A Parallel Group Treatment, Phase 2a, Double-blind, Two-arm Study to Investigate the Efficacy and Safety of Farudodstat Tablets Compared With Its Placebo in Male or Female Alopecia Areata Participants Aged 18 Years and Older With 30% or Greater Scalp Hair Loss

The main purpose of this study is to measure the efficacy of farudodstat compared to placebo at Week 12 from the treatment start, in adult participants with Alopecia Areata (AA) with 30% or greater scalp hair loss.

Start Date14 Apr 2023

Sponsor / Collaborator

Aslan Pharmaceuticals Ltd.

NCT03451084 / CompletedPhase 2

A Phase IIA Dose Optimisation Study of ASLAN003 in Acute Myeloid Leukemia

ASLAN003-003 is a multi-center, Phase IIA study to evalute the efficacy of ASLAN003 in AML patients who are ineligible for standard treatment with an expansion cohort in relapsed/refractory patients, and to determine the appropriate dose of ASLAN003 in combination with azacitidine in older (more than or equal to 60 years) AML patients who have exhausted any approved and available treatment options.

Start Date05 Jan 2018

Sponsor / Collaborator

Aslan Pharmaceuticals Ltd.

NCT02342652 / CompletedPhase 1

A Phase 1, Randomised, Single Blind, Placebo Controlled, 2-Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASLAN003 in Healthy Elderly Subjects

This is a Phase 1, randomised, single-blind, placebo-controlled, 2 stage study design with 2 multiple dose cohorts of healthy elderly subjects.
The purpose of the study is to determine the safety, tolerability and pharmacokinetics of ASLAN003 in healthy elderly male and female subjects.

Start Date01 Oct 2014

Sponsor / Collaborator

Aslan Pharmaceuticals Ltd.

100 Clinical Results associated with Farudodstat

100 Translational Medicine associated with Farudodstat

100 Patents (Medical) associated with Farudodstat

Literatures (Medical) associated with Farudodstat

01 Dec 2022·European Journal of Medicinal Chemistry

Discovery of potent human dihydroorotate dehydrogenase inhibitors based on a benzophenone scaffold

Article

Author: Luo, Youfu ; Yang, Xiaowei ; Xu, Jing ; Zhao, Yinglan ; Gou, Kun ; Qiu, Zhiqiang ; Zhong, Xi ; Li, Chungen ; Tao, Lei ; Zhou, Yue ; Huang, Zongkai ; Zhou, Yang ; Su, Na ; Liu, Song ; Zeng, Ting ; Zhou, Xia ; Chen, Qiang

Blocking the de novo biosynthesis of pyrimidine by inhibiting human dihydroorotate dehydrogenase (hDHODH) is an effective way to suppress the proliferation of cancer cells and activated lymphocytes. Herein, eighteen teriflunomide derivatives and four ASLAN003 derivatives were designed and synthesized as novel hDHODH inhibitors based on a benzophenone scaffold. The optimal compound 7d showed a potent hDHODH inhibitory activity with an IC₅₀ value of 10.9 nM, and displayed promising antiproliferative activities against multiple human cancer cells with IC₅₀ values of 0.1-0.8 μM. Supplementation of exogenous uridine rescued the cell viability of 7d-treated Raji and HCT116 cells. Meanwhile, 7d significantly induced cell cycle S-phase arrest in Raji and HCT116 cells. Furthermore, 7d exhibited favorable safety profiles in mice and displayed effective antitumor activities with tumor growth inhibition (TGI) rates of 58.3% and 42.1% at an oral dosage of 30 mg/kg in Raji and HCT116 cells xenograft models, respectively. Taken together, these findings provide a promising hDHODH inhibitor 7d with potential activities against some tumors.

02 Nov 2018·Expert Opinion on Therapeutic Targets

The emergence of dihydroorotate dehydrogenase (DHODH) as a therapeutic target in acute myeloid leukemia

Author: Sykes, David B.

