TREVENA, INC. (NASDAQ:TRVN) Files An 8-K Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure
In its May 15, 2020 issue, the journal Circulation published online an article titled: β-Arrestin-Biased Angiotensin II Receptor Agonists for COVID-19, Manglik A, Wingler LM, Rockman, HA, Lefkowitz, RJ. This article hypothesizes that targeting the AT receptor with a selective agonist, such as TRV027, may offer a new approach to disrupting the cellular pathway that contributes to COVID-19-related acute respiratory distress syndrome (ARDS). It also proposes the potential therapeutic advantage of this approach compared to angiotensin receptor blockers (ARBs) and ACE inhibitors currently being investigated in clinical trials, due to the unique downstream signaling effects of an AT receptor selective agonist. Trevena, Inc. (the “Company”) has received interest from multiple institutions regarding potential studies that could evaluate the use of its investigational new drug, TRV027, in COVID-19 patients. TRV027 has previously been studied in 691 patients, completed a Phase 2b trial in acute heart failure, and has a well-established safety profile.
Forward-Looking Statements
Any statements in this Current Report on Form 8-K about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development and trials of its 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: uncertainties related to the global COVID-19 pandemic; the status, timing, costs, results and interpretation of the Company’s clinical trials or any future trials of any of the Company’s product candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company’s assessment of the discussions with FDA and the timing of FDA’s decision on the oliceridine NDA; available funding; and other factors discussed in the Risk Factors set forth in the Company’s Annual Report on Form 10-K filed with the SEC and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this report 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.
About TREVENA, INC. (NASDAQ:TRVN)
Trevena Inc. is a clinical-stage biopharmaceutical company. The Company discovers, develops and intends to commercialize therapeutics that use an approach to target G protein coupled receptors (GPCRs). Using its product platform, the Company has identified and advanced three differentiated product candidates: Oliceridine (TRV130), TRV027 and TRV250. Its TRV130 is a Mu-receptor G protein Pathway Selective (Mu-GPS) modulator that activates G protein. Its TRV250 is a small molecule G protein biased ligand of the d-opioid receptor in preclinical development. Its TRV734 is a small molecule Mu-GPS that it has discovered and has developed through Phase I as a first-line, orally administered compound for the treatment of moderate to severe acute and chronic pain. Its TRV027 is a peptide b-arrestin biased ligand that targets the angiotensin II type 1 receptor (AT1R). In addition to these three product candidates, the Company has identified and has completed the Phase I program for TRV734.
