EQS-News : Relief Therapeutics and NeuroRx Meet 165 Patient Enrollment Target in Phase 2b/3 Trial of RLF-100(TM) for Critical COVID-19 with Respiratory Failure

 
 EQS Group-News: RELIEF THERAPEUTICS Holdings AG / Key word(s): Study 
Relief Therapeutics and NeuroRx Meet 165 Patient Enrollment Target in Phase 
2b/3 Trial of RLF-100(TM) for Critical COVID-19 with Respiratory Failure 
 
2020-12-07 / 07:00 
 
*Relief Therapeutics and NeuroRx Meet 165 Patient Enrollment Target in Phase 
2b/3 Trial of RLF-100(TM) for Critical COVID-19 with Respiratory Failure* 
 
*Geneva, Switzerland and Radnor, Pa, USA, December 7, 2020 -* RELIEF 
THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) ("*Relief*" or the 
"*Company*") and NeuroRx, Inc. today announced that they have met the 165 
patient enrollment target agreed with the U.S. Food and Drug Administration 
(FDA) in the ongoing phase 2b/3 trial of RLF-100(TM) (aviptadil) for 
treating Respiratory Failure in patients with Critical COVID-19. Respiratory 
Failure is defined, according to the FDA, as the need for intensive care 
with mechanical ventilation, non-invasive ventilation, or high-flow nasal 
oxygen in order to sustain adequate levels of blood oxygen. 
 
"Although enrollment has been uniquely challenged by the devastating effects 
of the pandemic, straining the capacity of hospitals and exposing our 
investigators and study coordinators to personal peril from COVID-19 in the 
course of their duties, we are proud to meet our enrollment target as 
planned," said *Prof. Jonathan Javitt, CEO and founder of NeuroRx, Inc. 
*"Achieving this milestone in the midst of the pandemic has only been 
possible because of the extraordinary dedication of the doctors, nurses, 
pharmacists, and study coordinators who continued to work around the clock 
to develop this much-needed therapy." 
 
There is currently no FDA-approved drug that has shown efficacy in patients 
who are already in the Intensive Care Unit (ICU) with Respiratory Failure. 
In addition to the ongoing phase 2b/3 trial, more than 200 patients with 
Critical COVID-19 and respiratory failure have been treated in an 
FDA-approved, Expanded Access Protocol (EAP) for RLF-100(TM). These patients 
were unable to enter the phase 2b/3 randomized trial due to severe 
comorbidities (such as organ transplant, recent heart attack, or cancer). 
While the companies have focused first on those patients who have no medical 
alternative and are at immediate risk of death, a phase 2b/3 trial with 
RLF-100(TM) for inhaled use in patients with moderate and severe COVID-19 in 
order to prevent progression to respiratory failure is expected to start 
soon. 
 
Although the phase 2b/3 study will remain blinded until the final patients 
reach day 28, unexpected rapid recovery on chest X-ray has been reported by 
study sites and frequently reported in the open-label Expanded Access 
Protocol as well. In the EAP, of the 90 patients who have reached 28 days 
post-treatment, 72% have survived to day 28. The clinical trial will 
continue to enroll patients through the anticipated early Q1 2021 
announcement of top line data in order to amass as large a safety database 
as possible. 
 
To date, no drug-related Serious Adverse Event has been reported in any of 
the ongoing studies of RLF-100(TM), which is consistent with the absence of 
toxicity seen in extensive nonclinical safety testing and prior human 
studies. 
 
### 
 
*ABOUT VIP in COVID-19* 
 
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 (ATII), that is critical to transmission of oxygen 
to the body. 
 
COVID-19-related respiratory failure is caused by selective infection of the 
ATII cell by the SARS-CoV-2 virus. They are vulnerable because of their 
(ACE2) surface receptors, which serve as the route of entry for the virus. 
These specialized cells manufacture surfactant that coats the lung and is 
essential for oxygen exchange. Loss of surfactant causes collapse of the air 
sacs (alveolae) in the lung and results in respiratory failure. 
 
VIP is shown to block Coronavirus replication in the ATII cell, block 
cytokine synthesis, block viral-induced cell death (cytopathy), and 
upregulate surfactant production. Other than RLF-100(TM), no currently 
proposed treatments for COVID-19 specifically target these vulnerable Type 
II cells. 
 
