Centrexion Therapeutics Announces Issuance of U.S. Composition of Matter Patent for Lead Pipeline Candidate CNTX-4975
December 03 2019 - 8:00AM
Centrexion Therapeutics Corporation, a company focused on
developing non-opioid, non-addictive therapies for the treatment of
chronic pain, today announced that the U.S. Patent and Trademark
Office has issued a composition of matter patent (Patent No.
10,493,047) entitled “Stable Aqueous Capsaicin Injectable
Formulations and Medical Uses Thereof,” which provides coverage for
the formulation of capsaicin used in the company’s CNTX-4975
product candidate. The patent describes and claims an aqueous,
injectable, ready-to-use formulation of capsaicin.
CNTX-4975, the company’s lead product candidate, is an
investigational synthetic, proprietary, ultra-pure intra-articular
injection of a selective TRPV1 agonist (capsaicin) currently in
pivotal clinical trials for the treatment of moderate-to-severe
pain associated with knee osteoarthritis (OA).
“We are extremely pleased with the issuance of this patent for
CNTX-4975 that supports the easy-to-use, room temperature-stable,
prefilled syringe for administration, and believe it is an
important milestone for Centrexion,” said Jeffrey B. Kindler, chief
executive officer of Centrexion Therapeutics. “As we complete our
pivotal clinical trials for CNTX-4975 for moderate-to-severe pain
associated with knee OA, this additional protection is an important
component in establishing a solid foundation for a successful
commercialization plan.”
CNTX-4975 is designed to be administered directly into the joint
(intra-articular [IA]) where the pain stimulus originates, and to
selectively and locally target and disrupt the signaling of
specific TRPV1 pain-signaling nerve fibers within the joint. In
January 2018, CNTX-4975 was granted Fast Track designation by the
U.S. Food and Drug Administration for the treatment of
moderate-to-severe pain associated with knee OA. Centrexion has
completed patient enrollment in all three studies comprising the
Phase 3 VICTORY clinical program and expects to report the results
of VICTORY-1 and VICTORY-3 in the first quarter of 2020. Centrexion
anticipates reporting the results of the second pivotal trial,
VICTORY-2, in the third quarter of 2020.
About the Phase 3 VICTORY ProgramThe Phase 3
VICTORY clinical program consists of three trials. VICTORY-1 and
VICTORY-2 are pivotal, randomized, double-blind,
placebo-controlled, 52-week clinical trials to evaluate the
efficacy and safety of intra-articular (IA) injections of CNTX-4975
in people with chronic, moderate-to-severe pain resulting from knee
osteoarthritis (OA). VICTORY-1 is a 332-patient, single IA dose
trial to evaluate a single injection of CNTX-4975. VICTORY-2 is a
331-patient trial that includes a repeat dose, administered six
months after the first IA injection. The primary endpoint of both
trials is the change in pain with walking measured at Week 12,
using the numeric pain rating scale (NPRS [0-10]). Secondary
endpoints at Week 12 include improvement in the average pain,
stiffness and function (subparts A, B and C of the Western Ontario
and McMaster Universities Osteoarthritis Index, WOMAC) measured at
Week 12. Additional secondary endpoints will be measured out to
week 52, including other variables such as patient global
impression of change (PGIC), functional outcomes, quality of life
measures and change in knee radiographs from baseline to Week
52.
VICTORY-3 trial is an open label, eight-week trial to evaluate
the tolerability of a single IA injection of 1.0 mg of CNTX-4975 in
856 patients with chronic moderate-to-severe pain resulting from
knee OA. In addition to expanding the safety database for
CNTX-4975, VICTORY-3 is evaluating three patient groups (single
painful knee, single painful knee with the opposite knee having a
joint replacement, and bilateral painful knee OA where both knees
are treated) as well as variations of the procedure pain control
technique designed to enable physicians to select options that
could best fit their practice dynamics and patient needs if
CNTX-4975 is approved.
Patients enrolled in the Phase 3 VICTORY program were permitted
to enter the trials on their oral standard of care analgesics for
their painful knee OA, such as NSAIDs and an opioid.
About Osteoarthritis Osteoarthritis (OA) is the
most common joint disease in the U.S., currently affecting more
than 30 million Americans, according to the U.S. Centers for
Disease Control. OA occurs when cartilage, the tissue that envelops
the structural bones within a joint, gradually deteriorates. These
changes cause pain, swelling and problems moving the joint.
Although OA can affect any joint, it most often affects joints in
the knees, hips, lower back and neck, small joints of the fingers
and the bases of the thumb and big toe. Over time, patients with
knee OA tend to become inactive due to pain and joint stiffness and
reduced function.
About CNTX-4975CNTX-4975, Centrexion’s most
advanced product candidate, is an investigational synthetic,
proprietary, ultra-pure intra-articular injection of a selective
TRPV1 agonist (capsaicin) for the treatment of moderate-to-severe
pain associated with knee OA. CNTX-4975 is designed to be
administered directly into the joint where the pain stimulus
originates and to selectively and locally target and disrupt the
signaling of TRPV1 pain-signaling nerve fibers. In January 2018,
CNTX-4975 was granted Fast Track Designation by the U.S. Food and
Drug Administration for the treatment of moderate-to-severe pain
associated with knee OA.
About Centrexion Therapeutics Corporation
Centrexion is a late clinical-stage biopharmaceutical company
focused on becoming the leader in identifying, developing and
commercializing novel, non-opioid and non-addictive therapies to
address the large unmet medical need for the treatment of chronic
pain.
Media ContactJulie Normart, W2O pure+1 (559)
974-3245jnormart@w2ogroup.com
Investor ContactCourtney Dugan, W2O pure+1
(212) 257-6723cdugan@w2ogroup.com
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