An independent Safety Monitoring Committee recommended advancement to Cohort 2 of the Phase 1b registrational study of SER-252 after a blinded review.
Serina Therapeutics claims blinded observations from Cohort 1, which evaluated the lowest single-ascending dose, showed a pharmacokinetic profile consistent with the sustained apomorphine exposure SER-252 is designed to provide and included sustained periods of improvement in motor function in individual patients on exploratory clinical measures.
The committee’s recommendation, based on blinded safety and tolerability data, supports continued dose escalation, according to the company.
Cohort 1 enrolled eight patients with Parkinson’s disease and motor fluctuations in a randomized, double-blind, placebo-controlled design with 3:1 randomization to SER-252 or placebo.
The study’s single-ascending-dose portion comprises five cohorts of eight patients and the multiple-ascending-dose component may include up to three cohorts of 16 patients each.
The trial is being conducted across sites in the U.S., Australia, South Korea and Taiwan. The company expects to report topline data from the single-ascending-dose portion in the first half of 2027.
Serina describes SER-252 as an investigational, long-acting apomorphine formulation enabled by its POZ technology, intended to provide continuous dopaminergic stimulation and reduce administration burden.
