Trevena, Inc. (NASDAQ: TRVN), a clinical-stage pharmaceutical company and leader in the discovery and development of G protein coupled receptor (GPCR) biased ligands, today announced the initiation of its first Phase 1 trial for TRV734, a novel drug candidate in development as an orally administered treatment for moderate to severe acute and chronic pain. TRV734 is being developed to optimize analgesia while minimizing on-target gastrointestinal and respiratory effects through its novel biased ligand mechanism at the mu-opioid receptor. TRV734 takes advantage of the same receptor specificity mechanism as does Trevena’s Phase 2 clinical candidate, TRV130, an intravenous mu-opioid G protein biased ligand being developed for acute postoperative pain.
"With a targeted mechanism of action giving the potential to mitigate a number of dose-limiting side effects associated with current opioid treatments, we believe TRV734 holds great promise as a novel analgesic," stated David Soergel, M.D., senior vice president of clinical development at Trevena. "In preclinical studies, TRV734 demonstrated an encouraging therapeutic profile, with a potent analgesic effect and a reduced impact on gastrointestinal motility at equianalgesic doses compared to oxycodone. We look forward to further evaluating its potential in a clinical setting."
The main objective of this first-in-human trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of TRV734 in healthy subjects. The potentially efficacious dose range of TRV734 will also be evaluated using pupilometry, a validated biomarker for mu-opioid receptor engagement.
"The initiation of this trial represents another step in our continued progress towards translating our groundbreaking biased ligand technology into the next generation of G protein coupled receptor targeted medicines," stated Maxine Gowen, Ph.D., president and chief executive officer of Trevena. "With TRV734, we now have three clinical-stage drug candidates that we are developing to address significant unmet medical needs, and are focused on driving their development while continuing to pursue additional candidates identified with our ABLE™ platform."
Trevena, Inc. is a clinical stage biopharmaceutical company that discovers, develops and intends to commercialize therapeutics that use a novel approach to target G protein coupled receptors, or GPCRs. In addition to TRV734, Trevena has applied its proprietary ABLE™ drug discovery platform to identify and advance two other differentiated product candidates into the clinic; TRV027 to treat acute heart failure, and TRV130 to treat moderate to severe acute pain intravenously. Trevena also plans to advance additional preclinical product candidates derived from its platform.
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, its future operations, clinical development of its therapeutic candidates, its plans for potential future product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "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: availability and timing of data from ongoing clinical trials, the uncertainties inherent in the initiation of future clinical trials, whether interim results from a clinical trial will be predictive of the final results of the trial or results of early clinical trials will be indicative of the results of future trials, expectations for regulatory approvals, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements, other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates and other factors discussed in the “Risk Factors” section of the Company’s final prospectus filed with the Securities and Exchange Commission on January 31, 2014 and other filings the Company makes with the Securities and Exchange Commission from time to time. In addition, the forward-looking statements included in this press release represent the Company’s views 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, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.
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