Serina Therapeutics has enrolled the first patient in its Phase Ib registrational trial of SER-252 for advanced Parkinson’s disease (PD).
The study is assessing the safety, pharmacokinetics, tolerability and initial efficacy of SER-252 in individuals with advanced PD whose symptoms are not adequately controlled by existing treatments.
It is set to begin dosing patients this quarter, in line with prior guidance from Serina Therapeutics.
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Serina Therapeutics has established collaborations with Parkinson’s Australia and Neuroscience Trials Australia to aid patient identification and recruitment activities for the Phase Ib trial. The company intends to release further updates as patient enrolment progresses.
Serina Therapeutics CEO Steve Ledger said: “Enrolling our first patient represents an important operational milestone as we advance SER-252 into the clinic. Our team has built a strong operational presence in Australia, working closely with leading Parkinson’s disease specialists and patient advocacy organisations to support efficient enrolment.
“With FDA alignment on our registrational development strategy under a 505(b)(2) NDA pathway, we are focused on executing this trial and generating meaningful clinical data for patients with advanced Parkinson’s disease who face significant unmet medical needs.”
SER-252 is an investigational therapy based on apomorphine, developed using Serina Therapeutics’ POZ platform to provide continuous dopaminergic stimulation (CDS).
Serina Therapeutics’ POZ technology uses poly(2-oxazoline), a synthetic, water-soluble polymer designed for precise drug loading and controlled subcutaneous release.
By employing this technology, Serina aims to maintain stable drug levels for therapies with narrow therapeutic windows.
The company is also exploring broader applications of its POZ platform, including out-licensing agreements such as its non-exclusive licence with Pfizer for lipid nanoparticle drug delivery formulations.
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