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Trevena Reports Full Year 2014 Financial Results
- On Track to Report Phase 2 Data for TRV130 in Soft-Tissue Surgery Patients in Mid-2015 -
- Phase 2b BLAST-AHF Trial of TRV027 in Acute Heart Failure Expanded -
- Company to Host Conference Call at 8:30 AM EDT Today -
KING OF PRUSSIA, PA, March 18, 2015 Trevena, Inc. (NASDAQ: TRVN), a clinical stage biopharmaceutical company focused on the discovery and development of G protein coupled receptor (GPCR) biased ligands, today announced financial results for the fourth quarter and year ended December 31, 2014.
In 2014, Trevena made outstanding progress across all areas of our business and we are now well positioned to advance our clinical pipeline this year as we look to initiate the Companys first Phase 3 study in 2016, said Maxine Gowen, Ph.D., chief executive officer. The results of our Phase 2a/b study of TRV130 in postoperative pain support its potential to provide more powerful pain relief than may be achievable with currently used opioids, with an encouraging safety and tolerability profile. We are on track to complete our ongoing Phase 2b soft-tissue surgery trial and are continuing to plan for the Phase 3 program. For TRV027, we launched a large-scale, well-designed Phase 2b study in acute heart failure at the beginning of 2014. We have completed the pre-specified interim analysis and recently announced additional funding of $10 million from Actavis to expand the number of patients in this study. Finally, we rapidly advanced oral TRV734 through two Phase 1 studies, and recently added a preclinical delta receptor compound, TRV250, to our pipeline.
Recent Corporate Highlights
CNS Programs (TRV130, TRV734, and TRV250)
· Announced positive results from a phase 2a/b study of TRV130 in acute postoperative pain following bunionectomy surgery. In November 2014, the Company announced positive top-line data from its randomized, double-blind, placebo- and active-controlled Phase 2a/b trial of TRV130 in moderate-to-severe acute postoperative pain. Over the 48 hour study period, 3 mg TRV130 every 3 hours showed statistically superior analgesic efficacy compared to 4 mg morphine every four hours. Additionally, in the first 3 hours of dosing, when pain was most severe, the 2 mg and 3 mg doses of TRV130 demonstrated statistically superior analgesic efficacy compared to 4 mg morphine. At these doses, trends in respiratory depression favored TRV130 versus morphine. Overall tolerability of 2 mg TRV130 was similar to morphine and at lower TRV130 doses, there was a trend toward improved tolerability.
· Initiated a phase 2b study of TRV130 for acute postoperative pain following soft tissue surgery. In January 2015, Trevena initiated a 200-patient Phase 2b clinical trial of TRV130 for acute postoperative pain in patients following abdominoplasty surgery. This study uses patient-controlled analgesia to allow patients to optimally treat their pain. The Company expects to report top-line results from this trial in mid-2015.
· Reported positive phase 1 data for TRV734. In February 2015, Trevena reported data from a Phase 1 multiple ascending dose trial of TRV734 showing pharmacokinetics, safety, tolerability, and CNS activity consistent with that found in a previous Phase 1 study and supporting further study in Phase 2. The recently completed Phase 1 study used an experimental pain model in
The following information was filed by Trevena Inc (TRVN) on Wednesday, March 18, 2015 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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