Business Wire

NeuroRx and Relief Therapeutics Announce Fast Track Designation Granted by the FDA to RLF-100 (Aviptadil) for the Treatment of Respiratory Distress in COVID-19

Share

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.

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

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

Takeda Presents New Data Highlighting Scientific Advancements in Lung Cancer at ESMO Virtual Congress18.9.2020 12:55:00 CESTPress release

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the company is presenting data from its lung cancer portfolio at the virtual European Society for Medical Oncology (ESMO) conference. Notably, insights from sub-analyses of the Phase 3 ALTA 1L study reinforce both the compelling evidence of intracranial efficacy with ALUNBRIG® (brigatinib) as a first-line treatment for patients with anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) as well as associated quality of life (QoL) data. Takeda is also featuring updated 10-month follow-up results from the Phase 1/2 trial of mobocertinib (TAK-788), demonstrating mobocertinib achieved a duration of response (DoR) of more than one year in the trial’s study population of patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ metastatic NSCLC (mNSCLC). “We’re pleased to present our ongoing research in lung cancer at this year’s virtual ESMO congress, including new

Incyte Announces Encouraging Results From Phase 2 Trial of Retifanlimab (INCMGA0012) in Patients With Previously Treated, Advanced Squamous Cell Carcinoma of the Anal Canal18.9.2020 12:00:00 CESTPress release

Incyte (Nasdaq:INCY) today announced results from its Phase 2 POD1UM-202 trial evaluating retifanlimab, a PD-1 inhibitor, in previously treated patients with advanced squamous cell carcinoma of the anal canal (SCAC) who have progressed following standard platinum-based chemotherapy. The trial enrolled 94 patients, including those with well-controlled human immunodeficiency virus (HIV) infection (10%). Retifanlimab monotherapy resulted in a confirmed objective response rate (ORR) of 14% as determined by independent central review (ICR) using RECIST v1.1. Responses were observed regardless of PD-L1 status, presence of liver metastases, age or HIV+ status. Retifanlimab was generally well-tolerated with a safety profile as expected of a PD-1 inhibitor and no loss of HIV infection control. Key findings from POD1UM-202: N=94 ORR* (95% CI) 13.8% (7.6-22.5) Best OR*, n 1 CR 12 PR 33 SD DCR 48.9% DOR, median (95% CI), months 9.5 (5.6-NE) PFS, median (95% CI), months 2.3 (1.9-3.6) OS, median (95

Sigfox and Cube Infrastructure Managers Announce Major Partnership in IoT Infrastructure18.9.2020 09:30:00 CESTPress release

Sigfox, the global 0G network1 and cloud provider for industrial data, is proud to announce a new strategic alliance with Cube Infrastructure Managers (Cube), through the sale of its German 0G network to Cube. Sigfox has grown its 0G IoT services by rolling out 0G networks across 72 countries and regions, which was largely achieved with partners called Sigfox Operators. These operators are the owners of the 0G networks, which they operate as exclusive connectivity providers of Sigfox IoT services, offering worldwide connectivity to customers. The sale of the German network to Cube will allow Sigfox to finance its continued innovation efforts in data value extraction and improvements in cloud algorithms to reduce energy consumption and allow the implementation of even more cost-effective devices and sensors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200918005116/en/ Cube Infrastructure Managers, the European infrastructu

Sensorion successfully raises approximately €31 (US$ 36.5) million in an oversubscribed private placement to US and European investors18.9.2020 08:00:00 CESTPress release

Regulatory News: Not for release, publication or distribution, directly or indirectly, in or into the United States, Canada, Australia or Japan. This press release is not intended as an offer and is for informational purpose only Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN – the “Company”) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders announces today the success of its previously announced capital increase. The Company has placed 18,236,000 new ordinary shares with a nominal value of €0.10 each (the “New Shares”), for total gross proceeds of approximately € 31 million by means of an accelerated bookbuild offering to the benefit of categories of persons (the “Reserved Offering”). The issue price of the New Shares is €1.70 per share, representing a 3.5% discount to the weighted average share price on the day preceding the date on which the issuance price

Vifor Pharma Group Announces Successful Sale of OM Pharma18.9.2020 07:00:00 CESTPress release

Regulatory News: Vifor Pharma has today announced the successful sale of 100% of the share capital of OM Pharma, a Vifor Pharma Group company to Optimus Holding Ltd. The terms of the deal include: A purchase consideration of MCHF 435 for 100% of the share capital An earn out related to potential future value gains on 20% of Optimus Holding Ltd. equity to be determined before the end of 2027 upon a trade sale, IPO or EBITDA multiple This earn out together with the purchase consideration could result in a total transaction value exceeding MCHF 500. The deal is expected to close within 30 days. OM Pharma is a Geneva-based company mainly active in the field of microbial derived immunotherapeutics and has developed strongly outside the core strategy of Vifor Pharma over the past few years. Optimus Holding Ltd. is a Swiss Group, founded by Etienne Jornod together with long-standing Swiss entrepreneurs and Abdi Ibrahim (28.5%), a Turkey-based pharmaceutical company operating in 12 countries a

ESMO 2020: Phase II CLARINET FORTE Results Show Increasing Dose Frequencies of Somatuline ® Autogel ® (lanreotide) Allows Patients with NETs to Delay Treatment Escalation by up to 8.3 Months18.9.2020 07:00:00 CESTPress release

Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today announced the release of first efficacy and safety data from the CLARINET FORTE study, with the abstract to be presented as a mini-oral presentation at the 2020 European Society for Medical Oncology (ESMO) Congress, taking place virtually from 19-21 September 2020. The prospective single-arm, open-label, exploratory, international Phase II study investigated the efficacy and safety of increasing the dose frequency of Somatuline® Autogel®(lanreotide) in patients with pancreatic or midgut NETs with centrally-assessed progression within the last two years while on a standard lanreotide regimen for ≥24 weeks. An extension of progression-free survival (PFS) rates and encouraging disease-control rates (DCR) were recorded in both tumor types, with no new safety signals. “These results support a clinically meaningful benefit to a population of patients with high unmet medical need by potentially delaying escalation to more toxic treatmen