Parkinson’s therapy delivered via wearable shows trial promise

A wearable-delivered Parkinson’s therapy eased motor symptoms in some patients with advanced disease, preliminary trial observations suggest.

An independent safety monitoring committee has recommended that the Phase 1b trial of SER-252 move to a second dosing group.

The panel reviewed safety and tolerability data from the first eight patients, who received the lowest dose. This dose provided the sustained exposure to apomorphine the treatment is designed to deliver.

SER-252 is Serina Therapeutics’ long-acting form of apomorphine, a dopamine agonist that activates the same brain receptors as dopamine.

Steve Ledger, chief executive of Serina, said: “These initial observations strengthen our confidence in SER-252 and are consistent with the profile the programme was designed to achieve.”

The Phase 1b trial continues to enrol patients at sites in the US and Australia, with top-line data expected in the first half of 2027.

Parkinson’s develops as dopamine-producing nerve cells gradually die. Dopamine plays an important role in controlling movement, and its loss contributes to motor symptoms including tremor, stiffness and slowed movement.

Levodopa, one of the main treatments for Parkinson’s, helps replenish the brain’s dopamine supply and can ease motor symptoms.

With long-term use, however, patients can develop dyskinesia, or involuntary movements, and experience off episodes, when medication wears off and motor symptoms return before the next dose.

Apomorphine is approved in the US to treat motor fluctuations in Parkinson’s and is available as the under-the-skin injection Apokyn and the continuous infusion treatment Onapgo.

Ledger said “available approaches for sustained delivery can impose a significant treatment burden”.

SER-252 uses Serina’s POZ technology to control how quickly apomorphine is released after an injection under the skin, with the aim of providing sustained exposure to the drug.

“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 favourable safety profile and provided continuous drug delivery following weekly injections under the skin.

The Phase 1b trial began enrolling patients in February. Participants are randomly assigned to receive a single dose of SER-252 or a placebo.

Successive groups receive higher doses, ranging from 0.48 mg/kg to 1 mg/kg of apomorphine equivalent dose.

Patients were withdrawn from their background Parkinson’s medicines under the study protocol to limit the contribution of other treatments acting on the dopamine system.

SER-252 is administered through the Enfuse wearable device under a partnership with its developer, Enable Injections.

The study’s main aim is to assess safety, tolerability and how the treatment moves through and affects the body.

Researchers are also exploring its effects on motor function and daily activities using parts two and three of the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale.

The trial is expected to be registrational, meaning positive findings may be used to support an application for regulatory approval.

The study is being conducted under the US Food and Drug Administration’s 505(b)(2) pathway, which allows developers to rely partly on existing evidence relating to an approved drug’s active ingredient.

In March, Serina announced up to US$30m in funding to support clinical development of SER-252, following an earlier US$5m financing.