{"id":878786,"date":"2025-08-25T18:20:33","date_gmt":"2025-08-25T22:20:33","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/serina-therapeutics-announces-fda-feedback-supports-registrational-trial-design-of-ser-252-in-advanced-parkinsons-disease-under-505b2-nda-pathway\/"},"modified":"2025-08-25T18:20:33","modified_gmt":"2025-08-25T22:20:33","slug":"serina-therapeutics-announces-fda-feedback-supports-registrational-trial-design-of-ser-252-in-advanced-parkinsons-disease-under-505b2-nda-pathway","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/serina-therapeutics-announces-fda-feedback-supports-registrational-trial-design-of-ser-252-in-advanced-parkinsons-disease-under-505b2-nda-pathway\/","title":{"rendered":"Serina Therapeutics Announces FDA Feedback\u00a0Supports Registrational Trial Design of SER-252 in Advanced Parkinson\u2019s Disease under 505(b)(2) NDA Pathway"},"content":{"rendered":"
\n

–\u00a0U.S. <\/em>IND<\/em> filing planned for Q4 2025 with U.S. enrollment expected to start in Q1 2026 <\/em><\/p>\n

\n – Patient dosing expected to begin in Australia in Q4 2025 <\/em>\n <\/p>\n

\n HUNTSVILLE, AL, Aug. 25, 2025 (GLOBE NEWSWIRE) — <\/strong>Serina Therapeutics, Inc. (\u201cSerina\u201d) (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform\u2122<\/sup>\u00a0drug optimization technology,\u00a0today announced that following a recent Type B meeting with the U.S. Food and Drug Administration (FDA), the FDA\u2019s written feedback supports advancing SER-252 (POZ-apomorphine) in a registrational clinical study program in advanced Parkinson\u2019s under the 505(b)(2) NDA pathway.<\/p>\n

\u201cPeople living with advanced Parkinson\u2019s need more consistent relief from motor fluctuations and our data to date suggest that SER-252 may reliably improve daily function,\u201d said Steve Ledger, Chief Executive Officer of Serina Therapeutics. \u201cBased on the FDA\u2019s written feedback, we plan to advance SER-252 on a registration-directed 505(b)(2) NDA regulatory pathway. Our development plan is designed to be rigorous and capital efficient. We aim to streamline a potential NDA while generating the clinical and pharmacologic evidence to support regulatory review and improve patients\u2019 lives.\u201d<\/p>\n

In its discussions with the FDA, Serina outlined a program designed to leverage prior knowledge of apomorphine utilizing the company\u2019s POZ-enabled profile. Serina plans to include a pharmacokinetic (PK) bridging component to an approved apomorphine product, consistent with a 505(b)(2) NDA strategy. The FDA\u2019s feedback indicates that Serina\u2019s initial study may be designed and conducted as a component of a registrational trial program, subject to standard clinical and nonclinical requirements and finalization of documentation at the time of IND submission.<\/p>\n

\u201cBeyond SER-252, we are advancing a pipeline of POZ-enabled small molecules that may follow similar 505(b)(2) NDA pathways where appropriate,\u201d said Mr. Ledger. \u201cThe FDA\u2019s feedback provides early proof-of-principle for our platform, confirming that we can effectively align with the agency’s expectations for the 505(b)(2) NDA regulatory pathway. Each program will follow its own science and require FDA dialogue, but our goal remains to unlock new possibilities in treatment and deliver better options to patients as quickly as possible.\u201d<\/p>\n

\n Upcoming Regulatory and Clinical Milestones <\/strong>\n <\/p>\n

Serina plans to submit the U.S. IND application in Q4 2025 incorporating the FDA\u2019s recommendations. In parallel, the company expects to begin dosing patients in Australia in Q4 2025 as part of the global registrational program, with data from these patients expected to contribute to the overall data package for regulatory review and potential approval. Following U.S. IND clearance, Serina anticipates initiation of enrollment in the U.S. in Q1 2026.<\/p>\n

