US-based Auspex Pharmaceuticals has completed enrolment of the planned 90 patients in its Phase III registration clinical trial (First-HD) of SD-809 to treat chorea associated with Huntington’s disease (HD).
The company, which is focused on developing and commercialising novel medicines for the treatment of orphan diseases, expects to report the topline data from the trial in the fourth quarter of this year.
Auspex chief medical officer Dr David Stamler said: “The completion of enrolment of the First-HD trial represents an important milestone for both the company and the SD-809 programme.
“We are gratified by the interest and support shown by the HD patients, the care givers, the HD advocacy groups and the treating physicians in this trial.
“We believe that SD-809 has the potential to be an important new treatment for these patients.”
The randomised, double-blind, placebo-controlled, parallel-group First-HD trial of SD-809 is designed to evaluate and generate label information for the safety, tolerability and efficacy of SD-809 for this treatment.
If the primary endpoint of the trial is met, the company plans to submit a Section 505(b)(2) new drug application, for SD-809 to the US Food and Drug Administration (FDA).
Additionally, the company has started an open-label clinical trial, which is referred to as ARC-HD, that will assess long-term safety and also offer guidance on how to switch patients who are currently on tetrabenazine to SD-809.
The trials are being carried out with the Huntington Study Group.
The company’s pipeline include product candidates to address unmet medical needs in hyperkinetic movement disorders, such as chorea associated with HD, tardive dyskinesia and Tourette syndrome, and fibrotic indications, including idiopathic pulmonary fibrosis (IPF) and other orphan conditions.
