PA-RELIEF-THERA/NEURORX
24.6.2020 07:32:05 CEST | Business Wire | Press release
NeuroRx, Inc., in partnership with RELIEF THERAPEUTICS Holding AG (SIX:RLF) “Relief” today announced that the U.S. Food and Drug Administration (FDA) awarded Fast Track designation to NeuroRx for the investigation of RLF-100 (Aviptadil) for the treatment of acute lung injury/acute respiratory distress syndrome associated with COVID-19. RLF-100 is a synthetic form of human Vasoactive Intestinal Peptide (VIP) which reduces inflammation in the lungs and protects the alveolar type II cells that are believed to be an entry route for the SARS-CoV-2 to invade the lungs.
As part of NeuroRx's enrollment in the Fast Track program, the FDA has requested that NeuroRx submit a publicly-available expanded access policy, so that physicians may request RLF-100 for their patients who are being treated in hospitals not participating in the ongoing Phase 2/3 clinical trials.
“We at NeuroRx are enormously appreciative of the FDA's commitment to accelerating the development of any potential treatment for COVID-19. We hope to live up to the trust that has been placed in us by bringing a life-saving treatment to patients ,” said Prof. Jonathan Javitt, MD, MPH, CEO and Chairman of NeuroRx.
“This milestone demonstrates the effectiveness of the FDA CoronaVirus Treatment Acceleration Program and the FDA's achievement in rising up to address the most severe public health crisis of our lifetime, ” said former FDA Chief Counsel, Daniel Troy, a member of the Company's board of directors.
RLF-100 is being tested in Phase 2/3 clinical trials at major medical centers including the University of Miami, Houston Methodist Hospital, University of California-Irvine, the NYU Langone Medical Center, and the Rambam Healthcare Campus (Haifa, Israel). The multicenter clinical trial enrolls patients with Critical COVID-19 and respiratory failure in the hopes that RLF-100 can decrease mortality and improve blood oxygenation in this condition by rescuing alveolar type II cells from the SARS-CoV-2 virus.
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 VIP in Lung Injury
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, that is critical to transmission of oxygen to the body. VIP has a 20-year history of safe use in humans in multiple human trials for sarcoidosis, pulmonary fibrosis, asthma/allergy, and pulmonary hypertension.
COVID-19-related death is primarily caused by Respiratory Failure. Before this acute phase, however, there is evidence of early viral infection of the alveolar type II cells. These cells are known to have angiotensin converting enzyme 2 (ACE2) receptors at high levels, which serve as the route of entry for the SARS-CoV-2 into the cells. Corona Viruses are shown to replicate in alveolar type II cells, but not in the more numerous type 1 cells. These same alveolar type II cells have high concentrations of VIP receptors on their cell surfaces giving rise to the hypothesis that VIP could specifically protect these cells from injury.
Injury to the alveolar type II cells is an increasingly plausible mechanism of COVID-19 disease progression. (Mason 2020). These specialized cells replenish the more common type 1 cells that line the lungs. More importantly, type 2 cells manufacture surfactant that coats the lung and are essential for oxygen exchange. Other than RLF-100, no currently proposed treatments for COVID-19 specifically target these vulnerable type 2 cells.
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 rationale. Currently, Relief is concentrating its efforts on developing new treatments for respiratory disease indications.
