Business Wire

Relief Therapeutics (RLF:SIX) Drug Aviptadil Enters FDA Trial at University of Miami, to Treat COVID-19-induced Respiratory Distress

Share

RELIEF THERAPEUTICS Holding AG (SIX:RLF) “Relief” announces that its drug Aviptadil has now entered FDA clinical trials at the University of Miami Miller School of Medicine for the treatment of Acute Respiratory Distress Syndrome (ARDS) in COVID-19. The trial will enroll patients who are already on mechanical ventilation in the hopes that Aviptadil can decrease mortality in this condition and help to improve the ability of the patient’s lung to transfer oxygen to the body.

The trial is being led by Relief’s US partner, NeuroRx, Inc., Headquartered in Radnor, PA under FDA Investigational New Drug clearance, as part of the FDA’s Corona Treatment Acceleration Program (CTAP). Details are posted on clinicaltrials.gov NCT04311697. The principal investigator for the University of Miami study site is Dr. Dushyantha Jayaweera, professor of medicine. The Co-Principal Investigators are Dr. Daniel H. Kett, professor of medicine, and Dr. Daniel Dante Yeh, associate professor of surgery at the University of Miami Miller School of Medicine. The team will also collaborate with colleagues at the UM Interdisciplinary Stem Cell Institute.

We are fortunate to have widespread support and collaboration across our institution,” said Dr. Jayaweera. “As we follow rigorous scientific standards, we are cautiously optimistic that the early observations of VIP use in patients with sepsis-related ARDS will carry over to today’s crisis.

Death in COVID-19-infected patients is caused by a “cytokine storm” in the lungs, in which the virus triggers inflammatory molecules called “cytokines,” which cause the air sacs (alveolae) of the lungs to fill with water and become impermeable to oxygen, even in the setting of mechanical ventilation. VIP is a naturally synthesized peptide which is 40% concentrated in the lungs and which has been shown to have a potent anti-cytokine activity in numerous animal models of respiratory distress, acute lung injury, and inflammation. It has a 20-year history of safe use in human beings in multiple human trials for sarcoidosis, pulmonary fibrosis, and pulmonary hypertension, and is marketed in Europe as a local injection to treat erectile dysfunction.

Relief Therapeutics holds FDA and EU orphan drug designations for the use of VIP to treat ARDS, pulmonary hypertension, and sarcoidosis. Relief also holds a US patent1 for Aviptadil and proprietary manufacturing processes for its synthesis.

“In a previous trial of VIP for ARDS in patients with sepsis, 7 of 8 patients on mechanical ventilation showed substantial improvement and 6 ultimately left the hospital alive,” said Prof. Jonathan Javitt, MD, MPH, the CEO of NeuroRx, Inc.. “Patients on ventilators for COVID-19 have only a 50% chance of survival. If the early results can be replicated in ARDS caused by COVID-19, this treatment could have a major impact both on COVID-19 survival and on the availability of ventilators for those in desperate need.”

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.

About RLF-100

RLF-100 (Aviptadil) is a patented formulation of Vasoactive Intestinal Polypeptide (VIP) that was originally developed and is currently marketed in Europe for the treatment of erectile dysfunction. VIP is known to be highly concentrated in the lung and to inhibit a variety of inflammatory cytokines. Aviptadil was awarded Orphan Drug Designation in 2001 by the US FDA for treatment of Acute Respiratory Distress Syndrome and in 2005 for treatment of Pulmonary Arterial Hypertension. Aviptadil 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 US FDA and the EMEA have granted Investigational New Drug licenses for human trials of Aviptadil.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF.

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

Contact information

Yves Sagot
contact@relieftherapeutics.com

About Business Wire

Business Wire
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

Closer Collaboration between the EUIPO and EURid to Benefit SMEs25.5.2020 13:30:00 CESTPress release

The European Union Intellectual Property Office (EUIPO) and EURid, the domain name registry for the .eu, .ею and .ευ top-level domains, are set to intensify collaboration to support trade mark and domain name applicants and owners, particularly small and medium enterprises (SMEs). This collaboration will support users of the EU IP system, particularly startups, by helping them to obtain trade mark and domain name protection in a joined-up manner, so they can secure their brands from the very beginning of their business journey. At present, EU trade mark applicants are advised whether their trade mark is available as a .eu domain name at the end of the online application process at EUIPO. Applicants and holders can also set up alerts to be informed once a .eu domain name that matches their trade mark is registered. Under a new work programme agreed jointly by the two organisations, the EUIPO and EURid will explore the possibility of implementing a reciprocal process when a .eu domain na

TIP Trailer Services Announces Appointment of New CFO25.5.2020 10:05:00 CESTPress release

