EQS Group-News: RELIEF THERAPEUTICS Holdings AG / Key word(s): Study results 
Correction: NeuroRx and Relief announce initial successful results from 
expanded access use of RLF-100(TM) (aviptadil) in patients with Critical 
COVID-19 and Severe Comorbidity: 72% survival seen in ICU patients 
 
2020-11-25 / 18:27 
 
*Correction: NeuroRx and Relief announce initial successful results from 
expanded access use of RLF-100(TM) (aviptadil) in patients with Critical 
COVID-19 and Severe Comorbidity: 72% survival seen in ICU patients* 
 
*Correction of the press release published November 24, 2020: It has come to 
our attention that a mistake was printed in the percentage of control 
patients in the EAP who survived to day 28. The correct percentage is 27%, 
not 17% of the control patients, all treated with best available intensive 
care unit (ICU) Standard of Care, survived to day 28. This has been 
corrected in the text below. * 
 
*Geneva, Switzerland and Radnor, PA, November 25, 2020 -* RELIEF 
THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) ("*Relief*" or the 
"*Company*") and NeuroRx, Inc., announced that more than 175 patients with 
Critical COVID-19 and Respiratory Failure who also have a severe comorbidity 
have now been entered into an Expanded Access Protocol (EAP) with 
RLF-100(TM) in the United States. 
 
All patients had severe comorbidities (such as organ transplant, recent 
heart attack, and cancer) that rendered them ineligible for the ongoing 
randomized, controlled phase 2b/3 trial being conducted to ascertain safety 
and efficacy of RLF-100(TM), and all patients were deteriorating despite 
treatment with approved therapies for COVID-19 (see www.clinicaltrials.gov 
NCT 04311697 [1]). Of the 90 patients who have so far reached 28 days of 
follow-up, 72% survived to day 28. 
 
As previously reported by Youssef and coworkers 
(http://dx.doi.org/10.2139/ssrn.3665228 [2]), at Houston Methodist Hospital, 
21 patients treated with RLF-100(TM) under the EAP were compared to 24 
control patients treated in the same setting. Only 27% of the control 
patients, all treated with best available intensive care unit (ICU) Standard 
of Care, survived to day 28. The survival rate with RLF-100(TM) reported 
today is comparable to that seen among the open-label patients treated with 
RLF-100(TM) by Youssef et al. Despite advancements in treating COVID-19, 
survival for the patients at highest risk due to severe comorbidities has 
remained dismal in the absence of an effective therapy. 
 
Notably, in the EAP, no drug-related Serious Adverse Events have been 
reported to date among these patients nor the 160 patients randomized to 
RLF-100(TM) vs. placebo in the U.S. phase 2b/3 clinical trial currently 
underway. Thus, from a risk/benefit perspective, while the benefit of 
RLF-100(TM) has not yet been proven in a randomized prospective trial, no 
serious risk has been identified so far. 
 
Currently, 25 U.S. hospitals have enrolled patients in the EAP, nearly all 
of which are community hospitals, suggesting that RLF-100(TM) can 
demonstrate effectiveness in the hands of front-line physicians who deliver 
the majority of care to patients with Critical COVID-19. Physicians 
enrolling patients in the EAP have routinely reported that initial patients 
at their sites have frequently been in the ICU for several weeks without 
recovery prior to treatment with RLF-100(TM). As patients are treated 
earlier in the course of their ICU stay, there is an emerging clinical 
impression that RLF-100(TM) has an even greater impact on recovery. 
 
"We are reassured that emerging real-world data on the use of RLF-100(TM) in 
improving survival in patients with Critical COVID-19 are comparable to 
results seen in the hands of major academic teaching centers. We hope that 
these findings are viewed as encouraging at a time when many Americans, 
including the doctors, nurses, and other front-line caregivers who are the 
heart of our initiative, are celebrating the Thanksgiving holiday at a 
distance from their loved ones. We look forward to completing enrollment and 
reporting the results of our pivotal U.S. clinical trial," said *Prof. 
Jonathan C. Javitt, MD, MPH, CEO and founder of NeuroRx, Inc.* 
 
### 
 
*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 2 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 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. 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 are 
essential for oxygen exchange. Other than RLF-100(TM), no currently proposed 
treatments for COVID-19 specifically target these vulnerable type 2 cells. 
 
*ABOUT RLF-100(TM)* 
RLF-100(TM) (Aviptadil) is a formulation of Vasoactive Intestinal 
Polypeptide (VIP) that was developed based on Dr. 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 150 patients with Critical 
COVID-19 and Respiratory Failure have been treated with RLF-100(TM) under 
FDA-approved protocols. Information on the RLF-100(TM) Expanded Access 
program is at https://www.neurorxpharma.com/our-services/rlf-100 [3]. 
 
*ABOUT RELIEF THERAPEUTICS HOLDING AG* 
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. Relief holds orphan drug designations from 
the U.S. FDA and the European Union for the use of VIP to treat ARDS, 
pulmonary hypertension, and sarcoidosis. Relief also holds a patent issued 
in the U.S. and multiple other countries covering potential formulations of 
RLF-100(TM). 
 
RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the 
symbol RLF and quoted in the U.S. on the OTCQB under the symbol RLFTF. 
 
*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. 
 
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 
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 

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November 25, 2020 12:27 ET (17:27 GMT)