\n SER-252 Registrational Study Design Overview<\/strong>\n <\/p>\n

The SER-252-1b study is a randomized, double-blind, placebo-controlled Phase 1b trial with single-ascending-dose (five cohorts of eight; n=40) and multiple-ascending-dose components (up to three cohorts of sixteen; n=48) in adults with Parkinson\u2019s disease and motor fluctuations. The study is designed to evaluate safety, tolerability, and pharmacokinetics of subcutaneous SER-252 versus placebo, with exploratory efficacy measures that include MDS-UPDRS motor scores and structured motor-state assessments. Dose escalation will be overseen by a Safety Review Committee and the study will be conducted across sites in the U.S. and Australia.<\/p>\n

\n About SER-252 (POZ-apomorphine)<\/strong>\n <\/p>\n

SER 252 is an investigational apomorphine therapy developed with Serina\u2019s POZ platform and designed to provide continuous dopaminergic stimulation (CDS) via a single or twice-weekly subcutaneous injection. CDS has been shown to reduce the severity of motor fluctuations (which includes levodopa-induced dyskinesia) and enable greater daily on time, with reduced off time, in advanced Parkinson\u2019s patients. SER-252 leverages strategic partner Enable Injections\u2019 enFuse\u2122<\/sup>\u00a0wearable drug delivery platform to enhance patient comfort and convenience, providing CDS to patients via an easy-to-administer, long-acting subcutaneous injection.<\/p>\n

\n About the POZ Platform<\/strong>
\n
\n \u2122<\/strong>
\n <\/sup>\n <\/p>\n

Serina\u2019s proprietary POZ technology is based on a synthetic, water soluble, low viscosity polymer called poly(2-oxazoline). Serina\u2019s POZ technology is engineered to provide greater control in drug loading and more precision in the rate of release of attached drugs delivered via subcutaneous injection. The therapeutic agents in Serina\u2019s product candidates are typically well-understood and marketed drugs that are effective but are limited by pharmacokinetic profiles that can include severe skin reactions, side effects due to peak-trough variations in drug levels and a short half-life. Serina believes that by using POZ technology, drugs with a narrow therapeutic index can be designed to maintain more desirable and stable levels in the blood. Serina\u2019s POZ platform delivery technology has potential for use across a broad range of payloads and indications.<\/p>\n

\n About Serina Therapeutics<\/strong>\n <\/p>\n

Serina is a clinical-stage biotechnology company developing a pipeline of wholly owned drug product candidates to treat neurological diseases and other indications. Serina\u2019s POZ Platform\u2122<\/sup>\u00a0provides 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\u00a0https:\/\/serinatx.com<\/a><\/u>.<\/p>\n

\n Cautionary Statement Regarding Forward-Looking Statement<\/strong>\n <\/p>\n

This release contains forward-looking statements within the meaning of federal securities laws. These statements are based on management\u2019s 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\u2019s 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\u2019s benefits outweigh its known risks and determination of the product\u2019s 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; and competitive developments. These risks as well as other risks are more fully discussed in Serina\u2019s Annual Report on Form 10-K, and Serina\u2019s other periodic reports and documents filed from time to time with the SEC. The information contained in this release is as of the date hereof, and Serina assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. The information contained in this release is as of the date hereof, and Serina assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.<\/p>\n

\n For inquiries, please contact:<\/strong>
\n
Stefan Riley
sriley@serinatherapeutics.com<\/a><\/u><\/strong>
(256) 327-9630<\/p>\n

\"\"
\n
\n \"\"\n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

–\u00a0U.S. IND filing planned for Q4 2025 with U.S. enrollment expected to start in Q1 2026 – Patient dosing expected to begin in Australia in Q4 2025 HUNTSVILLE, AL, Aug. 25, 2025 (GLOBE NEWSWIRE) — Serina Therapeutics, Inc. (\u201cSerina\u201d) (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform\u2122\u00a0drug optimization technology,\u00a0today announced that following a recent Type B meeting with the U.S. Food and Drug Administration (FDA), the FDA\u2019s written feedback supports advancing SER-252 (POZ-apomorphine) in a registrational clinical study program in advanced Parkinson\u2019s under the 505(b)(2) NDA pathway. \u201cPeople living with advanced Parkinson\u2019s need more consistent relief from motor fluctuations and our data to date suggest that SER-252 may reliably improve daily function,\u201d said Steve Ledger, Chief … <\/p>\n

