FDA slaps partial hold on Blueprint Phase I/II VELA trial of BLU-222

The US Food and Drug Administration (FDA) has verbally informed US biotech Blueprint Medicines (Nasdaq: BPMC) that it has placed a partial clinical hold on the Phase I/II VELA trial of BLU-222 due to visual adverse events (AEs) observed in a limited number of patients, the company announced on Friday, with the news pushing the firm’s shares down 7.9% to $40.80 pre-market.

Patients currently enrolled in the trial are continuing on study drug at this time, and additional patients will not be enrolled until the partial clinical hold is resolved.

BLU-222 is currently being evaluated in the Phase I dose escalation portion of the VELA trial. Patients have been treated with BLU-222 at doses ranging from 50mg BID to 800mg BID to date, with evidence of clinical benefit observed and no discontinuations due to AEs.