Trevena Announces Advancement of TRV045 Into Clinical Development for Diabetic Neuropathic Pain
3-part randomized, double-blind, placebo-controlled Phase 1 study will evaluate TRV045 safety, tolerability, and PK in healthy volunteers
Enrollment expected to start in early Q1 2022
CHESTERBROOK, Pa., Dec. 13, 2021 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced it is advancing TRV045 into clinical development, following receipt of a notification from the U.S. Food and Drug Administration (FDA) that the study may proceed. TRV045 is the Company’s novel S1P1 receptor modulator being developed as a potential treatment for diabetic neuropathic pain (DNP). In addition, through a collaboration with the National Institutes of Health, the Company is also exploring TRV045 as a potential treatment for epilepsy.
“I am very pleased to have crossed this important milestone for the TRV045 development program and look forward to beginning our evaluation of this exciting molecule in the clinic,” said Carrie Bourdow, President and CEO of Trevena. “DNP is a painful condition that affects over 5 million people in the U.S., and currently available therapies are associated with both efficacy and tolerability concerns. TRV045 represents a potentially new approach to treating this burdensome condition, with an innovative mechanism of action at the S1P receptor.”
The Company will initiate a three-part Phase 1 single ascending dose (SAD), food effect, and multiple ascending dose (MAD) trial. The primary objective of the study is to evaluate the safety and tolerability of TRV045 in healthy adult subjects. The study will also assess the pharmacokinetics (PK) of TRV045 and determine whether TRV045 is associated with changes in lymphocyte counts, hemodynamic function, and QTcF interval.
In nonclinical studies, TRV045 was not associated with lymphopenia and produced no changes in blood pressure, heart rate, or respiratory function at or above pharmacologically active doses, unlike existing S1P receptor modulators, which are currently only approved by the FDA to treat multiple sclerosis and in one instance to treat moderately to severely active ulcerative colitis in adults. To date, there have been no head-to-head clinical studies of TRV045 compared to existing S1P receptor modulators.
Overview of the TRV045 Phase 1 Clinical Program
This will be a three-part randomized, double-blinded, placebo-controlled study in healthy volunteers. Part 1 of the study will investigate single ascending doses of TRV045 or placebo administered orally in up to 6 cohorts. Part 2 will investigate the effect of a high-fat meal on the safety, tolerability, and relative bioavailability of TRV045 in a single cohort. Part 3 will investigate multiple doses of TRV045 or placebo in up to 3 cohorts in order to obtain safety, tolerability, and PK (including dose proportionality) data under multiple-dosing conditions.
About Diabetic Neuropathic Pain
Diabetic neuropathy is a common complication of both type 1 and type 2 diabetes, with pain in the extremities being one of the main symptoms. Other symptoms may include numbness, tingling, allodynia and hyperalgesia. Diabetic neuropathic pain is usually characterized as moderate to severe in nature and can substantially affect patients’ quality of life as well as their social and psychological well-being.
Approximately 25% of people with diabetes are affected by DNP, equaling over 5 million people in the U.S. During their lifetime, approximately 50% to 70% of diabetic patients may experience symptoms of DNP.
TRV045 is a novel, selective sphingosine-1-phosphate subtype 1 (S1P1) receptor modulator being developed as a potential treatment for acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy. Through a collaboration with the National Institutes of Health, Trevena is also exploring TRV045 as a potential treatment for epilepsy.
S1P receptors are located throughout the body, including the central nervous system, where they are believed to play a role in modulating neurotransmission and membrane excitability.
Trevena's discovery efforts have identified a family of compounds that are highly selective for the S1P1 receptor. TRV045 reversed thermal hyperalgesia, a measure of neuropathic pain, in nonclinical models of diabetic peripheral neuropathy and chemotherapy-induced peripheral neuropathy. TRV045 was not associated with lymphopenia and produced no changes in blood pressure, heart rate, or respiratory function at or above pharmacologically active doses in nonclinical studies.
Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK® (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company’s novel pipeline is based on Nobel Prize winning research and includes four differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, TRV045 for diabetic neuropathic pain and epilepsy, and TRV027 for acute respiratory distress syndrome and abnormal blood clotting in COVID-19 patients.
For more information, please visit www.Trevena.com
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Released December 13, 2021