Trevena Announces TRV045 Presentation at the American College of Neuropsychopharmacology 62nd Annual Meeting

Trevena, Inc.

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Presentation highlighted promising results of TRV045 in nonclinical models of neuropathic pain including mechanical and cold-stimulus evoked nociceptive pain in a dose-related manner

TRV045 selectively targets the S1P₁ receptor without associated lymphopenia

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CHESTERBROOK, Pa., Dec. 04, 2023 (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 a poster presentation at the 62^nd Annual Meeting for the American College of Neuropsychopharmacology (ACNP). The conference is being held from December 3^rd to 6^th, 2023.

The poster discussed the potential utility of TRV045 for the treatment of chemotherapy-induced peripheral neuropathy (CIPN) using an established nonclinical model. CIPN is a nerve-damaging side effect of antineoplastic agents and occurs in approximately 70% of oncology patients undergoing chemotherapy. In addition, the Company is currently collaborating with the National Institutes of Health (NIH) to evaluate TRV045 for the potential treatment of epilepsy and as a nonopioid treatment for pain.

“These are compelling nonclinical findings for TRV045 that add to our growing understanding of its mechanism and the potential use in a range of CNS disorders, including neuropathic pain,” said Mark Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena, Inc.

Presentation Details

Presentation Title: “TRV045, a novel and selective S1P1 receptor modulator is efficacious in acute, chronic and prevention modes in mouse models of chronic neuropathy, without causing lymphopenia”

• Overall. Oral administration of TRV045 reduced mechanical and cold stimulus-evoked nociception in a dose-related manner in a mouse model of CIPN.

• Acute Reversal (Single and Multiple-Dose). These effects were demonstrated in single-dose acute reversal and were sustained following repeated administration of TRV045 for 14 days; effects were evident at doses of 3mg/kg and 10mg/kg.

• CIPN Prevention. In a prevention mode paradigm examining the potential effect of TRV045 to prevent the development of CIPN, TRV045 administered at 100mg/kg reduced both mechanical and cold hypersensitivity 24 hours following the last dose, and this reduction in cold hypersensitivity was present at seven days after the last dose of TRV045, suggesting a potential disease or pathology-modifying effect on pain transmission processes detectable by the cold hypersensitivity test.
  

About TRV045

TRV045 is a novel, selective sphingosine-1-phosphate subtype 1 (S1P₁) receptor modulator being developed as a potential treatment for acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy. Through a collaboration with the National Institutes of Health, Trevena is also exploring TRV045 as a potential treatment for epilepsy.

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.

Trevena's discovery efforts have identified a family of compounds that are highly selective for the S1P₁ receptor. TRV045 reversed thermal hyperalgesia, a measure of neuropathic pain, in nonclinical models of diabetic peripheral neuropathy and chemotherapy-induced peripheral neuropathy. TRV045 was not associated with lymphopenia and produced no changes in blood pressure, heart rate, or respiratory function at or above pharmacologically active doses in nonclinical studies. TRV045 is an investigational product and is not yet approved by the FDA.

About Trevena

Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative 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’s novel pipeline is based on Nobel Prize winning research and includes three differentiated investigational drug candidates: TRV045 for diabetic neuropathic pain and epilepsy, TRV250 for the acute treatment of migraine and TRV734 for maintenance treatment of opioid use disorder.

For more information, please visit www.Trevena.com

About Chemotherapy-induced Peripheral Neuropathy (CIPN)

Chemotherapy-induced peripheral neuropathy (CIPN) is a nerve-damaging side effect of antineoplastic agents in chemotherapy. Approximately 70%¹ of oncology patients treated with chemotherapy experience CIPN. Antineoplastic agents in chemotherapy are designed to eliminate rapidly dividing cancer cells as part of their therapeutic effect. However, they can also damage healthy structures, including the peripheral nervous system². Patients with CIPN experience a range of symptoms such as tingling, pain, and numbness in the hands and feet³. These symptoms may impact daily living activities, reduce balance, and increase the risk of falls and hospitalizations.

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; 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