A review.The enzyme dihydroorotate dehydrogenase (DHODH) is essential for the de novo production of pyrimidines starting with the generation of uridine monophosphate (UMP), and small mol. inhibitors of DHODH are highly effective in vitro and in vivo in pre-clin. models of malignancy.The use of DHODH inhibitors in solid tumor malignancies has been clin. disappointing, and however, the use of DHODH inhibitors in the treatment of acute myeloid leukemia (AML) has been more recently shown to have both a cytotoxic and a pro-differentiation effect, making AML an attractive new disease indication.With the promise that AML cells may be particularly sensitive to pyrimidine starvation, there has been renewed interest in the clin. development of DHODH inhibitors.The phase I trials of BAY2402234 (Bayer, NCT03404726) and ASLAN003 (Aslan Pharmaceuticals, NCT03451084) are currently underway with other companies (Agios, PTC Therapeutics) likely to be entering the clin. arena.

HaematologicaQ1 · MEDICINE

ASLAN003, a potent dihydroorotate dehydrogenase inhibitor for differentiation of acute myeloid leukemia

Q1 · MEDICINE

Article

Author: Seet, Qihui ; Lin, Baohong ; Hosoi, Hiroki ; Lindmark, Bertil ; Yiying Quah, Jessie ; Zea Tan, Tuan ; Hui-Min Toh, Sabrina ; Zhou, Jianbiao ; Chooi, Jing-Yuan ; Chng, Wee-Joo ; Osato, Motomi ; Ng, Yvonne ; McHale, Mark ; Ooi, Lisa A G

Differentiation therapies achieve remarkable success in acute promyelocytic leukemia, a subtype of acute myeloid leukemia. However, excluding acute promyelocytic leukemia, clinical benefits of differentiation therapies are negligible in acute myeloid leukemia except for mutant isocitrate dehydrogenase 1/2. Dihydroorotate dehydrogenase catalyses the fourth step of the de novo pyrimidine synthesis pathway. ASLAN003 is a highly potent dihydroorotate dehydrogenase inhibitor that induces differentiation, as well as reduces cell proliferation and viability, of acute myeloid leukemia cell lines and primary acute myeloid leukemia blasts including in chemo-resistant cells. Apoptotic pathways are triggered by ASLAN003, and it also significantly inhibits protein synthesis and activates AP-1 transcription, contributing to its differentiation promoting capacity. Finally, ASLAN003 substantially reduces leukemic burden and prolongs survival in acute myeloid leukemia xenograft mice and acute myeloid leukemia patient-derived xenograft models. Notably, the drug has no evident effect on normal hematopoietic cells and exhibits excellent safety profiles in mice, even after a prolonged period of administration. Our results, therefore, suggest that ASLAN003 is an agent targeting dihydroorotate dehydrogenase with potential in the treatment of acute myeloid leukemia. ASLAN003 is currently being evaluated in phase 2a clinical trial in acute myeloid leukemia patients.

News (Medical) associated with Farudodstat

17 Jul 2024

·www.fiercebiotech.com

Aslan’s dream of challenging Dupixent dies as cash-strapped biotech winds down

All positions at the biotech have been terminated “effective immediately.” Aslan Pharmaceuticals had bold ambitions to challenge Sanofi and Regeneron's immunology blockbuster Dupixent, but now the cash-strapped biotech has run out of road. The California and Singapore-based biotech, which had cash and equivalents of $18.4 million as of the end of March, said it had “conducted a thorough review of all strategic alternatives” before deciding it had no option but to file for voluntary liquidation. For the biotech’s staff, it means all positions have been terminated “effective immediately,” the company said. The appointed liquidators will be responsible for winding up Aslan’s affairs, as well as searching for options for the biotech’s two main assets: the IL-13-targeting eblasakimab and the dihydroorotate dehydrogenase inhibitor farudodstat. Despite some mixed data on doses last year, Aslan had maintained high hopes for eblasakimab to challenge Sanofi and Regeneron’s atopic dermatitis blockbuster Dupixent. As recently as May, the biotech was pointing to positive interim data from a small, 22-patient phase 2 study that it said “showed unprecedented efficacy data compared to prior atopic dermatitis studies with biologics.” Aslan also said at the time that it was on track for a full readout for this study by the end of 2024, with an interim readout from a mid-stage trial of farudodstat in alopecia areata expected in the second quarter. The company didn’t give an estimate on how long it expected its $18.4 million to last, but the operational burn rate of $7.4 million for the first three months of the year suggested more money was needed soon. Despite these plans, the writing appeared to be on the wall for Aslan on Monday, when the company announced that it wouldn’t appeal Nasdaq’s decision to delist the biotech. In the past year, Aslan’s stock has shed 95% of its value, dropping from $22 per share in July 2023 to a closing price on Tuesday of just $1.10.

