Trevena, Inc. Announces Presentations Highlighting Novel S1P1 Receptor Modulator at the American College of Neuropsychopharmacology 59th Annual Meeting

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Presentations highlight efficacy of TRV045 in animal models of neuropathic pain and epilepsy

TRV045 selectively targets the S1P₁ receptor without associated lymphopenia

IND filing on track for 1H 2021

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CHESTERBROOK, Pa., Dec. 10, 2020 (GLOBE NEWSWIRE) — 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 two presentations at the 59^th Annual Meeting for the American College of Neuropsychopharmacology (ACNP). The conference was held virtually from December 6^th to 9^th, 2020.

The presentations included two posters, both of which discussed the potential utility of TRV045 to treat a variety of CNS disorders, including epilepsy, chemotherapy-induced peripheral neuropathy (CIPN), and diabetic peripheral neuropathy (DPN). The Company is currently collaborating with the National Institutes of Health (NIH) to evaluate TRV045 in their screening programs for epilepsy and non-addictive treatment of pain.

“These are compelling nonclinical findings for TRV045 and support its potential application in the treatment of epilepsy and neuropathic pain. We look forward to continuing to investigate the potential of TRV045 as a treatment for these debilitating disorders,” said Mark Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena, Inc.

Poster Details

1. “TRV045, a novel, selective S1PR₁ modulator, is efficacious in reversing neuropathic pain without affecting lymphocyte trafficking” (Poster #T125)
   • TRV045 demonstrated efficacy comparable to fingolimod, an approved S1P receptor modulator, in a mouse CIPN model. Unlike fingolimod, TRV045 did not cause lymphopenia at therapeutic doses.
   • TRV045 demonstrated efficacy comparable to gabapentin, an approved anticonvulsant medication sometimes used to treat diabetic neuropathy, in a rat diabetic peripheral neuropathy model. The Company believes this is the first time that modulation of the S1P₁ receptor has been shown to have potential therapeutic benefit in reversing diabetic neuropathic pain.
2. “TRV045, a novel, selective S1P1 receptor modulator that is not an immunosuppressant, is efficacious in rodent models of epilepsy” (Poster #W105)
   • TRV045 was evaluated as a potential anti-epileptic treatment in four well-established rodent seizure models, as part of the NIH’s Epilepsy Therapy Screening Program (ETSP).
   • TRV045 demonstrated a dose-dependent seizure prevention response in three of the models.
   • TRV045 does not cause lymphopenia at therapeutic doses, suggesting it may offer unique therapeutic benefits in a variety of CNS indications, including epilepsy, where immunosuppression is not desirable. Notably, fingolimod has also shown efficacy in rodent epilepsy models, but with substantial immunosuppression.

All posters can be found at https://www.trevena.com/publications.

About TRV045

Trevena is currently developing a novel sphingosine-1-phosphate (S1P) receptor modulator, TRV045, as a non-opioid treatment for various CNS disorders. S1P receptors are located throughout the body, including the central nervous system, where they are believed to play a role in modulating neurotransmission and membrane excitability. TRV045 is a preclinical, investigational drug candidate that engages the S1P receptor in a more selective manner that does not produce immunosuppression or alter lymphocyte trafficking. In a preclinical model of neuropathic pain, TRV045 demonstrated activity with no lymphopenia at therapeutic doses. The National Institutes of Health are currently evaluating TRV045 as a potential treatment for epilepsy and as a potential non-addictive treatment for acute / chronic pain.

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 one approved product in the United States, OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

For more information, please visit www.Trevena.com 

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 and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “objective,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “ongoing,” or the negative of these terms or 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 commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company’s clinical trials or any future trials of any of the Company’s investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company’s assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company’s intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates; 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.

This press release is not sanctioned by the ACNP.

For more information, please contact:

Investor Contact:

Dan Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com
(617) 430-7576

Company Contact:

Bob Yoder
SVP and Chief Commercial Officer
Trevena, Inc.
(610) 354-8840