Updates from Aptorum Group on Data from Completed Phase 1 Clinical Trial of SACT-1, Targeting Neuroblastoma | national company


Regulatory news:

Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) (“Aptorum Group” or “Aptorum”), a clinical-stage biopharmaceutical company, is pleased to announce finalized data from the Phase 1 clinical trial of SACT-1 , a repurposed small molecule drug targeting neuroblastoma and potentially other types of cancer.

Following the announcement of the Phase 1 clinical trial of SACT-1 in January 2022, Atorum is pleased to announce further updates to the trial data conducted by an independent contracted clinical research organization. The Phase 1 clinical trial of SACT-1 was an open-label, randomized, 3-period, 3-sequence, single-dose, crossover study of bioavailability and dietary effect of SACT-1 (oral suspension) in healthy adult volunteers. health. The primary objective of this study was to evaluate the relative bioavailability of 150 mg of SACT-1 (oral suspension) under fasting and fed conditions. Secondary objectives were to assess the safety, tolerability, and any potential QT interval prolongation after a single oral administration of 150 mg of study drug under fasted and fed conditions in healthy adult subjects. The study treatments were well tolerated and no subject was excluded from study participation due to adverse events. No serious adverse events were reported during the study. Phase 1 clinical data also suggested that any QT interval after oral administration of SACT-1 150 mg was well within clinically acceptable limits. Regarding the relative bioavailability in the Fed vs Fasted condition, the ratios AUC 0-tlast, AUC 0-∞ and C max of SACT-1 were determined as 189.87%, 189.43% and 205.25% respectively.

Dr Clark Cheng, Chief Medical Officer and Chief Executive of Aptorum Group, said: “Following our previous announcements, we are very encouraged by the impressive safety data, even at a relatively high dosage. Relative bioavailability data also allowed us to estimate the starting dose for pediatric patients with neuroblastoma via PK modeling. We plan to meet with the US FDA for an end-of-phase 1 meeting as soon as possible and are targeting a submission for a phase 1b/2a clinical trial in patients with neuroblastoma.

About SACT-1

SACT-1 is a repurposed small molecule drug delivered orally to target neuroblastoma. The mechanism of SACT-1 has been investigated in our preclinical studies to enhance tumor cell death and suppress MYCN expression (a common clinical diagnosis in patients with high-risk or relapsed neuroblastoma where amplification of MYCN is generally observed). SACT-1 is designed to be used especially in combination with standard chemotherapy.

About Atorum Group

Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutic actives to treat diseases with unmet medical needs, particularly in oncology (including including orphan indications in oncology) and infectious diseases. . Aptorum’s pipeline is also enriched by (i) the establishment of drug discovery platforms that enable the discovery of new therapeutic actives, for example through the systematic screening of existing approved drug molecules, and a research platform based on the microbiome for the treatment of metabolic diseases; and (ii) the co-development of a new molecular diagnostic technology for the rapid identification and detection of pathogens with Accelerate Technologies Pte Ltd, the commercialization arm of the Singapore Agency for Science, Technology and research.

For more information about the Company, please 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 buy securities of Atorum Group.

This press release contains statements regarding Atorum 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. To that end, any statements contained herein material that are not statements of historical fact may be deemed to be forward-looking statements. In some instances, you can identify forward-looking statements by words such as “may”, “should”, “expect”, “plan”, “anticipate”, “could”, “intend”. of’, ‘target’, ‘projects’, ‘intends’, ‘believes’, ‘estimates’, ‘predicts’, ‘potential’ or ‘continues’, or the negative form of these terms or other similar expressions. Aptorum Group has based these forward-looking statements, which include statements regarding expected timelines for application submissions and trials, largely on its current expectations and projections regarding 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, without limitation, risks relating to announced changes in management and organization, the ongoing service and availability of key personnel, its ability to expand its product assortments by offering additional products for additional consumer segments, development results, anticipated growth strategies of the business, anticipated business trends and challenges, as well as its expectations regarding and stability of its supply chain, and the risks described in more detail in Atorum Group’s Form 20-F and other documents filed by Atorum Group with the SEC in the future, as well as in the prospectus which received visa n°20-352 from the French Financial Markets Authority on July 16, 2020. By co Accordingly, the projections included in these forward-looking statements are subject to change and actual results may differ materially from those described herein.

Atorum Group undertakes no obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

This press release is not a prospectus within the meaning of Regulation (EU) n°2017/1129 of June 14, 2017 as amended by Delegated Regulations (EU) n°2019/980 of March 14, 2019 and n°2019/979 of March 14, 2019.

This press release is provided “as is” without any representations or warranties of any kind.

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CONTACT: Aptorum Group Limited

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Ghislaine Gasparetto

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SOURCE: Aptorum Group Limited

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PUBLISHED: 05/02/2022 08:00 AM/DISC: 05/02/2022 08:02 AM


Elna M. Lemons