ASLAN Pharmaceuticals Receives Favorable Opinion From the European Patent Office on Composition of Matter Patent Application for Farudodstat

  • New Composition of Matter Patent for farudodstat would strengthen intellectual property protection and provide commercial exclusivity for farudodstat until at least 2043

SAN MATEO, Calif. and SINGAPORE, Feb. 29, 2024 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals Ltd. (Nasdaq: ASLN), a clinical-stage, immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced it has received a favorable patentability opinion from the European Patent Office (EPO) acting as the International Examiner on a polymorph patent application for farudodstat which, if granted in the national stages, will extend effective patent protection for farudodstat until at least 2043.

Farudodstat is a potent, oral dihydroorotate dehydrogenase (DHODH) inhibitor with the potential to be a first-in-class treatment option for alopecia areata (AA). ASLAN is currently conducting a Phase 2a proof-of-concept trial in AA (the “FAST-AA Study”) and an interim readout from the study is expected mid-2024.

“We are very pleased to have received a positive preliminary opinion from the EPO on the Composition of Matter patent application for farudodstat, and recognition that all of our claims were novel and inventive. If granted in the national stages, the new patent will extend the patent protection on farudodstat until at least 2043. This will significantly enhance the commercial exclusivity of farudodstat and is an important achievement in our plans to strengthen the patent protection for farudodstat in all key commercial territories. With so few treatment options available to alopecia areata patients, our ambition is to bring a safe and effective treatment option to patients,” said Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals.

About farudodstat

Farudodstat is a potent, oral DHODH inhibitor that suppresses immune cell proliferation and IFN-γ secretion by blocking de novo production of pyrimidines required for DNA replication. Compared to first-generation DHODH inhibitors, farudodstat has been shown to be approximately 30 times more potent in its inhibition of DHODH and T cell activity and has demonstrated a well-tolerated safety profile. ASLAN has generated data showing that farudodstat can potentially protect against the loss of immune privilege in hair follicles, supporting its potential as a first-in-class treatment option for AA. A Phase 2a proof-of-concept trial in AA, the FAST-AA study, is currently underway with an interim readout expected mid-2024.

About ASLAN Pharmaceuticals

ASLAN Pharmaceuticals (Nasdaq: ASLN) is a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients. ASLAN is developing eblasakimab, a potential first-in-class antibody targeting the IL-13 receptor in moderate-to-severe atopic dermatitis (AD) with the potential to improve upon current biologics used to treat allergic disease, and has reported positive topline data from a Phase 2b dose-ranging study in moderate-to-severe AD patients. ASLAN is also developing farudodstat, a potent oral inhibitor of the enzyme DHODH as a potential first-in-class treatment for AA in a Phase 2a, proof-of-concept trial with an interim readout expected mid-2024. ASLAN has teams in San Mateo, California, and in Singapore. For additional information please visit the ASLAN website or follow ASLAN on LinkedIn.

Forward-looking statements

This release contains forward-looking statements. These statements are based on the current beliefs and expectations of the management of ASLAN Pharmaceuticals Limited and/or its affiliates (the "Company"). These forward-looking statements may include, but are not limited to statements regarding the Company’s business strategy and clinical development plans; the term of the Company’s patent protection; the Company’s plans to develop and commercialize eblasakimab and farudodstat; the safety and efficacy of eblasakimab and farudodstat; the Company’s plans and expected timing with respect to manufacturing activities, clinical trials, clinical trial enrolment and clinical trial results for eblasakimab and farudodstat; the potential of eblasakimab as a first-in-class treatment for atopic dermatitis and of farudodstat as a first-in-class treatment for alopecia areata; the potential benefits, capabilities and results of the Company’s collaboration efforts. The Company’s estimates, projections and other forward-looking statements are based on management's current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations, or financial performance, and inherently involve significant known and unknown risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of many risks and uncertainties, which include, unexpected safety or efficacy data observed during preclinical or clinical studies; the fact that results of earlier studies and trials may not be predictive of future trial results; clinical site activation rates or clinical trial enrolment rates that are lower than expected; the impact of the COVID-19 pandemic, the ongoing conflict between Ukraine and Russia, as well as ongoing conflicts in the Middle East on the Company’s business and the global economy; general market conditions; changes in the competitive landscape; and the Company’s ability to obtain sufficient financing to fund its strategic and clinical development plans. Other factors that may cause actual results to differ from those expressed or implied in such forward-looking statements are described in the Company’s US Securities and Exchange Commission filings and reports (Commission File No. 001- 38475), including the Company’s Annual Report on Form 20-F filed with the US Securities and Exchange Commission on March 24, 2023. All statements other than statements of historical fact are forward-looking statements. The words “may,” “could,” “will,” “estimate,” “anticipate,” “intend,” “expect,” “plan,” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes are intended to identify estimates, projections, and other forward-looking statements. Estimates, projections, and other forward-looking statements speak only as of the date they were made, and, except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement.

Media and IR contacts

Emma Thompson
Spurwing Communications
Tel: +65 6206 7350
Ashley R. Robinson
LifeSci Advisors, LLC
Tel: +1 (617) 430-7577

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