Continue reading “Serina Therapeutics Announces FDA Feedback\u00a0Supports Registrational Trial Design of SER-252 in Advanced Parkinson\u2019s Disease under 505(b)(2) NDA Pathway”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-878786","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nSerina Therapeutics Announces FDA Feedback\u00a0Supports Registrational Trial Design of SER-252 in Advanced Parkinson\u2019s Disease under 505(b)(2) NDA Pathway - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/serina-therapeutics-announces-fda-feedback-supports-registrational-trial-design-of-ser-252-in-advanced-parkinsons-disease-under-505b2-nda-pathway\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Serina Therapeutics Announces FDA Feedback\u00a0Supports Registrational Trial Design of SER-252 in Advanced Parkinson\u2019s Disease under 505(b)(2) NDA Pathway - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"–\u00a0U.S. IND filing planned for Q4 2025 with U.S. enrollment expected to start in Q1 2026 – Patient dosing expected to begin in Australia in Q4 2025 HUNTSVILLE, AL, Aug. 25, 2025 (GLOBE NEWSWIRE) — Serina Therapeutics, Inc. 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(\u201cSerina\u201d) (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform\u2122\u00a0drug optimization technology,\u00a0today announced that following a recent Type B meeting with the U.S. Food and Drug Administration (FDA), the FDA\u2019s written feedback supports advancing SER-252 (POZ-apomorphine) in a registrational clinical study program in advanced Parkinson\u2019s under the 505(b)(2) NDA pathway. \u201cPeople living with advanced Parkinson\u2019s need more consistent relief from motor fluctuations and our data to date suggest that SER-252 may reliably improve daily function,\u201d said Steve Ledger, Chief … Continue reading \"Serina Therapeutics Announces FDA Feedback\u00a0Supports Registrational Trial Design of SER-252 in Advanced Parkinson\u2019s Disease under 505(b)(2) NDA Pathway\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/serina-therapeutics-announces-fda-feedback-supports-registrational-trial-design-of-ser-252-in-advanced-parkinsons-disease-under-505b2-nda-pathway\/","og_site_name":"Market Newsdesk","article_published_time":"2025-08-25T22:20:33+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTUxNzg0MyM3MTE0ODI0IzUwMDExOTk2NQ==","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"6 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/serina-therapeutics-announces-fda-feedback-supports-registrational-trial-design-of-ser-252-in-advanced-parkinsons-disease-under-505b2-nda-pathway\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/serina-therapeutics-announces-fda-feedback-supports-registrational-trial-design-of-ser-252-in-advanced-parkinsons-disease-under-505b2-nda-pathway\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Serina Therapeutics Announces FDA Feedback\u00a0Supports Registrational Trial Design of SER-252 in Advanced Parkinson\u2019s Disease under 505(b)(2) NDA Pathway","datePublished":"2025-08-25T22:20:33+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/serina-therapeutics-announces-fda-feedback-supports-registrational-trial-design-of-ser-252-in-advanced-parkinsons-disease-under-505b2-nda-pathway\/"},"wordCount":1250,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/serina-therapeutics-announces-fda-feedback-supports-registrational-trial-design-of-ser-252-in-advanced-parkinsons-disease-under-505b2-nda-pathway\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTUxNzg0MyM3MTE0ODI0IzUwMDExOTk2NQ==","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/serina-therapeutics-announces-fda-feedback-supports-registrational-trial-design-of-ser-252-in-advanced-parkinsons-disease-under-505b2-nda-pathway\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/serina-therapeutics-announces-fda-feedback-supports-registrational-trial-design-of-ser-252-in-advanced-parkinsons-disease-under-505b2-nda-pathway\/","name":"Serina Therapeutics Announces FDA Feedback\u00a0Supports Registrational Trial Design of SER-252 in Advanced Parkinson\u2019s Disease under 505(b)(2) NDA Pathway - 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