New funding to support Serina’s SER-252 trial in advanced Parkinson’s
Study evaluating apomorphine-based therapy now dosing patients
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- Serina entered agreements for up to $30M to support the SER-252 trial in advanced Parkinson’s disease.
- SER-252 (POZ-apomorphine) is designed to provide more consistent drug delivery via a wearable subcutaneous device.
- The therapy will be evaluated for effects on motor function and daily activities in people with Parkinson’s.
Serina Therapeutics has entered into definitive agreements for a private placement that could provide up to $30 million to support the advancement of its clinical trial evaluating SER-252 (POZ-apomorphine) as a treatment for people with advanced Parkinson’s disease.
The global Phase 1b trial (NCT07422675) is evaluating the safety, tolerability, pharmacokinetics, and exploratory efficacy of single doses of SER-252 in about 40 patients at four sites in the U.S. and Australia. The company announced in February that the study had begun enrollment. Initial dosing is underway at clinical sites in Australia.
Funding supports advancement of SER-252 clinical trial
“With the first patient dosed in our registrational trial and a clear 505(b)(2) pathway aligned with the [U.S. Food and Drug Administration], this financing positions Serina to execute on the most value-creating milestones in the company’s history,” Steve Ledger, Serina’s CEO, said in a company press release.
A registrational trial is one designed to generate data that, if positive, may support an application seeking a therapy’s approval. The 505(b)(2) regulatory pathway allows companies to rely in part on data from already approved drugs — which is the case for SER-252’s active ingredient, apomorphine.
“We remain laser-focused on generating the clinical data that will demonstrate the potential of SER-252 to transform the treatment of advanced Parkinson’s disease,” Ledger said.
The company expects that a review of trial data from the first group of patients by an independent Safety Review Committee will support advancing to a second group of patients in the third quarter, and that top-line results will be available in the first half of 2027.
Parkinson’s disease and current treatment options explained
Parkinson’s is caused by the gradual loss of dopaminergic neurons, nerve cells that produce dopamine, a signaling molecule that helps brain cells communicate. Levodopa, widely considered the gold standard treatment for Parkinson’s, provides a substance that the body can use to make dopamine, helping restore its levels.
While levodopa can effectively ease Parkinson’s symptoms, long-term use may lead to side effects such as off episodes — periods when symptoms return between doses — and dyskinesia, or sudden, involuntary movements.
Apomorphine is a molecule that mimics the effects of dopamine in the brain. Some formulations, such as Apokin (given as an under-the-skin, or subcutaneous, injection) and Onapgo (a continuous subcutaneous infusion), are approved to reduce off episodes in Parkinson’s.
According to the company, SER-252, given as a subcutaneous injection, is designed to better control how apomorphine is released in the body, with the goal of providing more consistent delivery of the medication over time.
The Phase 1b trial’s main goal is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SER-252, given as a single subcutaneous dose using the Enfuse wearable device.
Pharmacokinetics refers to how a therapy moves into, through, and out of the body, while pharmacodynamics describes its effects on the body. Serina has partnered with Enfuse’s developer, Enable Injections, to support delivery of the treatment through this wearable device.
Study will evaluate safety, dosing, and motor function outcomes
The trial will also assess how the treatment affects patients’ motor function and daily activities, using the validated Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) parts 2 and 3, respectively.
Last year, the company announced $5 million in funding to support the clinical development of SER-252. The new financing, now announced, was led by Greg Bailey, MD, Serina’s board director and co-founder and executive chairman of Juvenescence, who will become co-chairman of the board of directors.
“Serina’s POZ technology has the potential to improve the safety and pharmacokinetic profile of drugs that have historically been constrained by side effects, opening the door to a portfolio of optimized medicines,” Bailey said. “SER-252 has the potential to become a best-in-class therapy for the approximately 250,000 advanced Parkinson’s patients in the U.S. and Europe whose symptoms remain inadequately controlled by current treatments.”
