NeuroRx and Relief Therapeutics Announce Data Monitoring Committee Determination to Continue Phase 2/3 Trial of RLF-100 for Critical COVID-19
16.7.2020 08:00:00 EEST | Business Wire | Press release
NeuroRx, Inc., in partnership with RELIEF THERAPEUTICS Holdings AG (OTC:RLFTF, SIX:RLF) today announced that the independent Data Monitoring Committee has reviewed the findings in the first 30 patients treated in Fast Track FDA trials of RLF-100 (Aviptadil) in patients with Critical COVID-19 with respiratory failure.
The study protocol enrolls patients with Critical COVID-19 and Respiratory Failure and randomly assigns them to intravenous RLF-100 or Placebo in the hopes of achieving remission from this most-serious stage of COVID-19. At the committee’s recommendation, the primary endpoint is changed to “alive and free of respiratory failure at 7-10 days.” This change in primary endpoint from mortality at 28 days is driven by the general decrease in mortality with advances in treatment for Critical COVID-19 and by initial observations in the clinical trial.
This first interim analysis was focused on verifying the apparent safety of the drug in the first 30 patients and the feasibility of the study to reach its endpoint. The committee determined that the study appeared capable of reaching a statistically significant endpoint within its 144 patient sample size and voted for the study to continue until its next scheduled evaluation in four weeks.
The committee is composed of Prof. Alfred Sommer, MD, MHS, Dean Emeritus of the Johns Hopkins Bloomberg School of Public Health, Prof. Rita Colwell, PhD, former Director of the National Science Foundation, and Congressman, Andy Harris, MD, MHS (MD District 1) a part time Professor of Anesthesia and Critical Care at Johns Hopkins School of Medicine.
RLF-100 (Aviptadil) received Fast Track designation from the US FDA for the treatment of Critical COVID-19 with respiratory failure. Aviptadil is a synthetic form of human Vasoactive Intestinal Peptide (VIP) which is known to protect the Alveolar Type II cell of the lung from many forms of injury. This cell is critical to transmission of oxygen to the blood and is the site of attack for the Coronavirus.
“This milestone represents the extraordinary effort of our partners and collaborators at the University of Miami, Houston Methodist Hospital, UC Irvine, and University of Louisville who gave 100% to providing patients with Critical COVID-19 a chance to benefit from a potentially life-saving drug. We thank the members of the Data Monitoring Committee for devoting their valuable time to performing this vital role in helping to evaluate the safety and effectiveness of RLF-100,” said Prof. Jonathan C Javitt, MD, MPH, CEO of NeuroRx and the National Study Chair.
Details of the study are posted on clinicaltrials.gov NCT04311697.
About RLF-100
RLF-100 (Aviptadil) is a patented formulation of Vasoactive Intestinal Polypeptide (VIP) that was developed based on Dr. Said’s original work and was originally approved for human trials by the FDA in 2001 and the European Medicines Agency in 2005. VIP is primarily concentrated in the lung and is known to protect against a variety of lung injuries. VIP was awarded Orphan Drug Designation in 2001 by the U.S. FDA for treatment of Acute Respiratory Distress Syndrome and in 2005 for treatment of Pulmonary Arterial Hypertension. The European Medicines Agency awarded orphan drug designation in 2006 for the treatment of acute lung injury and in 2007 for the treatment of sarcoidosis.
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. patent1 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.
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. Its Board of Directors and Advisors includes Hon. Sherry Glied, former Assistant Secretary, U.S. Dept. of Health and Human Services; Mr. Chaim Hurvitz, former President of the Teva International Group, Lt. Gen. HR McMaster, the 23rd National Security Advisor, Wayne Pines, former Associate Commissioner of the U.S. Food and Drug Administration, Judge Abraham Sofaer, and Daniel Troy, former Chief Counsel, U.S. Food and Drug Administration.
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 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/20200715005954/en/
Contact information
CORPORATE CONTACTS
Jonathan C. Javitt, M.D., MPH
Chief Executive Officer
NeuroRx, Inc.
ceo@neurorxpharma.com
Yves Sagot, Ph.D.
