April 15, 2016
By Alex Keown, BioSpace.com Breaking News Staff
PALO ALTO, Calif. – Following mixed clinical trial results for its osteoarthritis of the knee injectable Hydros-TA, Carbylan Therapeutics said it is suspending clinical development of the therapy and will attempt to make the company attractive for a possible merger or acquisition, the company said Thursday.
Not only is the company ceasing research on its pain medicine and looking to be snapped up by another company, Carbylan said it is also eliminating all but three members of its 17-member workforce to preserve capital and streamline operations in preparation for a “potential strategic transaction.”
Founded in 2004, Carbylan stock closed April 14 at 64 cents per share, up from its opening of 61 cents per share. The stock has seen a steady decline since June 2015, when the stock was trading at $9.04 per share.
Last month Carbylan, which is focused on development of pain treatments, engaged Wedbush PacGrow to act as its strategic financial advisor for this process. The company said it anticipates having between $25 to $30 million of cash available for a potential merger or acquisition by another company. Carbylan hasn’t yet released its 2015 year-end financials. In November 2015, the company released its third-quarter financials, which showed it had $59.8 million in cash and cash equivalents, enough to continue operations for the next 12 months.
In February, Bay Area-based Carbylan announced results from its Phase III trial of Hydros-TA. The primary endpoints were changes from baseline in the WOMAC A pain scores at week 2 for Hydros-TA versus Hydros and at week 26 for Hydros-TA versus triamcinolone acetonide. Safety was also assessed. BioSpace previously reported the study met its primary endpoint by maintaining significant pain reduction over 26 weeks, but its secondary endpoint was not met. In the TA arm, patients continued to show significant reduction in pain through 26 weeks, which was unexpected.
Hydros-TA is a proprietary, cross-linked combination of low dose corticosteroid and novel hyaluronic acid viscosupplement, designed to provide both rapid and sustained osteoarthritis pain relief via a single intra-articular injection.
Carbylan isn’t the only company developing osteoarthritis treatments that has run into trouble with its treatment. Earlier this month, Janssen Research & Development, a subsidiary of Johnson and Johnson , terminated its Phase III development program for fulranumab in osteoarthritis pain due to a “strategic portfolio prioritization.” Fulranumab is part of an experimental class of non-opioid biological medicines called anti-nerve growth factor compounds. Those drug compounds had been placed on a hold by the U.S. Food and Drug Administration (FDA) in 2011 due to heightened risk of joint damage, Seeking Alpha noted. The FDA’s hold has been lifted. Janssen said their reasons for terminating the agreement had nothing to do with safety concerns.