*ABOUT RLF-100(TM)* 
 
RLF-100(TM) (Aviptadil) is a formulation of Vasoactive Intestinal 
Polypeptide (VIP) that was developed based on Prof. Sami Said's original 
work at Stony Brook University, for which Stony Brook was awarded an FDA 
Orphan Drug Designation in 2001. VIP is known to be highly concentrated in 
the lungs, where it inhibits coronavirus replication, blocks the formation 
of inflammatory cytokines, prevents cell death, and upregulates the 
production of surfactant. FDA has now granted IND authorization for 
intravenous and inhaled delivery of RLF-100(TM) for the treatment of 
COVID-19 and awarded Fast Track designation. RLF-100(TM) is being 
investigated in two placebo-controlled US phase 2b/3 clinical trials in 
respiratory deficiency due to COVID-19. Since July 2020, more than 300 
patients with Critical COVID-19 and Respiratory Failure have been treated 
with RLF-100(TM) between the two FDA-approved protocols (randomized and 
expanded access). Information on the RLF-100(TM) Expanded Access program is 
at https://www.neurorxpharma.com/our-services/rlf-100 [1]. 
 
*ABOUT RELIEF* 
 
Relief focuses primarily on clinical-stage programs 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. Its lead drug candidate RLF-100TM 
(aviptadil), synthetic vasoactive intestinal peptide (VIP), is being 
investigated in two placebo-controlled U.S. phase 2b/3 clinical trials in 
respiratory deficiency due to COVID-19. RLF-100TM is believed to be the 
first COVID-19 therapeutic to demonstrate the ability to block replication 
of the SARS-CoV-2 virus in human lung cells and monocytes, while also 
preventing synthesis of cytokines in the lung. Since July 2020, severe 
COVID-19 patients have been treated with RLF-100TM under U.S. FDA Emergency 
Use Investigational New Drug (IND) authorization and Expanded Access 
Protocol authorization for the treatment of respiratory failure in COVID-19. 
Relief also holds a patent issued in the United States and various other 
countries covering potential formulations of RLF-100TM. 
 
RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the 
symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. 
 
Follow us on *LinkedIn [2].* 
 
*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(TM), 
NeuroRx has been awarded Breakthrough Therapy Designation and a Special 
Protocol Agreement to develop NRX-101 in suicidal bipolar depression and is 
currently in Phase 3 trials. Its executive team is led by Prof. Jonathan C. 
Javitt, MD, MPH, who has served as a health advisor to four Presidential 
administrations and worked on paradigm-changing drug development projects 
for Merck, Allergan, Pharmacia, Pfizer, Novartis, and Mannkind, together 
with Robert Besthof, MIM, who served as the Global Vice President 
(Commercial) for Pfizer's Neuroscience and Pain Division. 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. 
 
*CORPORATE CONTACT                   *NeuroRx, Inc.* 
RELIEF THERAPEUTICS Holding AG*      Jonathan C. Javitt, M.D., 
Raghuram (Ram) Selvaraju, Ph.D., MBA MPH 
Chairman of the Board                Chairman and Chief 
Mail: [e-mail] Executive Officer 
www.relieftherapeutics.com           Mail: [e-mail] 
*MEDIA CONTACT: 
Relief (Europe)*                     *NeuroRx (United States)* 
MC Services AG                       David Schull 
Anne Hennecke / Brittney Sojeva      Russo Partners, LLC 
Tel.: [phone]         Tel.: [phone] 
Mail: [e-mail] [3]      Mail: 
                                     david.schull@russopartnersl 
                                     lc.com 
*INVESTOR RELATIONS                  *NeuroRx (United States)* 
Relief (Europe)*                     Brian Korb 
MC Services AG                       Solebury Trout 
Anne Hennecke / Brittney Sojeva      Tel.: [phone] 
Tel.: [phone]         Mail: [e-mail] 
Mail: [e-mail] [3] 
 
Disclaimer: This communication expressly or implicitly contains certain 
forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, 
NeuroRx, Inc. and their businesses. The results reported herein may or may 
not be indicative of the results of future and larger clinical trials for 
RLF-100(TM) for the treatment of COVID-19. 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 

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December 07, 2020 01:00 ET (06:00 GMT)