Safety, tolerability, and PK profile support potential utility as a novel acute migraine treatment option
CHESTERBROOK, Pa., Dec. 12, 2019 (GLOBE NEWSWIRE) -- Trevena, Inc. (TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced a poster presentation at the 58th Annual Meeting of the American College of Neuropsychopharmacology (ACNP), in Orlando, FL. The poster presentation featured results from a Phase 1 first-in-human study that evaluated the safety, tolerability, and pharmacokinetics (PK) of TRV250, the Company’s novel G protein-selective delta-receptor agonist being developed for the acute treatment of migraine.
TRV250 was well-tolerated up to 30 mg, with a PK profile appropriate for an acute migraine therapy. There were no serious adverse events and no clinically significant changes in EEG, ECG, or other safety parameters.
“We are excited to be pursuing TRV250 as a potential new therapeutic option for migraine sufferers, many of whom struggle to achieve relief with currently available options,” said Mark A. Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena, Inc. “The positive data from this Phase 1 study informed our recently initiated proof-of-concept study, with topline data anticipated in the second half of next year.”
Poster Presentation Details
- Poster presentation (#142): “A Phase 1 Healthy Volunteer Study of the Safety, Tolerability and Pharmacokinetics of TRV250, a G Protein-Selective Delta Receptor Agonist”, Wednesday, Dec. 11th, 5:00-7:00 p.m. EDT
TRV250 is a G protein biased ligand targeting the delta receptor, with potential to be a first-in-class, non-narcotic mechanism for the treatment of migraine. TRV250 also may have utility in a range of other central nervous system indications. As a selective delta receptor modulator, TRV250 is not expected to have the abuse and addiction liability of medications targeting the mu opioid receptor. TRV250 is an investigational product and has not been approved by FDA for distribution in the US.
Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has four novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to managing chronic pain.
Cautionary note on forward looking statements
Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development of its therapeutic candidates, plans for potential future product candidates and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company’s clinical trials; the uncertainties inherent in conducting clinical trials; expectations for regulatory approvals; availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; uncertainties related to the Company’s intellectual property; other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time-to-time.
In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.
This press release is not sanctioned by ACNP.
For more information, please contact:
Bob Yoder, SVP and Chief Business Officer