. Hoewel het geneesmiddel nog steeds wordt onderzocht, is snel herstel van respiratoire insufficiëntie bij COVID-19 waargenomen bij patiënten die werden behandeld met toestemming van de FDA voor noodgevallen.1

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

Expanded access protocol, including for pregnant women, is becoming available to patients who are ineligible for enrollment in the FDA clinical trial of RLF-100,
RLF-100, a patented formulation of Aviptadil, is currently in development by NeuroRx and RELIEF THERAPEUTICS Holding AG under Fast Track Designation, and recently obtained positive safety opinion from the data monitoring committee.

GENEVA & RADNOR, Pa.–(BUSINESS WIRE)– 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