Aptorum Announces Publication of a Co-authored Paper on Development and Validation of a Sensitive Liquid Chromatography with Time-Of-Flight Mass Spectrometry Assay for In Vivo Pharmacokinetic Study of Epigallocatechin-gallate octaacetate (Pro-EGCG)


NEW YORK & LONDON & PARIS, November 25, 2022–(BUSINESS WIRE)–Regulatory News:

Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM), a clinical-stage biopharmaceutical company focused on addressing unmet medical needs in oncology, autoimmune and infectious diseases, is pleased to announce the recent publication announce a joint effort for the developed validated analytical method for the determination of plasma pro-EGCG and its metabolites after oral administration using high-performance liquid chromatography coupled to quadrupole time of flight mass spectrometry. This method proved to be robust, fast and sensitive, which is a prerequisite for performing in vivo pharmacokinetic studies.

The article is titled: “Determination of (-)-epigallocatechin-3-gallate octaacetate and its metabolites in plasma of rats for pharmacokinetic study by ultra-performance-liquid-chromatography coupled to quadrupole-time-of-flight-mass-spectrometry” is published in Frontiers in Pharmacology, which is available for download at the following website address: https://pubmed.ncbi.nlm.nih.gov/36304154/.

Dr. Thomas Lee, Aptorum Group’s Head of Research and Development commented: “We are pleased that this test has been developed through our collaboration with the Chinese University of Hong Kong. Pro-EGCG is a prodrug of EGCG via octa-acetylation. As expected, it will be metabolized into EGCG in multiple steps and therefore monitoring these metabolites at the same time is very challenging Many thanks to our collaborators, especially Prof. Ronald Chi Chiu Wang, at the Chinese University of Hong Kong, for their hard work towards a sensitive, robust LC/MS assay that can monitor multiple Pro-EGCG and its metabolites in plasma. Developing a sensitive assay is a necessary step before conducting in vivo IND studies, such as GLP-compliant pharmacokinetic and toxicokinetic studies. We believe that the same assay can be further optimized for potential Phase 1 clinical trials in humans.”

About Aptorum’s Pro-EGCG Program

Pro-EGCG is a novel small molecule designed for oral administration as a potential non-hormonal treatment for endometriosis. The condition endometriosis is a painful condition in which the endometrial tissue grows outside the uterus, potentially affecting the ovaries, fallopian tubes, and pelvic tissues, and in severe cases affecting fertility. It is estimated that endometriosis affects c. 10% of women and girls of childbearing age according to the World Health Organization1.

1. https://www.who.int/news-room/fact-sheets/detail/endometriosis#:~:text=Endometriosis%20affects%20roughly%2010%25%20(190,and%20girls%20globally%20 (2).

About Aptorum Group

Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of therapeutic assets for the treatment of diseases with unmet medical needs, particularly in oncology ( including orphan oncology indications), autoimmune and infectious diseases. Aptorum has completed two Phase I clinical trials for its ALS-4 (MRSA) and orphan drug named SACT-1 (Neuroblastoma) small molecule drugs and the commercialization of its NLS-2 NativusWell® nutraceutical (menopause). Aptorum’s pipeline is also enriched by (i) the establishment of drug discovery platforms that enable the discovery of novel therapeutics through, for example, systematic screening of existing approved drug molecules, and a microbiome-based research platform for the treatment of metabolic diseases ; and (ii) the joint development and ongoing clinical validation of its novel molecular technology for rapid identification and detection of molecular-based pathogens with the Singapore Agency for Science, Technology and Research.

For more information about the company, visit www.aptorumgroup.com.

Disclaimer and Forward-Looking Statements

This press release does not constitute an offer to sell or a solicitation of offers to purchase securities of Aptorum Group.

This press release contains statements about Aptorum Group Limited and its future expectations, plans and prospects that constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995. For this purpose, all statements that are not statements of historical fact are included herein. may be considered forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may”, “should”, “expects”, “intends”, “anticipates”, “could”, “intends”, “target”, “projects, “contemplates”, “believes”, “estimates”, “predicts”, “potentially” or “proceeds”, or the negation of these terms or other similar expressions. Aptorum Group has based these forward-looking statements, including statements regarding expected timelines for filing and trials, largely on its current expectations and projections about future events and trends that it believes may affect its business, financial condition and results of operations . These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, risks associated with announced management and organizational changes, the continued service and availability of key personnel, its ability to expand its product range by offering additional products for additional consumer segments, development achievements, the Company’s anticipated growth strategies, anticipated trends and challenges in its business, and its supply chain expectations and stability, and the risks more fully described in Aptorum Group’s Form 20-F and other documents that Aptorum Group may file with the SEC in the future, as well as the prospectus that has been issued the French Autorité des Marchés Financiers Visa No. 20-352 on July 16, 2020 receive. As a result, the projections in such forward-looking statements are subject to change and actual results may differ materially from those described herein.

Aptorum Group disclaims any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

This announcement is not a prospectus within the meaning of Regulation (EU) No 2017/1129 of 14 June 2017 as amended by Delegated Regulations (EU) No 2019/980 of 14 March 2019 and No 2019/979 of 14 March 2019.

This press release is provided “as is” without any representation or warranty of any kind.

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