Perspectives on Enable and Serina's New Partnership to Develop SER-252 for Parkinson Disease

Commentary
Article

Mike Hooven, chairman and CEO of Enable Injections, and Randall Moreadith, MD, PhD, chief development officer of Serina Therapeutics, provided insight on the development plans of SER-252, an investigational apomorphine therapy for advanced Parkinson disease.

Mike Hooven

Mike Hooven

Parkinson disease (PD), one of the most common neurodegenerative disorders worldwide, is typically treated with dopaminergic medications to reduce the severity of symptoms. Discovered in the 1960s, levodopa was the first symptomatic treatment for PD, followed by the availability of dopamine agonists and monoamine oxidase B inhibitors. Over the years, the therapeutic pipeline for PD has grown with a number of investigational agents, with the hope that some may produce substantial disease-modifying impacts on the disease.

Randall Moreadith, MD, PhD, chief development officer of Serina Therapeutics

Randall Moreadith, MD, PhD

Earlier this month, Enable Injections and Serina Therapeutics announced a partnership to develop and commercialize SER-252, an investigational apomorphine therapy. This therapy, developed with Serina’s POZ platform and designed to provide continuous dopaminergic stimulation will be tested in combination with Enable’s enFuse wearable drug delivery platform as a potential treatment for PD. enFuse is designed to deliver large volumes of medications subcutaneously, in which patients receive their needed treatment in a simple injection under the skin, instead of intravenously.

Clinical studies for the agent are expected to begin in 2025. Following the announcement, Mike Hooven, chairman and CEO of Enable Injections, and Randall Moreadith, MD, PhD, chief development officer of Serina Therapeutics, provided commentary on the significance of the partnership and the development of SER-252. The duo provided answers on the mechanism of action of the agent, how it will be used with the enFuse platform, and how it may address issues of PD treatment seen before.

NeurologyLive: What are some of the benefits to this new agreement between Enable and Serina?

Mike Hooven: Serina’s proprietary POZ platform address the limitations of medications that have narrow therapeutic ranges – such as many of the therapies used to treat neurological disorders like Parkinson’s – while Enable’s wearable drug delivery platform overcomes the shortcomings of standard IV injections and infusions – which can be painful, complex, and time-consuming.

Serina and Enable are both committed to improving patient outcomes, and together, we greatly look forward to bringing those living with, and treating, Parkinson’s disease an improved treatment experience that is more convenient and less disruptive.

Describe a bit about the ins and outs of SER-252; how does it operate? How is it different from other approved therapies and agents in the pipeline?

Randall Moreadith, MD, PhD: Patients with advancing Parkinson disease frequently develop “OFF” time –when Parkinson's motor and/or non-motor symptoms return between medication doses. Apomorphine, a rescue therapy, is used to treat “OFF” times, yet can require daily and time-consuming infusions through an electronic pump that can be burdensome to patients and may cause significant skin reactions.

SER-252 is an investigational apomorphine therapy developed with Serina’s POZ platform, which provides greater control in drug loading and more precise release rates of drugs that result in more desirable and stable levels in the blood. SER-252 is engineered to provide continuous dopaminergic stimulation (CDS) over several days following a single injection and is intended to be a preventative therapy, designed to potentially increase “ON” time and prevent the dyskinesia that is often induced by levodopa – the current standard of care for Parkinson.

With testing expected to begin in 2025, what would that look like? Any ideas on the trial and what type of patients would be enrolled? 

Randall Moreadith, MD, PhD: Following approval of our investigational new drug (IND) application by the FDA, Serina plans to initiate a Phase 1 clinical trial in 2025. We look forward to sharing more details on the trial design following review of our application by the Agency.

Are there aspects to PD care that this therapy can directly impact?

Randall Moreadith, MD, PhD: When SER-252 is combined with enFuse wearable technology, patients can self-administer, or have administered by a caregiver, treatment with a simple injection under the skin in the convenience of their home and with a rapid treatment time. Our preclinical studies demonstrate this occurs without skin reactions. We believe this to be a major improvement in care compared to current apomorphine treatments which require daily and time-consuming infusions through an electronic pump that not only burdens patients and providers, but can cause significant skin reactions.

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