CHESTERBROOK, PA — Trevena, Inc. (NASDAQ: TRVN) announced the successful completion of its first-time-in-human Phase 1 study of TRV250, a biased delta receptor agonist that the Company is developing for the treatment of acute migraine. Preclinical data suggested that the novel selective signaling mechanism of TRV250 might avoid the seizure liability that has limited development of therapeutics targeting the delta receptor. Data from this healthy volunteer study showed safety, tolerability, and pharmacokinetics supporting the advancement of TRV250 to Phase 2 proof of concept evaluation in patients.
Key findings of the study were as follows:
- Dose-related increases in plasma concentrations following subcutaneous administration of doses up to 30 mg, with rapid absorption in the first hour and duration of exposure appropriate for treating acute migraine;
- Subcutaneous doses at and above 9 mg achieved plasma concentrations that were active in preclinical models of migraine;
- Oral bioavailability similar to existing migraine medications, supporting continued development of TRV250 in oral and/or subcutaneous formulations;
- No observed drug-associated EEG changes, consistent with preclinical studies in which TRV250 avoided the seizure liability associated with previous CNS-active delta receptor agonists; and
- No clinically significant changes in vital signs, laboratory values, or ECG parameters, and no severe or serious adverse events reported.
“We are pleased that TRV250 continues to show great potential for the treatment of acute migraine,” said Maxine Gowen, President & CEO. “Even as the treatment landscape for chronic migraine has evolved, there remains an important unmet need for patients who continue to suffer acute migraines and cannot achieve relief with currently available options. With the exposures reached in this study without associated EEG changes, TRV250 may finally unlock the delta receptor as a therapeutic target, and we look forward to laying the groundwork for a future Phase 2 trial with this novel molecule.”
Source: Trevena, Inc., 955 Chesterbrook Blvd, Suite 200, Chesterbrook PA 19087
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