TIP Trailer Services, a portfolio company of I Squared Capital, has appointed Hans van Lierop as Chief Financial Officer and management board member. Hans started as CFO for TIP from Monday, 18th of May 2020 and is based in TIP’s international headquarters in Amsterdam, the Netherlands. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200525005042/en/ Hans van Lierop, appointed CFO of TIP Trailer Services (Photo: Business Wire) “I am looking forward to joining TIP’s senior leadership team and leading its Finance organisation and look forward to contributing to TIPs future success. ” Hans van Lierop commented. Hans van Lierop joins TIP with broad international experience from different industries in Europe and Africa. He has held financial leadership roles in Diageo, Airtel and Massmart Walmart. Most recently, Hans Van Lierop was CFO of Massmart Walmart, a South African retail and wholesale distributor with a turnover of US$ 7

Teva Presented New Data at the European Academy of Neurology Congress Evaluating the AJOVY ® (fremanezumab) Experience in Populations with Difficult-to-Treat Migraine25.5.2020 08:00:00 CESTPress release

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) presented a wide range of important new data on AJOVY® (fremanezumab) and the societal and economic impact of migraine in Europe at the 6th Congress of the European Academy of Neurology (EAN). This year’s EAN congress was a virtual meeting due to the global coronavirus pandemic. The fremanezumab data included pooled analyses of the AJOVY Phase 3 clinical trials (FOCUS, HALO-episodic migraine (EM) and HALO-chronic migraine (CM)) which focused on the safety, efficacy and improved quality-of-life for patients experiencing difficult-to-treat migraine. Post-hoc analyses were also evaluated in patients who may experience challenges when managing their migraine due to comorbidities. Migraine creates a significant disease and economic burden. With more than one billion people impacted globallyi, migraine is the second leading global cause of years lived with disabilityii and annual costs of the disease in the U.S. and EU are $200 billio

JEOL: Release of a New Schottky Field Emission Scanning Electron Microscope JSM-IT80025.5.2020 08:00:00 CESTPress release

JEOL Ltd. (TOKYO:6951) (President & COO Izumi Oi) announces the release of a new Schottky field emission scanning electron microscope, JSM-IT800 in May 2020. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200524005002/en/ JSM-IT800 (Photo: Business Wire) Development Background Scanning electron microscopes (SEMs) are used in various fields, such as nanotechnology, metals, semiconductors, ceramics, medicine, and biology. As SEM applications are expanding from research and development to quality control and product inspection at manufacturing sites, SEM users are in need of faster high-quality data acquisition and simple compositional information confirmation with seamless operation. To meet these demands, the JSM-IT800, with the Intelligence Technology (IT) platform, incorporates our In-lens Schottky Plus field emission electron gun for high resolution imaging to fast elemental mapping, and an innovative electron optical cont

Ipsen: New Surveys Show Over 80% of Patients with Spasticity and Cervical Dystonia Treated with Botulinum Toxin-A Experience Debilitating Symptom Recurrence23.5.2020 07:00:00 CESTPress release

Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today presents the results of two patient surveys. The surveys involved over 400 respondents from five countries, living with spasticity or cervical dystonia and receiving botulinum neurotoxin type A (BoNT-A) injections. The results show that over 80% of respondents experienced debilitating symptom recurrence, and revealed that a lack of long-lasting symptom control between injections has a profound impact on the personal and professional lives of patients.1-4 “The results from these two important patient surveys provide significant insight into the real-life burden of the two conditions; however, they also highlight a worrying disconnect between patients’ treatment expectations and their actual experience. The findings, which build on our growing understanding of spasticity and cervical dystonia, provide us with the potential to unlock meaningful changes in clinical practice,” said Dr Alberto Esquenazi, Department of Physical Medicine

U.S. FDA Approves Takeda’s ALUNBRIG ® (brigatinib) as a First-Line Treatment Option for Patients Diagnosed with Rare and Serious Form of Lung Cancer22.5.2020 22:30:00 CESTPress release

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) approved ALUNBRIG (brigatinib) for adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. This approval expands ALUNBRIG’s current indication to include the first-line setting. ALUNBRIG is a potent and selective next-generation tyrosine kinase inhibitor (TKI) designed to target ALK molecular alterations. “We’re extremely proud of the positive results ALUNBRIG has shown for newly diagnosed ALK+ NSCLC patients, particularly those with brain metastases,” said Teresa Bitetti, President, Global Oncology Business Unit, Takeda. “Through a robust clinical development program and ongoing investigations across the NSCLC treatment landscape, Takeda is committed to uncovering solutions for people living with devastating forms of lung cancer in need of new options. We believe this approva

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