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Enable Injections and Serina Therapeutics Announce Agreement to Develop SER-252 in Combination with enFuse® for Advanced Parkinson’s Disease

CINCINNATI and HUNTSVILLE, Alabama, May 15, 2024 (GLOBE NEWSWIRE) — Enable Injections, Inc. (“Enable”), a healthcare innovation company developing and manufacturing the enFuse® wearable drug delivery platform and Serina Therapeutics (“Serina”) (NYSE American: SER), a clinical-stage biotechnology company advancing its POZ Platform™ to develop and improve efficacy and safety across multiple modalities including small molecules, RNA-based therapeutics and antibody-based drug conjugates (ADCs), today announced a partnership to develop and commercialize SER-252 (POZ-apomorphine) in combination with enFuse for the treatment of Parkinson’s disease.

SER-252 is an investigational apomorphine therapy developed with Serina’s POZ platform and designed to provide continuous dopaminergic stimulation (CDS). CDS has been shown to reduce the severity of levodopa-related motor complications (dyskinesia) in Parkinson’s disease. Preclinical studies support the potential of SER-252 to provide CDS without skin reactions. Serina plans to advance SER-252 to clinical testing in 2025.

enFuse is an innovative, wearable drug delivery platform 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. enFuse is designed to overcome both IV infusion and other subcutaneous administration method shortcomings through fast, simple, and convenient delivery, benefiting patients, providers, as well as payers, with the ability for patient self-administration.

“Current apomorphine treatments require daily and time-consuming infusions through an electronic pump that not only burdens patients and providers, but can cause significant skin reactions,” said Randall Moreadith, M.D., Ph.D., Chief Development Officer of Serina Therapeutics. “With enFuse, patients can self-administer SER-252 in the convenience of their home with wearable technology and with a rapid treatment time. If effective, a SER-252 and enFuse combination provides the potential for patients to remain in a continuous ‘ON’ state and avoid dyskinesia.”

“The partnership with Serina Therapeutics continues to validate the applicability of enFuse across various therapeutic areas, even in the field of Parkinson’s, where multiple routes of treatment administration already exist, including subcutaneous methods. The technology and benefits of enFuse have the potential to significantly reduce many of the burdens associated with the current standard of care for Parkinson’s,” said Mike Hooven, Chairman and CEO of Enable Injections. “We greatly look forward to bringing those living with, and treating, Parkinson’s disease an improved treatment experience that is more convenient, less time-consuming, and less disruptive to their lives with SER-252 in combination with enFuse.”

Enable is currently working with a number of pharmaceutical partners to conduct clinical trials and plan for joint commercial launch of their therapies in combination with the enFuse technology. Enable continues to selectively add to its list of pharmaceutical partners, with indications and patient populations who will benefit from the enFuse system. The first enFuse combination product received U.S. Food and Drug Administration approval in 2023.

“In addition to advancing our pipeline of drug candidates, Serina is focused on partnering with pharmaceutical companies on its POZ Platform™ to improve the integrated safety and efficacy profile of small molecules, RNA-based therapeutics and ADCs. Serina’s collaboration with Enable is the first of many potential partnerships,” said Dr. Simba Gill, Executive Chairman of Serina Therapeutics.

Under the terms of the agreement, Serina will obtain a worldwide, exclusive license to the enFuse platform for an upfront and future milestone payments. Enable will also be entitled to product sales and single digit royalties.

View the original press release on Globe Newswire.