Recursion’s Phase 2 Trial for the Treatment of Cerebral Cavernous Malformation has Fully Enrolled
13 Junho 2023 - 9:00AM
Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company
decoding biology to industrialize drug discovery, today announced
the full enrollment of its Phase 2 SYCAMORE clinical trial
evaluating REC-994, a potentially first-in-class, orally
bioavailable small molecule for the treatment of CCM.
"We are encouraged by the full enrollment of our Phase 2 trial
ahead of schedule," said Recursion’s Chief Medical Officer, David
Mauro, M.D, Ph.D. "We are pleased with the continued enthusiasm and
support of the patient community and to see patients enroll in the
long term extension study."
The Phase 2 trial is designed as a multi-center, randomized,
double-blind, placebo-controlled study to investigate the safety,
efficacy and pharmacokinetics of REC-994. The primary outcome is
specific to safety and tolerability, measured by adverse events.
The secondary outcomes center on efficacy, including clinician- and
patient-reported outcomes, imaging of CCM lesions (number, size
& rate of change), the impact of acute stroke, as well as
exploratory biomarkers.
About REC-994
REC-994 is an orally bioavailable small molecule superoxide
scavenger being developed for the treatment of CCM. In Phase 1
single ascending dose, or SAD, and multiple ascending dose, or MAD,
trials in healthy volunteers that Recursion conducted, REC-994
demonstrated tolerability and suitability for chronic dosing.
REC-994 has been granted Orphan Drug designation for CCM by the
U.S. Food and Drug Administration and the European Commission.
About Cerebral Cavernous Malformation
CCM is a neurovascular disease caused by inherited or somatic
mutations in any of three genes involved in endothelial function:
CCM1, CCM2, or CCM3. Approximately 360,000 patients in the United
States and EU5 are impacted by symptomatic CCM, where approximately
20% of patients have a familial form of CCM that is inherited in an
autosomal dominant pattern, leading to multigenerational disease
that is extremely impactful for affected families. Moreover,
approximately 25% of individuals diagnosed with CCM are children.
CCM manifests as vascular malformations of the spinal cord and
brain that put affected patients at substantial risk for seizures,
headaches, progressive neurological deficits and disabling and
potentially fatal hemorrhagic strokes. Current non-pharmacologic
treatments include microsurgical resection and stereotactic
radiosurgery, though not all patients and lesions can be treated
with these methods, and rebleeds and other side effects limit the
effectiveness of these interventions. There is no approved
pharmacological treatment that affects the rate of growth of CCM
lesions or their propensity to bleed or otherwise induce
symptoms.
About Recursion
Recursion 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 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.
Media Contact
Media@Recursion.com
Investor Contact
Investor@Recursion.com
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