Recursion Announces Completion of Phase 1 Study for REC-3964 for Clostridioides Difficile Infection
05 Setembro 2023 - 8:59AM
Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company
decoding biology to industrialize drug discovery, today announced
it has completed the Phase 1 study for REC-3964 in healthy
volunteers. The study achieved its primary objectives of assessing
the safety, tolerability and pharmacokinetic profile of REC-3964.
REC-3964 has been well tolerated with no serious adverse events
(SAEs) reported.
“This is an important step in our efforts to rapidly translate
our first new chemical entity into a safe and effective therapy
that has the potential to address a significant unmet need,” said
David Mauro, M.D., Ph.D., Chief Medical Officer of Recursion. “We
are encouraged by the strong safety and tolerability profile and
are actively exploring the most expeditious path to advance this
program to patients.”
REC-3964 is a novel non-antibiotic small molecule inhibitor of
C. difficile toxins that is being developed for the potential
treatment of Clostridioides difficile (C. diff) infection, a
bacterial disease that impacts more than 730,000 people in the US
and EU5 every year. REC-3964 is Recursion’s first and most advanced
new chemical entity, demonstrating the power of Recursion’s
platform to rapidly identify, validate, optimize and translate
novel insights into clinical candidates.
REC-3964 represents a novel small molecule approach designed to
selectively inhibit the toxin produced by Clostridioides 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. More than 29,000 patients die
in the US every year from C. diff infection.
About the Trial The Phase 1 study was
designed as a first-in-human protocol evaluating single and
multiple doses of orally administered REC-3964 in healthy
volunteers. The study assessed the safety, tolerability and
pharmacokinetic (PK) profile of REC-3964 and consisted of two
parts: single ascending dose (SAD) and multiple ascending dose
(MAD). Dosing levels for MAD were 100 mg (Cohort 1), 300 mg (Cohort
2), 500 mg (Cohort 3), and 900 mg (Cohort 4). In Cohort 1, 12
participants were randomized to receive either REC-3964 (N=10) or
placebo (N=2) and in each Cohorts 2 through 4, 10 participants were
randomized to receive either REC-3964 (N=8) or placebo (N=2) for a
total of 42 participants for the MAD study. Participants were dosed
with REC-3964 for 14 days.
PK analysis demonstrated that exposures (AUC) increased
approximately dose-proportionally across the dose ranges tested and
the half-life ranged from approximately 7 to 10 hours. As a result,
twice-daily (BID) dosing is expected to reach targeted trough
concentrations. Overall, REC-3964 was very well tolerated. Four
participants (11.8%, N=34) experienced treatment-related adverse
events, which were mild. Additionally, no treatment-related SAEs
were observed, and there were no discontinuations due to a
treatment-related adverse event. Based on these data, a Phase 2
proof-of-concept trial is expected to initiate in 2024 to further
study the attributes of this molecule.
About RecursionRecursion (NASDAQ: RXRX) is a
clinical stage TechBio company leading the space by decoding
biology to industrialize drug discovery. 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, Montréal and the
San Francisco Bay Area. Learn more at www.Recursion.com, or connect
on Twitter and LinkedIn.
Forward-Looking StatementsThis 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 REC-3964 and other 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; 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.
Media Contact
Media@Recursion.com
Investor Contact
Investor@Recursion.com
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