Serina Therapeutics announced that it has enrolled its first patient in the Phase 1b registrational study of SER‑252, a poly(2‑oxazoline) (POZ)‑apomorphine therapy for advanced Parkinson’s disease. The enrollment marks the transition from pre‑clinical and Phase 1a work into the first patient‑dosing phase of a registrational trial.
The Phase 1b study will evaluate safety, tolerability, pharmacokinetics and preliminary efficacy in patients whose symptoms are inadequately controlled by current standard‑of‑care therapies. The company plans to begin dosing in the first quarter of 2026, following FDA clearance of the IND in January 2026 after resolving a clinical hold related to an excipient.
"Enrolling our first patient represents an important operational milestone as we advance SER‑252 into the clinic," said Steve Ledger, Chief Executive Officer of Serina Therapeutics. He added that the FDA clearance of the IND is a major milestone and underscores the promise of the SER‑252 program.
The POZ platform enables precise control over drug loading and release rates, allowing SER‑252 to provide continuous dopaminergic stimulation that may reduce levodopa‑related motor complications such as dyskinesia. The platform’s versatility could extend to other drug modalities in the future.
Serina has faced NYSE American listing concerns due to low shareholders’ equity and past losses, but it has secured financing through convertible notes and has an 18‑month cure period to regain compliance. The company’s financial position remains a risk factor as it progresses through clinical development.
Market reaction to the IND clearance earlier in January saw the company’s shares surge over 30% in after‑hours trading, reflecting investor confidence in the company’s ability to overcome regulatory hurdles and advance its lead candidate.
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