• The Phase 2a, proof-of-concept study, called FAST-AA (FArudodstat STudy in Alopecia Areata), will enroll approximately 60 adult patients in the US; interim topline readout is expected in 1Q 2024
• Farudodstat is a potent, oral DHODH inhibitor with the potential to be a novel, first-in-class treatment for alopecia areata (AA)

SAN MATEO, Calif. and SINGAPORE, May 18, 2023 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (NASDAQ: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced that it has dosed the first patient in a Phase 2a proof-of-concept study of farudodstat, an oral dihydroorotate dehydrogenase (DHODH) inhibitor, in adult patients with severe alopecia areata (AA), an autoimmune condition causing hair loss. The study, called “FAST-AA” (FArudodstat STudy in Alopecia Areata), will investigate farudodstat’s efficacy and safety in patients with at least 50% scalp hair loss.

“We are excited to begin this trial investigating farudodstat in AA, a disease for which patients have very limited treatment options,” said Dr Alex Kaoukhov, Chief Medical Officer of ASLAN Pharmaceuticals. “DHODH is an established target in the treatment of autoimmune diseases, and data from our recent studies support farudodstat’s potential to treat AA. The human translational data we presented as a late-breaking abstract at the first International Societies for Investigative Dermatology (ISID) meeting earlier this month showed that farudodstat not only reduced T cell proliferation but may also protect from immune privilege collapse, potentially offering a novel mechanism for AA treatment.”

Dr Kaoukhov continued, “FAST-AA will enroll patients in at least 20 sites across the US with a topline readout from the first 12-week treatment period expected in 1Q 2024.”

“The burden of disease experienced by AA patients can be comparable to, or even greater than, that experienced with atopic dermatitis and psoriasis, yet only one systemic treatment has been approved to date in AA,” said Dr Brett King, Associate Professor of Dermatology at Yale School of Medicine and an investigator in FAST-AA. “Hence clinical development of novel therapies is crucial in AA and could significantly benefit patients. As a mediator of T cell proliferation, Dihydroorotate dehydrogenase, or DHODH, has the potential to be a novel target in AA, and I am excited to see this trial move forward.”

About FAST-AA

“FArudodstat STudy in Alopecia Areata” (FAST-AA) is a Phase 2a proof-of-concept trial evaluating the efficacy and safety of farudodstat in patients with at least 50% scalp hair loss due to AA. Patients will be randomized in a 2:1 ratio to receive either farudodstat or placebo, orally, twice daily for 12 weeks. Following this initial treatment, patients will crossover to the other arm for an additional 12 weeks of treatment, followed by a 4-week safety follow-up. The study is expected to enroll approximately 60 adult patients across at least 20 sites in the US. The primary efficacy endpoint will utilize the Severity of Alopecia Tool (SALT) for clinical assessment and evaluate percentage change in SALT score from baseline to week 12. Key secondary endpoints to be studied include the proportion of patients achieving a SALT score ≤ 20 and the proportion of patients achieving SALT50 and SALT75 at week 12.

About farudodstat

Farudodstat is a potent, oral dihydroorotate dehydrogenase (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 alopecia areata (AA).

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. Eblasakimab is being investigated in a global Phase 2b trial of moderate-to-severe AD patients with topline readout expected in early July 2023. ASLAN is also developing farudodstat, a potent oral inhibitor of the enzyme dihydroorotate dehydrogenase (DHODH) as a potential first-in-class treatment for alopecia areata (AA) in a Phase 2a proof-of-concept trial with an interim readout expected in 1Q 2024. ASLAN has teams in San Mateo, California, and in Singapore. For additional information please visit the 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 Company’s plans to develop and commercialize farudodstat; the safety and efficacy of farudodstat; the Company’s plans and expected timing with respect to clinical trials, clinical trial enrolment and clinical trial results for farudodstat; the potential of farudodstat as a first-in-class treatment for alopecia areata; and the Company’s cash runway. 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; clinical site activation rates or clinical trial enrolment rates that are lower than expected; the impact of the COVID-19 pandemic or the ongoing conflict between Ukraine and Russia and bank failures 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 “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “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.

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