RLF-100 (aviptadil) clinical trial showed rapid recovery from respiratory failure and inhibition of coronavirus replication in human lung cells
NeuroRx, Inc. and Relief Therapeutics Holdings AG (SIX:RLF, OTC:RLFTF) “Relief” today announced that RLF-100 (aviptadil) showed rapid recovery from respiratory failure in the most critically ill patients with COVID-19. At the same time, independent researchers have reported that aviptadil blocked replication of the SARS coronavirus in human lung cells and monocytes.
RLF-100 has been granted Fast Track designation by FDA and is being developed as a Material Threat Medical Countermeasure in cooperation with the National Institutes of Health and other federal agencies. Further research will be conducted.
The first report of rapid clinical recovery under emergency use IND was posted by doctors from Houston Methodist Hospital. The report describes a 54-year-old man who developed COVID-19 while being treated for rejection of a double lung transplant and who came off a ventilator within four days.1 Similar results were subsequently seen in more than 15 patients treated under emergency use IND and an FDA expanded access protocol which is open to patients too ill to be admitted to the ongoing Phase 2/3 FDA trial.
Patients with Critical COVID-19 were seen to have a rapid clearing of classic pneumonitis findings on x-ray, accompanied by an improvement in blood oxygen and a 50% or greater average decrease in laboratory markers associated with COVID-19 inflammation.2clinicaltrials.gov NCT04311697.
The clinical findings may be based on evidence that VIP inhibits the replication of the SARS-CoV-2 virus in human lung cells and immune cells (monocytes). The work was reported by Brazilian researchers working in a level-4 biocontainment laboratory.3 The same researchers reported a case-control study in which patients who survived being on ventilators for COVID-19 had significantly higher levels of VIP in their blood than those who died of respiratory failure.
“No other antiviral agent has demonstrated rapid recovery from viral infection and demonstrated laboratory inhibition of viral replication,” said Prof. Jonathan Javitt, CEO and Chairman of NeuroRx. “We are conducting placebo-controlled trials to see whether the observations made in the case-control and open-label studies will be confirmed for less ill patients with COVID-19-related respiratory failure. Our independent Data Monitoring Committee will be conducting an interim analysis of these data later this month.”
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, which is critical for the 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 2 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. coronaviruses are shown to replicate in alveolar type 2 cells, but not in the more numerous type 1 cells. 2 These same type 2 alveolar 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 type 2 alveolar 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 is essential for oxygen exchange. Other than RLF-100, no currently proposed treatments for COVID-19 specifically target these vulnerable type 2 cells.
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 known to be highly concentrated in the lungs and to inhibit a variety of inflammatory cytokines. Relief’s predecessor company, Mondo Biotech, was awarded Orphan Drug Designation in 2001 by the U.S. FDA for aviptadil in the treatment of Acute Respiratory Distress Syndrome and in 2005 for treatment of Pulmonary Arterial Hypertension. Mondo was awarded Orphan Drug Designation by the European Medicines Agency in 2006 for the treatment of acute lung injury and in 2007 for the treatment of sarcoidosis. Both the U.S. FDA and the EMEA have granted Investigational New Drug licenses for human trials of aviptadil.
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 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
1 Youssef, J.G.; Zahiruddin, F.; Al-Saadi, M.; Yau, S.; Goodarzi, A.; Huang, H.J.; Javitt, J.C. Brief Report: Rapid Clinical Recovery from Critical COVID-19 with Respiratory Failure in a Lung Transplant Patient Treated with Intravenous Vasoactive Intestinal Peptide. Preprints2020, 2020070178 (doi: 10.20944/preprints202007.0178.v1). https://www.preprints.org/manuscript/202007.0178/v1
3Temerozo JR, Sacramenta Q, Fintelman-Rodriques N, et. al. The neuropeptides VIP and PACAP inhibit SARS-CoV-2 replication in monocytes and lung epithelial cells, decrease the production of proinflammatory cytokines, and VIP levels are associated with survival in severe Covid-19 patients doi:https://doi.org/10.1101/2020.07.25.220806. https://www.biorxiv.org/content/10.1101/2020.07.25.220806v2.full
Dr. Yves Sagot
Chief Scientific Officer
Relief Therapeutics Holding AG
Jonathan C. Javitt, M.D., MPH
Chief Executive Officer
US - David Schull
Russo Partners, LLC
Europe - Raimund Gabriel, Laurie Doyle
MC Services AG
+49 89 210 2280
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
Velodyne Lidar, Inc. and Graf Industrial Corp. Announce Closing of Business Combination29.9.2020 22:01:00 CEST | Press release
Velodyne Lidar, Inc. (“Velodyne”) and Graf Industrial Corp. (“Graf”) jointly announced today that they have closed their previously announced business combination, pursuant to which Velodyne became a wholly owned subsidiary of Graf and Graf changed its name to Velodyne Lidar, Inc. The business combination was approved at a special meeting of Graf’s stockholders held today. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200929006064/en/ Beginning on Wednesday, September 30, 2020, the common stock and warrants of Velodyne Lidar, Inc., the post-combination company, are expected to begin trading on The Nasdaq Global Select Market under the ticker symbols “VLDR” and “VLDRW,” respectively. Graf’s units, common stock and warrants will cease trading on the New York Stock Exchange today. About Velodyne Lidar, Inc. Velodyne Lidar is a global leader in lidar technology providing real-time 3D vision for autonomous systems thereby empowe