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.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200623005956/en/
About Business Wire
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
Venture Global Announces Closing of $2.25 Billion of Senior Secured Notes11.6.2026 23:00:00 CEST | Press release
Venture Global LNG, Inc. (“Venture Global”) announced today that its wholly-owned subsidiary, Venture Global LNG, Inc. (the “Issuer”) has closed its offering of $1.125 billion aggregate principal amount of its 6.375% senior secured notes due 2034 (the “2034 Notes”) and $1.125 billion aggregate principal amount of its 6.625% senior secured notes due 2036 (the “2036 Notes” and, together with the 2034 Notes, the “Notes”). The Issuer used the gross proceeds from the offering to redeem all of the Issuer’s outstanding 8.125% senior secured notes due 2028 (the “Existing 2028 Notes”) and used cash on hand to pay the redemption premium and related fees and expenses for the offering and the redemption. The 2034 Notes will mature on December 15, 2034, and the 2036 Notes will mature on June 15, 2036. The Notes were issued at par. The Notes will initially not be guaranteed by any of the Issuer’s subsidiaries. In the future, certain of the Issuer’s subsidiaries that incur or guarantee certain amount
Venture Global and Atlantic-SEE Announce Expansion of Long-Term LNG Sales and Purchase Agreement with Greece11.6.2026 22:30:00 CEST | Press release
Deal doubles quantity of US LNG to be supplied by Venture Global, expanding existing partnership to bolster Central and Eastern European energy securityBuilds on Venture Global’s regasification capacity investment in the Alexandroupolis LNG import terminal to supply U.S. LNG to the region Today, Venture Global, Inc. (NYSE: VG) and ATLANTIC – SEE LNG TRADE S.A. of Greece announced an expansion of their existing Sales and Purchase Agreement (SPA) for the purchase of U.S. liquefied natural gas (LNG) from Venture Global for twenty years starting in 2030. Under the deal, Atlantic-SEE is doubling their existing contract with Venture Global from a minimum of 0.5 million tonnes per annum (MTPA) to 1.0 million tonnes per annum (MTPA). Atlantic-SEE LNG is a newly formed joint venture announced in November at the 6th Partnership for Transatlantic Energy Cooperation (PTEC) conference hosted in Athens, Greece between Greek companies AKTOR Group and DEPA Commercial. The announcement of this expanded
Merrithew® Expands Global Mindful Movement Leadership with Acquisition of the GYROTONIC® Organization11.6.2026 17:30:00 CEST | Press release
Strategic acquisition strengthens Merrithew International Inc.’s position as a leading global authority in mindful movement education, equipment, and wellness Merrithew®, a global leader in mindful movement education and equipment and creator of internationally recognized programs including STOTT PILATES®, ZEN•GA®, Halo® Training and Total Barre®, today announced the acquisition of the GYROTONIC® organization, creator of the globally respected GYROTONIC® and GYROKINESIS® methods. Founded by Juliu Horvath, the GYROTONIC® and GYROKINESIS® methods are internationally recognized for their distinctive approach to movement, combining fluidity, strength, mobility, coordination, and rehabilitation through specialized equipment and movement sequences. Practiced in studios and wellness centers worldwide, the methods have cultivated a deeply loyal global community of instructors, trainers, therapists, and movement professionals. The acquisition marks a significant milestone in Merrithew Internati
GigaDevice Expands Optical Communication Portfolio with New GD32E512 and GD32E252 Series MCUs for Optical Modules11.6.2026 16:00:00 CEST | Press release
GigaDevice, a leading semiconductor company specializing in Flash memory, 32-bit microcontrollers (MCUs), sensors, and analog products, has introduced the new GD32E512 and GD32E252 series MCUs specifically designed for optical module applications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260611850679/en/ Empowering Optical Interconnect Innovation, GigaDevice Unveils Dedicated MCUs for Optical Modules. As a leading supplier of MCUs for optical module applications, GigaDevice has maintained a strong focus on the optical communication market, continuously aligning its product development with evolving industry requirements and next-generation optical interconnect technologies. Leveraging years of expertise in optical module control solutions, GigaDevice has established a strong position in the market through continuous innovation and close collaboration with industry partners. To further support the advancement of high-sp
Saudi Arabia at the Center of the Global Water Industry as IDWS 2026 Reshapes the Future of Water11.6.2026 15:47:00 CEST | Press release
In an increasingly resource-constrained world, water has become critical to both economic growth and national security, driving demand for global leadership in sustainability, innovation, and water solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260611388456/en/ Saudi Arabia at the Center of the Global Water Industry as IDWS 2026 Reshapes the Future of Water (Graphic: AETOSWire) The Saudi Water Authority has announced the return of the Innovation Driven Water Sustainability Conference (IDWS), taking place from 7 to 9 December 2026 at The Ritz-Carlton, Jeddah, as the Kingdom consolidates its position at the center of the global water conversation. As home to one of the world’s most advanced and rapidly evolving water management ecosystems, Saudi Arabia currently operates more than 500 water production facilities across the Kingdom with total water production capacity exceeding 16.2 million cubic meters per day. The
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