Relief Therapeutics Holding, SA
yves.sagot@relieftherapeutics.com
MEDIA CONTACT
Gloria Gasaatura
LifeSci Communications
ggasaatura@lifescicomms.com
646-970-4688
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
Wyss Geneva Steps Into Its Next Chapter11.6.2026 14:33:00 EEST | Press release
The Wyss Center for Bio and Neuroengineering in Geneva is pleased to announce the appointment of Dr. Tracy Laabs as Director, effective July 1st 2026. Dr. Laabs succeeds Prof. Dr. Erwin Böttinger, who leaves behind a fundamentally transformed organization: one that no longer just pursues breakthrough science but systematically turns it into ventures that reach patients. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260611328520/en/ Dr. Tracy Laabs, incoming Director, Wyss Center Geneva Since joining the Wyss Center as Director in April 2023, Prof. Böttinger brought a bold vision: to evolve the Center from a portfolio of promising projects into a disciplined engine for venture creation. Under his leadership, the Center spun off six companies in two years (including ABILITY Neurotech SA and Clee Medical SA in 2025) while simultaneously building a robust pipeline of next-generation programs in AI-guided neuromodulation and min
BeOne Showcases Landmark Phase 3 Data in CLL Patients Aged 80+ at EHA 2026, Reinforcing BRUKINSA Benefit11.6.2026 14:24:00 EEST | Press release
BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced the presentation of a large Phase 3 dataset in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) aged 80 and older, showing sustained benefit with BRUKINSA after nearly 6.5 years of follow-up, reinforcing its role as the foundational BTK inhibitor. BRUKINSA is the only BTK inhibitor to demonstrate superior efficacy vs. ibrutinib in a Phase 3 trial.1 These data, one of the largest datasets of older patients with treatment-naive CLL, will be presented at the 2026 European Hematology Association (EHA) Congress in Stockholm, Sweden. Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines, said: "While the median age of diagnosis for CLL is 70 and the average age of treatment initiation is 75, many pivotal trials still underrepresent the patients that physicians most often see in practice. These data show that the durable benefit of
Clearlake Expands Liquid Credit Platform With Acquisition of LCM Asset Management’s CLO Contracts11.6.2026 14:00:00 EEST | Press release
Clearlake Capital Group, L.P. (“Clearlake” or the “Firm”), a global investment firm managing integrated platforms spanning private equity, liquid and private credit, and other related strategies, today announced that its credit platform, Clearlake Credit, will assume management of CLOs managed by LCM Asset Management, LLC. The transaction adds 31 CLOs representing more than $5 billion of assets under management and increases assets managed by Clearlake Credit to approximately $39 billion across liquid credit, private credit, and other customized credit solutions. The acquisition further broadens the Firm’s capabilities, deepens its relationships with institutional investors, and reinforces its client-centric approach and commitment to seeking attractive risk-adjusted returns across market cycles. Milbank LLP and Dechert LLP represented Clearlake Credit in the transaction. GreensLedge Capital Markets advised the seller. About Clearlake Clearlake Capital is a leading global alternative a
Takeda’s Zasocitinib Significantly Outperforms Deucravacitinib in Head-to-Head Phase 3 Psoriasis Study, Promising to Redefine Oral Treatment Expectations11.6.2026 14:00:00 EEST | Press release
Takeda (TSE:4502/NYSE:TAK) announced positive topline results for the Phase 3, randomized, multicenter, double-blind study comparing zasocitinib (TAK-279), an investigational, next-generation, highly selective and potent oral tyrosine kinase 2 (TYK2) inhibitor, to deucravacitinib in adults with moderate-to-severe plaque psoriasis (PsO). In the LATITUDE Atlas (TAK-279-PsO-3004) head-to-head study, zasocitinib demonstrated statistical superiority over deucravacitinib for the primary endpoint, Psoriasis Area and Severity Index (PASI) 100 response rate at week 16. The study also demonstrated statistical superiority over deucravacitinib for all key secondary endpoints, including PASI 90 response and Static Physician's Global Assessment (sPGA) 0 at week 16. Zasocitinib was generally well tolerated with a consistent safety and tolerability profile and no new safety signals identified. Perspectives on head-to-head zasocitinib study “In this head-to-head study, zasocitinib clearly demonstrated
L&T Technology Services, Databricks Partner to Deliver Industrial AI at Scale for Asset-Intensive Industries11.6.2026 13:30:00 EEST | Press release
L&T Technology Services (BSE: 540115, NSE: LTTS), a global leader in AI, Digital & ER&D Consulting Services, today announced a strategic go-to-market partnership with Databricks, the leading Data and AI company, to co-develop and deliver Industrial AI solutions that advance Engineering Intelligence (EI) for asset-intensive enterprises. Anchored in LTTS' Sustainability segment, spanning Process Engineering, Discrete Manufacturing and Industrial Products, the partnership will support Energy, Petrochemicals and Industrials clients globally. As industrial organizations seek to unlock greater value from decades of operational and engineering data, the alliance will combine LTTS’ deep domain capabilities with the Databricks platform to transform complex plant data into Engineering Intelligence - enabling improved asset reliability, operational efficiency and sustainability performance. The partnership brings together LTTS’ expertise in forward looking technologies and extensive experience ac
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