PMI to Address Equality & Transformation During Upcoming International Events29.9.2020 16:22:00 CEST | Press release
Philip Morris International Inc. (PMI) (NYSE: PM) today announced its participation in several global forums focused on equality in the workplace. Members of PMI’s Senior Management Team—including Chief Diversity Officer Silke Muenster—will detail the steps PMI is taking to further diversify its workplace and explain how fostering a culture built on broader perspectives increases creativity and productivity, ultimately driving innovation and consumer-centricity. Events include: - Sept. 30: Marian Salzman, senior vice president, global communications, will address The Hill’shttps://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fthehill.com%2Fevent%2F517572-century-of-the-woman&esheet=52297021&newsitemid=20200929005799&lan=en-US&anchor=%26%238220%3BCentury+of+the+Woman%2C%26%238221%3B&index=2&md5=dd59f1acaf064094c36e98292381df3c “Century of the Woman,” anevent bringing together remarkable women leaders and decision-makers to discuss progress toward equality and the barriers th
SMITHS DETECTION INTRODUCES COMPACT X-RAY SCANNER FOR VERSATILE COMMERCIAL SECURITY APPLICATIONS29.9.2020 16:00:00 CEST | Press release
Smiths Detection announces its newest X-ray inspection system, HI-SCAN 5030C, that addresses a critical gap in commercial security screening solutions with its optimal size, durability and mobility. Combined with a market-leading HiTraX 3 electronic platform for superior image quality, the HI-SCAN 5030C is specifically designed to enhance security screening operations from courthouses to corporate campuses. Its compact size and lightweight construction enable it to fit seamlessly into checkpoints and mailrooms. Vibration absorbers make it possible to transport HI-SCAN 5030C between various locations without requiring re-calibration, providing maximum flexibility. The HI-SCAN 5030C is Smiths Detection’s smallest X-ray inspection system and offers a wide variety of options including stainless steel castors, storage compartment, 24” monitor, newly designed keyboard with image manipulation keys, and foldable input/output conveyors. It can be upgraded with add-on software packages for train
Andersen Global Strengthens Caribbean Presence with Addition of Templar Chambers29.9.2020 15:30:00 CEST | Press release
Andersen Global enters a Collaboration Agreement with Templar Chambers, one of the largest law firms in Guyana, providing additional coverage for the organization’s Caribbean platform. The full-service law firm was founded in 2004 and provides legal expertise across a wide spectrum of practice areas including banking and finance, corporate, contract and commercial, energy, mining, oil and gas, real estate, litigation as well as intellectual property. The firm brings in a highly experienced team of four attorneys and seven staff members, providing services to local and international clients doing business in Guyana. “Our firm is proud of the key role that we play in supporting Guyana’s development by helping new business enterprises grow and international companies enter the Guyanese market,” Office Managing Partner Glenn Hanoman said. “As one of Guyana’s leading commercial and business law firms, we are committed to providing our clients with best-in-class solutions. Our values and vis
Airship’s Data Study of Nearly 750 Million Individual App Users Finds Mobile App Engagement Rates Have Soared Under Lockdown29.9.2020 15:00:00 CEST | Press release
Customer engagement company Airship today revealed top-level results of its global benchmark study, examining the state of mobile app behaviors across nearly 750 million people worldwide. To distinguish between the impact of the pandemic and longer-term changes due to growing data regulations, more stringent app review policies by Apple and Google and ongoing evolution in user behavior, February 2020 was used for year-over-year analysis and then compared to March-June 2020. The full report is available for download here. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200929005324/en/ From February 2019 to February 2020, all regions saw average direct app opens (when a user opens an app from a click on a web or push notification) per user per month decline. March-June 2020 reversed this trend with all but one region seeing growth. (Graphic: Business Wire) Key findings show that the global pandemic led to massive gains for sev
Cat Rock Capital Issues Presentation on Just Eat Takeaway.com Merger with Grubhub29.9.2020 14:58:00 CEST | Press release
Cat Rock Capital Management LP (together with its affiliates, “Cat Rock Capital”), a long-term oriented investment firm and beneficial owner of approximately 6.8 million shares of the common stock of Just Eat Takeaway.com NV (“Just Eat Takeaway.com”, “JET”, or the “Company”) (LSE: JET), representing circa 4.5% of Just Eat Takeaway.com’s outstanding shares, today released a public presentation on the Just Eat Takeaway.com offer for Grubhub Inc. (“Grubhub”). This presentation can be found at JustEatDoesDeliver.com and is also available upon request via email@example.com. Alex Captain, Founder and Managing Partner, Cat Rock Capital Management LP, commented: “Cat Rock has been a shareholder of Just Eat Takeaway.com NV (“JET” or “the Company”) and its predecessor companies for over three years, and our firm has intensively researched the global online food delivery sector for over five years. We have developed a great respect for CEO Jitse Groen, his team, and his strategy over that time.
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