ZURICH, March 26, 2020 /PRNewswire/ -- RELIEF
THERAPEUTICS Holding AG (SIX: RLF) "Relief", together with
NeuroRx, a Delaware Corporation, have filed an Investigational New
Drug (IND) Application with the US FDA for a phase 2 trial of
RLF-100 (Aviptadil) in the treatment of Acute and Moderate
Respiratory Distress in patients infected by the COVID-19
coronavirus. NeuroRx, Inc. is a privately held, drug development
company that has previously demonstrated success in developing
innovative drugs under FDA Fast Track, Breakthrough Therapy, and
Special Protocol Agreement programs. Relief previously partnered
with Biogen to develop Aviptadil for the treatment of pulmonary
hypertension.
"In a previous trial of VIP for ARDS caused by 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. and Vice Chairman[1] nominee of Relief.
"Patients on ventilators for COVID-19 have only a 50% chance of
survival and 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. Should this trial demonstrate efficacy, Relief
Therapeutics has sufficient immediately shippable drug substance to
treat more than 100,000 Americans."
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. At an FDA public hearing in
2016[2], it was noted that more than 8,000 prescriptions
for VIP were filled by a compounding pharmacy to treat a chronic
inflammatory condition without any reported adverse events.
Relief Therapeutics holds FDA orphan drug designations for the
use of VIP to treat ARDS, pulmonary hypertension, and
sarcoidosis. Relief also holds a US patent[3] for
Aviptadil and proprietary manufacturing processes for its
synthesis.
"Humanity is threatened by a deadly virus that has
demonstrated a propensity to cause lethal ARDS. Conventional forms
for respiratory support have so far failed to preserve life in half
of those who develop ARDS in the setting of COVID-19
infection," commented Dr. Raghuram (Ram) Selvaraju, PhD, MBA,
Chairman of Relief. "We are cautiously optimistic that the early
observations wherein RLF-100 7 of 8 patients with sepsis-related
ARDS will carry over to today's crisis."
www.relieftherapeutics.com
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] Pending election at the upcoming General Assembly of Relief
Shareholders
[2] FDA Pharmacy Compounding Advisory Committee, November 3, 2016
[3] US 8,178,489 Formulation for Aviptadil
CONTACT:
Media
Robert
Besthof
Chief Commercial
Officer
NeuroRx,
Inc.
+14842546134 ext
701
rbesthof@neurorxpharma.com
Investor Relations
Brian Korb
Solebury Trout
+1-917-653-5122
bkorb@troutgroup.com
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content:http://www.prnewswire.com/news-releases/relief-therapeutics-and-neurorx-inc-file-fda-ind-for-aviptadil-to-treat-covid-19-induced-respiratory-distress-301030267.html
SOURCE NeuroRx