Wearable-delivered Parkinson’s therapy shows promise in early trial
Monitoring panel recommends SER-252 trial advance to second dosing group
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- SER-252, a long-acting apomorphine therapy delivered via a wearable device, eased motor symptoms in some trial patients with advanced Parkinson's.
- A safety panel recommended the Phase 1b trial advance to a second dosing group.
- The trial is enrolling patients at sites in the U.S. and Australia.
A Parkinson’s disease therapy delivered through a wearable device eased motor function in some patients with advanced Parkinson’s, according to preliminary observations from an ongoing Phase 1b trial.
An independent safety monitoring committee recommended that the trial of SER-252, Serina Therapeutics’ long-acting form of apomorphine, advance to a second dosing group. The panel reviewed safety and tolerability data from the first eight patients, who received the lowest dose of the drug. This dose provided the sustained exposure to apomorphine that the treatment aims to deliver.
“These initial observations strengthen our confidence in SER-252 and are consistent with the profile the program was designed to achieve,” Steve Ledger, Serina’s CEO, said in a company press release.
The Phase 1b trial (NCT07422675) is still enrolling patients at sites in the U.S. and Australia. The company expects to report top-line data in the first half of 2027.
Parkinson’s disease develops as dopaminergic neurons, the nerve cells that produce dopamine, gradually die. Dopamine is important for controlling movement, and its loss contributes to motor symptoms such as tremor, stiffness, and slowed movement.
Sustained delivery approach
Levodopa, one of the main treatments for Parkinson’s, helps replenish the brain’s dopamine supply and eases motor symptoms. However, with long-term use, patients can develop dyskinesia (involuntary movements) and experience off episodes, when the medication’s effects wear off and motor symptoms return before the next dose.
Apomorphine is a dopamine agonist that activates the same brain receptors as dopamine. It is approved in the U.S. to treat motor fluctuations in Parkinson’s and is commercially available as Apokyn, an under-the-skin (subcutaneous) injection, and Onapgo, a continuous infusion treatment. However, “available approaches for sustained delivery can impose a significant treatment burden,” Ledger said.
SER-252 was developed using Serina’s proprietary POZ technology to provide more sustained exposure to apomorphine by controlling how quickly the drug is released after being injected under the skin. The goal is to provide continuous dopaminergic stimulation while reducing treatment burden. SER-252’s long-acting profile is designed to overcome the high burden of current approaches, such as frequent rescue injections or bulky continuous infusion pumps.
“SER-252 is designed to provide sustained apomorphine exposure through a convenient, long-acting subcutaneous treatment, with the potential to offer a differentiated next-generation option for these patients,” Ledger said.
In preclinical studies, SER-252 demonstrated a favorable safety profile and provided continuous drug delivery following weekly subcutaneous injections.
The Phase 1b trial began enrolling patients in February. Participants are randomly assigned to receive a single SER-252 dose or a placebo. Each successive cohort evaluates a higher dose of the treatment, ranging from 0.48 mg/kg to 1 mg/kg of apomorphine equivalent dose. In accordance with the study protocol, patients were withdrawn from background Parkinson’s medications to limit the contribution from other dopaminergic therapies.
SER-252 is delivered via the Enfuse wearable device through a partnership with Enable Injections, the device’s developer.
The study’s main goal is to assess the treatment’s safety, tolerability, and its movement and effects in the body. Exploratory goals include assessing the treatment’s effects on patients’ motor function and daily activities, using the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) parts 2 and 3.
The trial is expected to be registrational, meaning it may support an application requesting the therapy’s approval if the data are positive. It is being conducted under the U.S. Food and Drug Administration’s 505(b)(2) regulatory pathway, which allows developers to use existing evidence for an approved drug’s active ingredient, which is the case for apomorphine.
In March, the company announced up to $30 million in funding to support the clinical development of SER-252, following a previous $5 million financing.
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