Blueprint Still Confident In CDK2 Inhibitor Despite Partial Hold On Phase I/II Trial

The FDA placed a partial hold on the VELA study of BLU-222 due to some patients experiencing visual toxicity, but the company anticipates reporting data and said it is near identifying Phase II dose.

Blueprint said the FDA placed a partial hold on its Phase I/II CDK2 inhibitor trial • Source: Shutterstock

Blueprint Medicines Corporation’s move into the competitive CDK2 inhibitor space has hit an obstacle as the US Food and Drug Administration has slapped a partial clinical hold on its Phase I/II VELA trial of BLU-222 due to some patients experiencing visual adverse events. But the company anticipates resolving the hold and remains on track to present dose-escalation data in the first half of 2023.

Blueprint announced the hold on 10 February, two days after it was notified by the FDA, and said the events...