Last week, the company, along with U.S. partner NeuroRx, met
the 165 patient enrollment target agreed with the U.S. Food and Drug
Administration in their ongoing phase 2b/3 trial of RLF-100, which is a
patented version of aviptadil.
Aviptadil is a synthetic formulation of a naturally
occurring peptide called Vasoactive Intestinal Polypeptide (VIP), which is
primarily concentrated in the lungs and works to reset the immune system
response along with serving as a vasodilator and boosting the production of surfactant
in the lungs, which enables blood oxygen transfer.
RLF-100 has been around since 2000, when it was developed to
treat acute respiratory distress and other lung conditions and subsequently
acquired by Biogen. Earlier this year, Relief scientists discovered that it
could protect the cell that is attacked by the Covid-19 virus.
Speaking to CNBC via telephone from New York, Relief
Therapeutics Chairman Ram Selvaraju said the ongoing trial is expected to
provide topline data in the first half of January, and attributed the meteoric
rise in the company’s share price in part to its evidence of efficacy in
“otherwise untreatable patients.”
“Where other people have focused primarily on mildly
infected or moderately infected people, we have fastidiously tried to see
whether our drug can bring benefits to the critically ill and the end-stage
folks,” he explained.
Early stage results from expanded access use of RLF-100 in
patients suffering with critical Covid-19 and severe comorbidities showed 72%
of those admitted into the ICU surviving.
Relief Therapeutics had a market cap of less than 100
million Swiss francs ($113 million) at the end of July, and on August 10
following promising results from the first 21 patients treated with RLF-100
under FDA Expanded Access Protocol authorization, it had surpassed 1.6 billion
Swiss. It has since leveled off to just under 1 billion Swiss francs.
The 38,000% increase figure largely represents the small
scale of the initial share price, which sat at just under 0.40 Swiss francs per
share as of Friday afternoon. In contrast, shares of multinational Roche are
worth 306 Swiss francs.
Other therapeutics being tested on patients more moderate
symptoms have been purchased by government agencies seeking to combat the
pandemic, with the U.S. government’s Operation Warp Speed placing orders for
Gilead’s remdesivir and Eli Lilly’s bamlanivimab.
Selvaraju revealed that Relief Therapeutics and NeuroRx had
been in contact with Operation Warp Speed and said if the drug successfully proves
its efficacy in seriously ill patients following phase three randomized
testing, the company expects to receive stockpiling orders on a similar scale
to the likes of Gilead and Eli Lilly. A spokesperson for the U.S. Department of
Health and Human Services was not immediately available for comment when
contacted by CNBC.
Covid the ‘tip of the iceberg’
In June, the FDA granted fast-track designation to RLF-100,
and it has also received orphan drug designation for the treatment of acute
respiratory distress syndrome (ARDS).
As the drug is not an antiviral designed specifically to
combat the coronavirus, Relief Therapeutics is hoping that the current pandemic
is “an opportunity for this drug to shine” if it is proven definitively to have
therapeutic clinical utility in addressing respiratory complications arising
from Covid-19.
“Covid-19 is really the tip of the iceberg, the head of the
spear. If we prove that this drug works in Covid-19 related respiratory
distress, then we anticipate that we would be able to leverage those results
into testing the drug further in other forms of acute respiratory distress
syndrome that has nothing to do with Covid-19,” Selvaraju said, adding that
this puts Relief Therapeutics in a “pretty unique position.”
“While a lot of other experimental therapeutics are going to
either live or die based on how the pandemic evolves, we feel on the contrary
that once we have established this drug’s therapeutic utility in the context of
Covid-19, hopefully, our long term vision is to have this drug become a sort of
workhorse drug for emergency rooms and Intensive Care Units and hospitals and
hospital systems everywhere.” - CNBC
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