Bristol-Myers Squibb has discontinued development of a hepatitis C drug obtained through its recent $2.50 billion acquisition of Inhibitex following the death of a participant in a mid-stage trial.
The drug in question is BMS-986094 (formerly known as INX-189), a nucleotide polymerase (NS5B) inhibitor in Phase II development for HCV. The firm said the decision "was made in the interest of patient safety, based on a rapid, thorough and ongoing assessment of patients" in the study that B-MS voluntarily suspended on August 1.
The US Food and Drug Administration subsequently placed the compound on clinical hold and B-MS noted that the initial case of heart failure, which was the basis for halting the study, subsequently resulted in death. To date, nine patients have been hospitalised.
Two patients remain hospitalised and the company noted that while "the cause of these unexpected events, which involve heart and kidney toxicity, has not been definitively established…it is in the best interest of patients to halt development of BMS-986094".
Chief scientific officer Elliott Sigal said that in the interest of all patients participating in hep C clinical studies, "and in cooperation with the FDA, we will make relevant information on BMS-986094 available to inform the development of other investigational compounds".
Shingles drug sold to Synergy
Meantime, B-MS has divested a potential shingles treatment, also developed by Inhibitex, to Synergy Pharmaceuticals of the USA.
The latter firm, which specialises in gastrointestinal disorders, has acquired the assets related to FV-100, an orally-available nucleoside analogue, currently being developed for shingles, the painful skin rash caused by reactivation of the varicella zoster virus that causes chickenpox. No financial details were disclosed.
FV-100 has completed a Phase IIa trial in which the drug was given to 230 patients. Clinically meaningful reductions in time to resolution of clinically significant pain and in incidence of post-herpetic neuralgia were noted.
Synergy chief executive Gary Jacob said "we believe that with our expanding clinical experience in utilising patient-reported outcome tools from our GI programme, a feature that will be necessary for supporting pain-related indications for FV-100, we are in a unique position to further develop [the drug] for patients not adequately treated with present-day therapy".