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Trevena Announces Initiation of TRV027 Study in COVID-19 Patients in Collaboration With Imperial College London

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TRV027 is a novel AT1 receptor selective agonist with the potential to treat acute lung damage / abnormal blood clotting associated with COVID-19

The Company expects to report topline data in Q1 2021

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CHESTERBROOK, Pa., Aug. 24, 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 Imperial College London (ICL) has initiated a proof-of-concept study for TRV027 in COVID-19 patients. Through an ongoing collaboration with ICL, the Company is evaluating the potential of TRV027 to treat acute lung damage / abnormal blood clotting associated with COVID-19. ICL is sponsoring and funding the study, with additional support through the British Heart Foundation Centre for Research Excellence Award.

“I am very pleased that Imperial College London has reached this important milestone of trial initiation,” said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc. “As the global search for solutions to combat the COVID-19 pandemic continues, there remains an urgent need for new therapies that can prevent the severe multi-organ damage caused by the virus. TRV027 represents a uniquely targeted approach to potentially treating some of the serious and deadly complications associated with COVID-19.”

In a COVID-19 infection, the SARS-coronavirus-2 binds to and removes the ACE2 protein in the lungs and other organs, resulting in a hormonal imbalance at the AT1 receptor. This results in acute lung damage, which often progresses to acute respiratory distress syndrome (ARDS), as well as abnormal blood clotting throughout the body. TRV027 specifically binds to and rebalances AT1 receptor activation, blocking the damaging pathway that leads to ARDS and abnormal blood clotting conditions such as stroke. Additionally, the unique mechanism of action of TRV027 selectively targets the reparative pathway that improves lung function and promotes anti-inflammatory effects.

This is a randomized, double-blind, placebo-controlled study that will enroll approximately 60 hospitalized, non-ventilated patients aged 18 or older with a confirmed COVID-19 infection. The primary objective of the study is to evaluate whether TRV027 reduces abnormal clotting associated with COVID-19. The study will also assess the effect of TRV027 on lung function and other clinical outcomes. The Company currently expects to report topline data in Q1 2021.

About TRV027

TRV027 is a novel AT1 receptor selective agonist that has previously been studied in 691 individuals. It has demonstrated efficacy, potency, and selectivity at the AT1 receptor in nonclinical studies and has a well-characterized pharmacokinetic profile. In previous clinical trials, there was a low dropout rate associated with TRV027, and no significant safety issues were reported. In April 2020, the Company filed a provisional patent application with the United States Patent and Trademark Office covering the use of TRV027 to treat ARDS and the prevention or treatment of abnormal clotting in COVID-19 patients.

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 U.S., 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.

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.

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 Business Officer
Trevena, Inc.
(610) 354-8840