Safety, tolerability, and PK profile support potential utility as a novel acute migraine treatment option

CHESTERBROOK, PA, USA I December 12, 2019 I 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 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 

About TRV250

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.

About Trevena

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.

SOURCE: Trevena