The first patient has been enrolled in a Parkinson’s drug trial evaluating a new treatment for advanced Parkinson’s disease.
The Phase 1b registrational study is assessing safety, tolerability, pharmacokinetics and early effectiveness in patients whose symptoms are not adequately controlled by standard treatments.
It focuses on people experiencing motor fluctuations, meaning unpredictable shifts between good symptom control and periods when medication wears off.
The trial is being run by Serina Therapeutics and is evaluating SER-252, an investigational therapy based on the company’s proprietary drug delivery platform.
It is designed to provide sustained exposure to apomorphine through a subcutaneous injection, meaning it is given under the skin.
“Enrolling our first patient represents an important operational milestone as we advance SER-252 into the clinic,” said Steve Ledger, CEO of Serina Therapeutics.
“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.”
The company said the approach aims to keep patients within a therapeutic range for longer and may reduce motor complications linked to current therapies.
Serina Therapeutics said the Phase 1b study follows regulatory clearance that allowed clinical activities to begin and is intended to generate data to support future regulatory submissions.
The trial forms part of the company’s broader strategy to develop treatments for neurological disorders using polymer-based drug optimisation technology, with Parkinson’s disease as the lead clinical indication.
AI chatbots may worsen mental illness, study warns
