NeuroRx and Relief Conclude Enrollment in their Phase 2b/3 Trial of RLF-100™ for Critical COVID-19 with Respiratory Failure

Rhea-AI Summary

NeuroRx and RELIEF THERAPEUTICS have completed enrollment in a critical phase 2b/3 trial for ZYESAMI™ (RLF-100) targeting respiratory failure in COVID-19 patients. The enrollment increased from 165 to gather extensive safety data with no serious adverse events reported. Top line results are expected between January and February 2021. The FDA previously denied Emergency Use Authorization but remains engaged in product development. ZYESAMI™ is administered under expanded access protocols for critically ill patients, aiming to replicate existing encouraging results.

Positive

• Enrollment increased to enhance safety database.
• Top line data expected in early 2021.
• No drug-related serious adverse events reported.

Negative

• FDA denied Emergency Use Authorization for ZYESAMI™.

RADNOR, Pa. and GENEVA, Switzerland, Dec. 30, 2020 /PRNewswire/ -- NeuroRx, Inc. and RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) ("Relief") today announced the conclusion of enrollment in the phase 2b/3 trial of ZYESAMI™ (previously RLF-100^TM: aviptadil) for the treatment of Respiratory Failure in patients with Critical COVID-19 (www.clinicaltrials.gov NCT04311697). No drug-related serious adverse events have been reported as of today. Enrollment was increased from 165 patients in order to amass as large a safety database as possible. Top line data are expected in late January - early February 2021.

"With FDA's authorization and the extraordinary dedication of our twelve clinical trial sites, we were able to take a drug not formulated or administered to patients in IV form since 2005 and advance it to the clinic in ten weeks. We hope that the highly encouraging results seen in the most critically-ill COVID-19 patients treated in our expanded access program can be replicated in patients who have Critical COVID-19 without an advanced comorbidity" said Prof. Jonathan Javitt, CEO and founder of NeuroRx, Inc. "The FDA did not agree to grant EUA, as applied for in September, based upon the open-label study reported earlier, but has advised us that they remain committed to working with us in the development of our product and will promptly review the forthcoming data from this randomized trial. Until that time, available stocks of ZYESAMI^TM (RLF-100^TM) will continue to be administered under our Expanded Access Protocol and individual patient requests under Right to Try laws."

Raghuram (Ram) Selvaraju, Chairman of the Board of Relief, said: "We congratulate NeuroRx on the successful completion of patient enrollment in this crucial pivotal clinical study and look forward to the top line results. Our fervent hope is for RLF-100^TM to bring benefit to critically ill patients suffering the consequences of COVID-19 infection." 

About VIP in COVID-19

Vasoactive Intestinal Polypeptide (VIP) was first discovered by the late Dr. Sami Said in 1970. Although first identified in the intestinal tract, VIP is now known to be produced throughout the body and to be primarily concentrated in the lungs. VIP has been shown in more than 100 peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, 70% of the VIP in the body is bound to a rare cell in the lung, the alveolar type II cell (ATII), that is critical to transmission of oxygen to the body. 

COVID-19-related respiratory failure is caused by selective infection of the ATII cell by the SARS-CoV-2 virus. They are vulnerable because of their (ACE2) surface receptors, which serve as the route of entry for the virus. These specialized cells manufacture surfactant that coats the lung and is essential for oxygen exchange. Loss of surfactant causes collapse of the air sacs (alveolae) in the lung and results in respiratory failure.

VIP is shown to block Coronavirus replication in the ATII cell, block cytokine synthesis, block viral-induced cell death (cytopathy), and upregulate surfactant production. Other than RLF-100™, no currently proposed treatments for COVID-19 specifically target these vulnerable Type II cells.

