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A heart-felt boost
KING OF PRUSSIA, Pa.—Almost two months to the day after announcing Phase IIa trial results for the intravenous drug TRV027, Trevena Inc., a clinical-stage pharmaceutical company with a focus on the discovery and development of G protein coupled receptor (GPCR) biased ligands, announced a collaborative licensing option agreement for TRV027 with New York-based Forest Laboratories Inc. through its subsidiary Forest Laboratories Holding Ltd.
Trevena expects to commence a 500-patient multicenter Phase IIb clinical trial for the angiotensin II type 1 receptor (AT1R) biased ligand in acute decompensated heart failure (ADHF) by year's end. The results of the Phase IIa study, which ended in October 2012, came out officially on March 8.
Neither party has given out details about the deal, but they did note that it includes a $30 million equity investment by Forest, essentially leading Trevena's $60-million Series C financing round. The terms also call for the grant by Trevena to Forest of an option to exclusively license TRV027 on a worldwide basis following completion of the planned Phase IIb clinical trial, which will be funded by Trevena.
Reportedly, the companies are establishing a joint development committee to oversee the development of TRV027, with Trevena retaining operational authority during the option period. Following the exercise of the option, Forest would make payments of as much as $430 million, depending upon the achievement of future development and commercial milestones, plus royalties, and would have responsibility for the development and commercialization of the product.
According to David Solomon, Forest's senior vice president of corporate development and strategic planning, "TRV027 represents an important opportunity for Forest to build on our presence in the cardiovascular market and the hospital segment. ADHF is the fourth-leading cause of hospitalizations in the United States and there has been no material change in the standard of care for patients with ADHF for decades. TRV027 has the potential to be a significant new advance in the treatment of ADHF because it addresses the underlying pathophysiology of the disease which has been demonstrated in preclinical and early clinical work by Trevena."
Maxine Gowen, Trevena's president and CEO sees the Forest deal, announced May 9, in part as a chance to further validate her company's biased ligand approach to GPCR drug discovery, adding that "Forest Labs brings a wealth of drug development and commercialization experience to the TRV027 program. This collaboration provides us with an opportunity to maximize the potential of this promising compound."
TRV027 is a novel beta-arrestin biased ligand of AT1R that is said to combine the proven benefits of angiotensin blockade with new beta-arrestin-mediated biology to preserve cardiac and renal function.
In the Phase IIa results presented at the American College of Cardiology meeting in March, Trevena showed that TRV027 was generally well tolerated and reportedly produced a beneficial set of hemodynamic effects.
The completed Phase IIa study was a randomized, double-blind, placebo-controlled, adaptive, ascending dose-titration study to evaluate the safety, tolerability, pharmacokinetics and invasive hemodynamics of TRV027 in patients with stable NYHA Class 3 and 4 heart failure. Thirty-three catheterized patients were enrolled at centers in the United States and Europe. Twenty-four patients received TRV027 and nine patients received placebo.
"TRV027 is the lead asset in our biased ligand portfolio, and we are delighted that these results support its progression to a proof-of-concept study in ADHF," Gowen said in March.
The American Heart Association (AHA) estimates that ADHF hospitalization costs the U.S. healthcare system alone more than $20 billion each year in direct spending, not to mention that ADHF is reportedly the leading reason for hospitalization of individuals over 65 years old in the United States at more than 1.3 million hospital admissions per year. Furthermore, the AHA says, ADHF is the most costly diagnosis for Medicare.
Despite the significance of this problem, current therapies are not producing meaningful improvements in patient outcomes, Trevena and Forest Labs note, adding that ADHF incidence is increasing globally, and both heart failure mortality and hospital re-admission following an ADHF event remain extremely high.