New Haven-based Biohaven Pharmaceutical Holding Co. Ltd. announced disappointing results this week from a clinical trial of a drug to potentially treat spinocerebellar ataxia, a rare and debilitating brain disorder.
The drug, trigriluzole, performed worse than a placebo after eight weeks of treatment in a Phase 2/3 clinical trial of 141 patients with the disease, according to results released by the company.
On one scale used in the study, 50.8 percent of subjects treated with the drug considered themselves improved, versus 59.1 percent treated with a placebo.
On the upside, the study found the drug to be safe and well-tolerated, the company said. The drug maker said the placebo response was higher than expected for the disorder.
“We are obviously disappointed that today’s topline clinical results do not support continued development of trigriluzole as a symptomatic agent for patients with SCA, a devastating neurologic disorder for which novel treatments are urgently needed,” said Dr. Vlad Coric, Biohaven’s CEO. “This was the largest SCA trial performed to date and important knowledge was generated.”
He said Biohaven would be sharing data with the National Ataxia Foundation to help refine future clinical trials for the inherited disorder, which results in progressive problems with movement. A long-term, open-label, extension phase study on the drug is ongoing with results expected in late 2018.
Meanwhile, the company said it is proceeding with a Phase 2/3 trial of trigriluzole for OCD after receiving FDA approval last week. That study is scheduled to enroll its first patient in the coming weeks. Last month, Biohaven announced a clinical trial to test the drug’s effectiveness in treating Alzheimer’s patients.
Natalie Missakian can be reached at news@newhavenbiz.com
