Praxis Pushes Ulixacaltamide Into Phase III For Essential Tremor, But Uncertainty Remains

Praxis hopes to initiate a Phase III later in 2023, but an analyst said it is unclear if regulators will align with the company on a proposed primary endpoint.

Praxis announced results from its Phase II study in essential tremor • Source: Shutterstock

Praxis Precision Medicines, Inc. plans to move ulixacaltamide for essential tremor into Phase III development after announcing mixed results from the Phase IIb Essential1 trial, meaning it has found some success in shifting its R&D focus after a study of its drug for depression failed in 2022. But some uncertainty remains about the proposed primary endpoint for the ulixacaltamide Phase III trial based on its communication with US regulators.

The company said 3 March that the results of Essential1 showed a numerical improvement in the primary endpoint of modified...