Forest Laboratories will join Trevena in developing its clinical-stage acute heart failure drug candidate TRV027, an AT1R biased-ligand that recently completed Phase IIa clinical trials. Under the deal, Forest Labs will make a $30 million investment in Trevena, and could pay Trevena an additional up to $430 million from an exclusive worldwide marketing option, the companies said today.
Trevena, which specializes in developing G-protein coupled receptor- (GPCR-) biased ligands, will join Forest Labs in establishing a joint development committee to oversee development of TRV027, with Trevena retaining operational authority during the marketing option period. Trevena is funding an upcoming 500-patient, multi-center Phase IIb trial, set to start by year’s end, of TRV027 in acute decompensated heart failure (ADHF).
Should Forest Labs exercise its option, it will pay Trevena up to $430 million tied to achievement of undisclosed future development and commercial milestones, plus royalties. Forest Labs will have responsibility for the development and commercialization of the product.
“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,” said David Solomon, Forest’s svp of corporate development and strategic planning, said in a statement. “TRV027 represents an important opportunity for Forest to build on our presence in the cardiovascular market and the hospital segment.”
Solomon noted that while ADHF is the fourth leading cause of hospitalizations in the U.S., there has been no material change for decades in the standard of care for patients with the disorder.
“This collaboration provides us with an opportunity to maximize the potential of this promising compound, and further validates our biased ligand approach to GPCR drug discovery,” Maxine Gowen, Trevena’s president and CEO, said in the statement.
Also under the deal, Forest Labs agreed to invest $30 million in Trevena, taking the lead on a series C financing round expected to raise $60 million from investors. Those investors will include five existing investors in Trevena: Alta Partners, Healthcare Ventures, NEA, Polaris, and Yasuda Enterprise Development Co. All five contributed to a combined $35 million series B round in 2010.
In October, Trevena revealed a summary of topline results from the Phase IIa trial, which the company said demonstrated the safety and anticipated pharmacology of TRV027 in patients with advanced heart failure with reduced ejection fraction. TRV027 rapidly and reversibly decreased both blood pressure and pulmonary capillary wedge pressure, preserved kidney function as measured by creatinine and cystatin C, and preserved cardiac output, Trevena said. No drug-related serious adverse events were reported.