Trevena, Inc. ( TRVN Quick Quote TRVN - Free Report) announced that it is advancing its novel S1P receptor modulator, TRV045 into clinical development as a potential treatment for diabetic neuropathic pain (DNP). The company decided to begin clinical studies on TRV045 after it received a notification from the FDA that the study may proceed.
The company will initiate a three-part double-blind, placebo-controlled phase I study, which will evaluate the safety and tolerability of TRV045 in healthy adults. The study will also investigate the pharmacokinetics (PK) of TRV045 and determine whether the candidate is related to changes in lymphocyte counts, hemodynamic function, and QTcF interval.
The company plans to begin enrollment in the study early in the first quarter of 2022.
Per the company, part 1 of the study will evaluate single ascending doses of TRV045 or placebo while part 2 will evaluate the effect of a high-fat meal on the safety, tolerability, and relative bioavailability of TRV045. Part 3 will investigate multiple doses of TRV045 or placebo in up to three cohorts in order to obtain safety, tolerability, and PK data under multiple-dosing conditions.
Shares of Trevena have declined 67.5% so far this year compared with the
industry’s decrease of 22.8%. Image Source: Zacks Investment Research
We remind investors that in September 2021, the company had submitted an investigational new drug (IND) application for TRV045 to begin clinical studies on the same. However, the FDA issued a clinical hold letter regarding certain phase I study design elements. Trevena responded to the regulatory body’s comments and refiled the IND for TRV045 to treat DNP.
The company is also looking to study TRV045 as a potential treatment for epilepsy.
Please note that Trevena’s sole marketed product Olinvyk (oliceridine) injection is approved in the United States for the management of acute pain in adults severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.
The company also has a portfolio of novel pipeline candidates, which are being developed for various types of central nervous system disorders. Apart from TRV045, Trevena is developing TRV250 for the acute treatment of migraine, TRV734 for moderate-to-severe acute and chronic pain as well as opioid use disorders and TRV027 for acute respiratory distress syndrome and abnormal blood clotting in patients with COVID-19 infection.
Zacks Rank & Stocks to Consider
Trevena currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include
Sarepta Therapeutics, Inc. ( SRPT Quick Quote SRPT - Free Report) , Editas Medicine, Inc. ( EDIT Quick Quote EDIT - Free Report) and vTv Therapeutics Inc. ( VTVT Quick Quote VTVT - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
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