- Recursion initiates TUPELO, a Phase 2 trial of REC-4881 for the
potential treatment of Familial Adenomatous Polyposis (FAP)
- Recursion initiates a Phase 1 trial for the potential treatment
of Clostridium difficile (C. diff) Colitis with Recursion's first
new chemical entity to enter the clinic
SALT
LAKE CITY, Sept. 13, 2022 /PRNewswire/ -- Recursion
(NASDAQ: RXRX), the clinical-stage biotechnology company
industrializing drug discovery by decoding biology, today announced
the initiation of two additional clinical trials including
its first in-house generated new chemical entity to enter the
clinic. Recursion has now initiated a total of four clinical trials
in 2022; three Phase 2 or 2/3 proof-of-concept studies and one
Phase 1 study.
![Recursion Logo (PRNewsfoto/Recursion) Recursion Logo (PRNewsfoto/Recursion)](https://mma.prnewswire.com/media/1440500/Recursion_Logo_2020_Black_Logo.jpg)
"In a challenging year for the biotech industry, Recursion has
continued to deliver on its goals and mission to decode biology to
radically improve lives," said Chris
Gibson, Ph.D., CEO and Co-Founder of Recursion. "Our teams
have worked tirelessly to advance our first new chemical entity
into a first-in-human study and deliver on our goals, initiating
four new clinical trials this year. These include initiating a
Phase 2 trial for cerebral cavernous malformation (CCM) in March, a
Phase 2/3 trial for neurofibromatosis type 2 (NF2)-mutated
meningiomas in June, and now our Phase 2 trial for FAP and Phase 1
trial for C. diff."
About the Phase 2 Trial of REC-4881 for FAP
The Phase 2 TUPELO clinical trial is evaluating REC-4881 for the
potential treatment of familial adenomatous polyposis (FAP) in
patients who have previously undergone a colectomy/proctocolectomy.
REC-4881 is an orally bioavailable, non-ATP-competitive allosteric
small molecule inhibitor of MEK1 and MEK2 being developed to reduce
polyp burden and progression to adenocarcinoma in people living
with FAP. It has been granted Fast Track and Orphan Drug
designations for the potential treatment of FAP by the U.S. Food
and Drug Administration as well as Orphan Drug designation by the
European Commission.
There are currently no FDA-approved therapies for the treatment
of FAP, a rare tumor predisposition syndrome affecting
approximately 50,000 people in the US, France, Germany, Italy, Spain
and the UK. Recursion discovered REC-4881 as a potential candidate
for treatment of FAP by leveraging its proprietary AI-powered drug
discovery platform, the Recursion OS, against cellular models of
loss of function of the APC gene. Mutations in the
APC gene lead to FAP. The company believes its approach, in
which machine learning is used to identify relationships between
biological contexts and chemical entities, enables Recursion to
accelerate the drug discovery process and expand the scope of
potential therapeutic candidates for numerous diseases.
"Despite progress with surgical management, the need for
effective therapies for FAP remains high due to continued risk of
tumors post-surgery," said Niloy Jewel
Samadder, M.D., Professor of Medicine at Mayo Clinic,
Enterprise Co-Director, Office of Individualized/Precision
Medicine, Mayo Clinic Comprehensive Cancer Center. "The initiation
of the TUPELO trial is an important step toward potential treatment
options to reduce or eliminate the burden of this devastating
disease."
The TUPELO Phase 2 trial is a multicenter, randomized,
double-blind, placebo-controlled two-part clinical trial to
evaluate efficacy, safety, and pharmacokinetics of REC-4881 in
patients with FAP.
About the Phase 1 Trial of REC-3964 for Clostridium Difficile
Infection
Recursion today announced the initiation of its Phase 1 clinical
trial evaluating REC-3964 in healthy volunteers. REC-3964 is a
novel non-antibiotic small molecule inhibitor of C.
difficile toxins which is being developed for the potential
treatment of Clostridium difficile infection, a bacterial disease
that impacts more than 730,000 people in the US and EU5 every year.
It is the first new chemical entity discovered by the Recursion OS
to enter clinical trials.
