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: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.
About Enable Injections
Cincinnati-based Enable Injections is a global healthcare innovation company committed to improving the patient treatment experience through the development and manufacturing of enFuse®. enFuse is an innovative wearable drug delivery platform that is designed to deliver large volumes of pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics. For more information about the Company's approved enFuse combination production, visit https://enableinjections.com/our-products.
About Serina Therapeutics
Serina is a clinical-stage biotechnology company developing a pipeline of wholly owned drug product candidates to treat neurological diseases, pain, and other indications. Serina's POZ PlatformTM provides the potential to improve the integrated efficacy and safety profile of multiple modalities including small molecules, RNA-based therapeutics and antibody-based drug conjugates (ADCs). Serina is headquartered in Huntsville, Alabama on the campus of the HudsonAlpha Institute of Biotechnology.
For more information, please visit https://serinatherapeutics.com.
Cautionary Statement Regarding Forward-Looking Statement
This release contains forward-looking statements within the meaning of federal securities laws. These statements are based on management's current expectations, plans, beliefs or forecasts for the future, and are subject to uncertainty and changes in circumstances. Any express or implied statements in this press release that are not statements of historical fact, including statements about the potential of Serina's POZ polymer technology, are forward-looking statements that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any applications may be filed for any drug or vaccine candidates in any jurisdictions; whether and when regulatory authorities may approve any potential applications that may be filed for any drug or vaccine candidates in any jurisdictions, which will depend on a myriad of factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether any such drug or vaccine candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of any drug or vaccine candidates; whether the agreement between Serina and Enable will be successful; uncertainties regarding the impact of COVID-19 on Serina's business, operations and financial results; and competitive developments. These risks as well as other risks are more fully discussed in the company's Annual Report on Form 10-K for the year ended December 31, 2023, the company's Current Report on Form 8-K that was filed with the SEC on April 1, 2024, and the company's other periodic reports and documents filed from time to time with the SEC.
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