Trevena Announces Presentations at PAINWeek® 2015
– Four Posters Highlighting Data from TRV130, TRV734 and TRV250 Programs and an Oral Presentation on TRV130 –
KING OF PRUSSIA, Pa.--(BUSINESS WIRE)-- Trevena, Inc. (NASDAQ:TRVN), a clinical stage pharmaceutical company focused on the discovery and development of biased ligands targeting G protein coupled receptors (GPCRs), today announced that the Company will present four posters at PAINWeek®, the National Conference on Pain for Frontline Practitioners, being held at The Cosmopolitan Las Vegas, in Las Vegas, NV from September 8 – 12, 2015. The poster presentations highlight data from the Phase 2a/b trial of TRV130 in postoperative pain following bunionectomy surgery, Phase 1 data for oral TRV734 for acute and chronic pain (2 posters), and preclinical data for TRV250, an oral delta receptor biased ligand in development for the treatment of migraine.
The TRV130 bunionectomy trial abstract was selected for an oral presentation, which will be given by Franck Skobieranda, MD, vice president of clinical development at Trevena, in a session from 7:00 – 7:55 AM PDT on Friday September 11 in Gracia 5.
The posters will be available for viewing in Gracia 7 at The Cosmopolitan Las Vegas during the meeting and Dr. Skobieranda and Dr. Michael Lark, Trevena’s chief scientific officer, will be available to discuss the posters during the Poster Reception on Thursday, September 10, from 7:00 pm - 9:00 pm PDT.
“The scientific and clinical research presented at PAINWeek highlights our pipeline of differentiated pain therapies that we believe have the potential to provide relief to patients with fewer of the drawbacks of current therapies,” stated David Soergel, MD, chief medical officer at Trevena. “The data presented for TRV130 and TRV734 provide continued evidence of analgesic efficacy with a favorable tolerability profile compared to conventional opioids. The data for TRV250 also shows promise as a potential new class of therapy in the treatment of migraines and other CNS disorders with a novel mechanism of action.”
Details for the poster presentations at PAINWeek are as follows:
|TRV130, a G Protein-biased Ligand of the μ-opioid Receptor, Demonstrates Analgesic Efficacy Following Bunionectomy in
|an Adaptive Phase 2 Study (Abstract #0566)
|TRV734, a G Protein-biased Ligand of the μ-opioid Receptor, Demonstrates Oral Bioavailability, Displays
Predictable Pharmacokinetics and Pharmacodynamics, and Provides Analgesia in Healthy Adults (Abstract #0567)
|Formulation and Food Effect Studies of TRV734, an Oral, G Protein-biased Ligand of the μ-opioid Receptor (Abstract #0568)
|TRV250, a Novel G Protein-biased Ligand at the Delta Receptor for the Potential Treatment of Migraine (Abstract #0583)
Downloadable copies of the posters are available on the Trevena website: View posters.
TRV130 was designed to optimize opioid receptor pharmacology to deliver an improved analgesic profile. TRV130 is a biased mu-opioid receptor ligand which in preclinical studies activated analgesic signals while avoiding signals that can interfere with analgesia and promote respiratory depression and gastrointestinal dysfunction. In August 2015, the Company reported data from a Phase 2b trial comparing TRV130 to placebo and morphine following abdominoplasty surgery using on-demand patient-controlled analgesia (PCA). In this trial, TRV130 demonstrated similar efficacy to a standard regimen of morphine, with significantly less nausea, vomiting, and hypoventilation – a measure of respiratory safety. Previous clinical trials showed that TRV130 can deliver profound levels of pain relief safely and rapidly compared to i.v. morphine, and that doses of TRV130 that are more effective than morphine simultaneously depress respiratory drive to a lesser degree than morphine. Trevena believes that TRV130 may have an improved profile compared to currently used opioid analgesics and could offer enhanced pain relief more safely and with a reduced burden of opioid-related adverse events. Trevena anticipates that the initial market opportunity for TRV130 will be in the acute care settings, with a focus on moderate to severe acute pain in the hospital.
TRV734 is being developed to optimize analgesia while minimizing on-target gastrointestinal and central nervous system adverse effects through its novel mode of action at the mu-opioid receptor. TRV734 takes advantage of the same novel biased ligand mechanism at the mu-opioid receptor as TRV130, the company’s Phase 2 intravenous clinical candidate which has shown promising differentiation versus morphine.
TRV250 is an oral delta receptor biased ligand with promise as a migraine therapy, with a potential first-in-class mechanism that may benefit patients who cannot tolerate or do not benefit from triptan drugs. TRV250 may also have utility in a range of other CNS indications, and targets a receptor that is not associated with the addiction liability of mu opioid drugs like morphine or oxycodone.
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. Using its proprietary product platform, Trevena is developing four biased ligand product candidates it has identified – TRV027 to treat acute heart failure (Phase 2b), TRV130 to treat moderate to severe acute pain intravenously (completed Phase 2), TRV734 to treat moderate to severe acute and chronic pain orally (Phase 1), and TRV250 for acute episodic migraine and other CNS disorders (preclinical).
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, including the Company’s interpretation of the efficacy, safety and tolerability results from the studies above; 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, including with respect to whether the results of the Phase 2b study of TRV130 as well as prior clinical studies of this molecule will be consistent with the results obtained in any future Phase 3 studies; 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 viability or commercial potential of the company’s therapeutic candidates; the inherent uncertainties associated with intellectual property; 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.
Jonathan Violin, 610-354-8840 x231
Director of Investor Relations
Andrea Rabney, 212-600-1902
President and Chief Executive Officer
Eliza Schleifstein, 917-763-8106
Source: Trevena, Inc.
Released September 8, 2015