Recursion discovered REC-3964 using its proprietary AI-powered
drug discovery platform, the Recursion OS, in which machine
learning is used to identify relationships between biological
contexts and chemical entities. REC-3964 represents a novel small
molecule approach designed to selectively inhibit the toxin
produced by Clostridium difficile in the gastrointestinal tract.
This molecule has the potential, when used as part of a treatment
regimen, to prevent recurrent disease and/or other forms of C. diff
infection, which is a leading cause of antibiotic-induced diarrhea
sometimes leading to significant morbidity and mortality.
"Initiating this trial is a significant milestone for Recursion,
as it represents the progression and maturation of our clinical
pipeline to include new chemical entities – illustrating the power
of our Recursion OS platform to not only uncover novel biological
insights, but also help optimize and test novel chemical compounds
for potential use as therapeutics," said Shafique Virani, Chief Business Officer and
Interim Chief Medical Officer at Recursion. "We are encouraged by
the preclinical data from this program and look forward to
advancing it rapidly through clinical studies."
The Phase 1 study is a first-in-human protocol evaluating single
and multiple doses of REC-3964 in healthy volunteers. The study
will assess the safety, tolerability and pharmacokinetic profile of
REC-3964 and will provide the basis for establishing the
therapeutic potential of this novel C. difficile antitoxin
agent.
For more information about enrollment in these trials, please
contact clinicaltrials@recursion.com.
About Recursion
Recursion is a
clinical-stage biotechnology company industrializing drug discovery
by decoding biology. Enabling its mission is the Recursion OS, a
platform built across diverse technologies that continuously
expands one of the world's largest proprietary biological and
chemical datasets. Recursion leverages sophisticated
machine-learning algorithms to distill from its dataset a
collection of trillions of searchable relationships across biology
and chemistry unconstrained by human bias. By commanding massive
experimental scale — up to millions of wet lab experiments weekly —
and massive computational scale — owning and operating one of the
most powerful supercomputers in the world, Recursion is uniting
technology, biology and chemistry to advance the future of
medicine.
Recursion is headquartered in Salt
Lake City, where it is a founding member of BioHive, the
Utah life sciences industry
collective. Recursion also has offices in Toronto, Montreal and the San
Francisco Bay Area. Learn more at www.Recursion.com, or
connect on Twitter and LinkedIn.
Media Contact
Media@Recursion.com
Investor
Contact
Investor@Recursion.com
Forward-Looking Statements
This document contains
information that includes or is based upon "forward-looking
statements" within the meaning of the Securities Litigation Reform
Act of 1995, including, without limitation, those regarding early
and late stage discovery, preclinical, and clinical programs;
licenses and collaborations; prospective products and their
potential future indications and market opportunities; the
Recursion OS and other technologies; business and financial plans
and performance; and all other statements that are not historical
facts. Forward-looking statements may or may not include
identifying words such as "plan," "will," "expect," "anticipate,"
"intend," "believe," "potential," "continue," and similar terms.
These statements are subject to known or unknown risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied in such statements, including but
not limited to: challenges inherent in pharmaceutical research and
development, including the timing and results of preclinical and
clinical programs, where the risk of failure is high and failure
can occur at any stage prior to or after regulatory approval due to
lack of sufficient efficacy, safety considerations, or other
factors; our ability to leverage and enhance our drug discovery
platform; our ability to obtain financing for development
activities and other corporate purposes; the success of our
collaboration activities; our ability to obtain regulatory approval
of, and ultimately commercialize, drug candidates; the impact of
the COVID-19 pandemic and force majeure events; our ability to
obtain, maintain, and enforce intellectual property protections;
cyberattacks or other disruptions to our technology systems; our
ability to attract, motivate, and retain key employees and manage
our growth; and other risks and uncertainties such as those
described under the heading "Risk Factors" in our filings with the
U.S. Securities and Exchange Commission, including our most recent
Quarterly Report on Form 10-Q and our Annual Report on Form 10-K.
All forward-looking statements are based on management's current
estimates, projections, and assumptions, and Recursion undertakes
no obligation to correct or update any such statements, whether as
a result of new information, future developments, or otherwise,
except to the extent required by applicable law.
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