About ZYESAMI™ (previously RLF-100™: aviptadil)

ZYESAMI™ (RLF-100^TM: Aviptadil) is a formulation of Vasoactive Intestinal Polypeptide (VIP) that was developed based on Prof. Sami Said's original work at Stony Brook University, for which Stony Brook was awarded an FDA Orphan Drug Designation in 2001. VIP is known to be highly concentrated in the lungs, where it inhibits coronavirus replication, blocks the formation of inflammatory cytokines, prevents cell death, and upregulates the production of surfactant. FDA has now granted IND authorization for intravenous and inhaled delivery of aviptadil for the treatment of COVID-19 and awarded Fast Track designation. ZYESAMI is being investigated in two placebo-controlled US Phase 2b/3 clinical trials in respiratory deficiency due to COVID-19. Since July 2020, more than 300 patients with Critical COVID-19 and Respiratory Failure have been treated with RLF-100™ between the two FDA-cleared protocols (randomized and expanded access). Information on the RLF-100™ Expanded Access Program can be found at https://www.neurorxpharma.com/our-services/rlf-100.

About NeuroRx, Inc.

NeuroRx draws upon more than 100 years of collective drug development experience and by former senior executives of AstraZeneca,, Eli Lilly, Novartis, Pfizer, and PPD. In addition to its work on ZYESAMI, which has been awarded FDA Fast Track designation (previously RLF-100™: Aviptadil), NeuroRx has been awarded Breakthrough Therapy Designation and a Special Protocol Agreement to develop NRX-101 in suicidal bipolar depression and is currently in Phase 3 trials. Its executive team is led by Prof. Jonathan C. Javitt, MD, MPH, who has served as a health advisor to four Presidential administrations and worked on paradigm-changing drug development projects for Merck, Allergan, Pharmacia, Pfizer, Novartis, and Mannkind, together with Robert Besthof, MIM, who served as the Global Vice President (Commercial) for Pfizer's Neuroscience and Pain Division. The Company has recently announced a plan to merge with Big Rock Partners Acquisition Corp (NASDAQ: BRPA), following which it plans to trade on the NASDAQ as NRXP.

About RELIEF THERAPEUTICS Holding AG

Relief focuses primarily on clinical-stage programs based on molecules of natural origin (peptides and proteins) with a history of clinical testing and use in human patients or a strong scientific rationale. Currently, Relief is concentrating its efforts on developing new treatments for respiratory disease indications. Its lead drug candidate RLF-100^TM (aviptadil) is being investigated in two placebo-controlled U.S. phase 2b/3 clinical trials in respiratory deficiency due to COVID-19. Relief also holds a patent issued in the United States and various other countries covering potential formulations of RLF-100^TM.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF.
www.relieftherapeutics.com 

Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, NeuroRx, Inc. and their businesses. The results reported herein may or may not be indicative of the results of future and larger clinical trials for RLF-100™ for the treatment of COVID-19. 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.

CORPORATE CONTACTS

NeuroRx, Inc.
Jonathan C. Javitt, M.D., MPH
Chairman and Chief Executive Officer
ceo@neurorxpharma.com   

RELIEF THERAPEUTICS Holding AG
Raghuram (Ram) Selvaraju, Ph.D., MBA
Chairman of the Board
contact@relieftherapeutics.com

MEDIA CONTACT

NeuroRx (United States):
David Schull
Russo Partners, LLC
david.schull@russopartnersllc.com
858-717-2310

Relief (Europe):
Anne Hennecke / Brittney Sojeva
MC Services AG
relief@mc-services.eu
+49 (0) 211-529-252-14

INVESTOR RELATIONS

NeuroRx (United States)
Brian Korb
Solebury Trout
bkorb@troutgroup.com
917-653-5122

Relief (Europe):
Anne Hennecke / Brittney Sojeva
MC Services AG
relief@mc-services.eu
+49 (0) 211-529-252-14

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SOURCE NeuroRx

FAQ

What is the purpose of the phase 2b/3 trial for ZYESAMI™?

The trial aims to assess the safety and efficacy of ZYESAMI™ in treating respiratory failure in critically ill COVID-19 patients.

When will the results of the phase 2b/3 trial for ZYESAMI™ be available?

Top line data from the trial are expected to be released between late January and early February 2021.

What is the current status of ZYESAMI™ in the treatment of COVID-19?

ZYESAMI™ is currently administered under expanded access protocols while awaiting trial results.

How many patients were enrolled in the ZYESAMI™ trial?

Enrollment in the trial was increased from 165 patients to gather a larger safety database.

What was the FDA's recent action regarding ZYESAMI™?

The FDA denied Emergency Use Authorization for ZYESAMI™ but remains committed to reviewing forthcoming trial data.