First patient enrolled in new SER-252 trial for advanced Parkinson’s disease
Study will evaluate safety, tolerability, and pharmacokinetics
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- A Phase 1b trial of SER-252 (POZ-apomorphine) in advanced Parkinson’s disease has enrolled its first patient.
- SER-252 is designed to reduce “off” episodes by providing continuous dopaminergic stimulation.
- The trial is evaluating safety and early efficacy, and the therapy is designed for subcutaneous self-administration.
A Phase 1b clinical trial evaluating Serina Therapeutics’s SER-252 (POZ-apomorphine) in people with advanced Parkinson’s disease has enrolled its first patient, the company announced.
The global registrational trial is evaluating the treatment’s safety, tolerability, pharmacokinetics, and preliminary efficacy. The first group of participants is being enrolled in Australia, where the company has an operational presence. Serina said it expects to begin dosing in the first quarter and plans to provide updates as enrollment progresses.
Phase 1b study designed to support regulatory development
Serina said the trial is intended to generate data to support future regulatory submissions.
“Enrolling our first patient represents an important operational milestone as we advance SER-252 into the clinic,” Steve Ledger, Serina’s CEO, said in a company press release. “Our team has built a strong operational presence in Australia, working closely with leading Parkinson’s disease specialists and patient advocacy organizations to support efficient enrollment.”
Serina has said it plans to pursue SER-252 through the U.S. Food and Drug Administration’s 505(b)(2) regulatory pathway, which allows companies to rely in part on data from previously approved drugs.
Parkinson’s disease is caused by the progressive loss of dopaminergic neurons, the nerve cells that produce dopamine, a chemical messenger the brain uses to coordinate movement. Levodopa is a mainstay treatment that helps ease motor symptoms by providing a precursor molecule the body converts into dopamine.
However, long-term levodopa use can cause side effects such as dyskinesia, or involuntary movements, and many patients experience “off” episodes, periods of reduced symptom control that occur between doses.
How SER-252 is designed to treat off episodes
SER-252’s active ingredient, apomorphine, is a dopamine agonist that mimics the effects of dopamine in the brain, with the goal of reducing off episodes. It is designed to provide continuous dopaminergic stimulation and to be self-administered through subcutaneous (under-the-skin) injections.
Continuous dopaminergic stimulation has been associated with reduced severity of levodopa-related motor complications in Parkinson’s disease. In preclinical studies, SER-252 demonstrated a favorable safety profile and provided continuous drug delivery following weekly subcutaneous injections. The company said these studies support the potential for SER-252 to provide continuous dopaminergic stimulation without skin reactions.
Last year, Serina announced new funding to support the clinical development of SER-252. The company has also partnered with Enable Injections to deliver SER-252 using its Enfuse wearable device, which is intended to allow more convenient self-administration.