Phase 2Clinical Trial FailureClinical ResultFinancial Statement

17 Jul 2024

·www.globenewswire.com

ASLAN Pharmaceuticals Announces it Has Filed for Voluntary Liquidation of Its Sole Operating Subsidiary and is Commencing Steps to Place Itself Into Voluntary Liquidation

Following a thorough review of all strategic alternatives, ASLAN Pharmaceuticals Pte Ltd, the sole operating subsidiary of ASLAN Pharmaceuticals, has filed for voluntary liquidation Quantuma (Singapore) Pte Limited International has been appointed as the official liquidator and will seek potential strategic alternatives for the Company’s development programs, eblasakimab and farudodstat SAN MATEO, Calif. and SINGAPORE, July 17, 2024 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (“ASLAN” or the “Company”), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced that its Singapore-incorporated, sole operating subsidiary, ASLAN Pharmaceuticals Pte Ltd (“ASLAN SG”), has filed for voluntary liquidation. The decision follows a comprehensive review by the Board of the Company of ASLAN SG’s financial position and strategic alternatives. Effective immediately, all employees of ASLAN SG and fellow subsidiary ASLAN Pharmaceuticals (USA) Inc. have been terminated. By a resolution in writing passed by the directors of ASLAN SG on July 17, 2024, it was resolved that ASLAN SG cannot by reason of its liabilities continue its business, and Mr Luke Anthony Furler and Mr Tan Kim Han of Quantuma (Singapore) Pte Limited were appointed as joint and several provisional liquidators (“Provisional Liquidators”) of ASLAN SG. The Provisional Liquidators will be responsible for the orderly winding up of ASLAN SG’s affairs, including seeking potential strategic alternatives for its development programs and the Company’s primary assets, eblasakimab and farudodstat, settling outstanding obligations, and distributing any remaining proceeds, if any, to creditors and shareholders, including the Company, in accordance with Singaporean law. Following the resolution in writing of the directors of ASLAN SG, the Board of the Company also resolved by a resolution in writing that the Company cannot by reason of its liabilities continue its business and that the Company will apply for liquidation under Cayman law procedures. As previously disclosed on July 15, 2024, the Company has received a staff delisting determination from the Nasdaq Stock Market due to its failure to meet continued listing requirements, and determined not to request a hearing before the Nasdaq Hearings Panel. As such, the Company expects its American Depository Shares (“ADSs”) will be suspended from trading in due course with trading moved to the over-the-counter market. Forward looking statements This release contains forward-looking statements. These statements are based on the current beliefs and expectations of the management of the Company. These forward-looking statements may include, but are not limited to, statements regarding the trading price of the Company’s ADSs. 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 orderly winding up, 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, the Company’s orderly winding up process, as well as unexpected safety or efficacy data observed during preclinical or clinical studies; risks that future clinical trial results may not be consistent with interim, initial or preliminary results or results from prior preclinical studies or clinical trials; clinical site activation rates or clinical trial enrollment rates that are lower than expected; the impact of health epidemics or pandemics, or geopolitical conflicts on the Company’s operations, research and development and clinical trials and potential disruption in the operations and business of third-party manufacturers, contract research organizations, other service providers and collaborators with whom the Company conducts business; general market conditions; and changes in the competitive landscape. 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 U.S. 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 U.S. Securities and Exchange Commission on April 12, 2024. 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. Contact Luke Furler Quantuma International Phone: (SG) +65 9821 4124/ (HK) +852 8170 3838 Email: Luke.Furler@quantuma.com

Executive Change

15 Jul 2024

·www.globenewswire.com

ASLAN Pharmaceuticals Announces Receipt of Nasdaq Delisting Determination; Has Determined Not to Appeal

SAN MATEO, Calif. and SINGAPORE, July 15, 2024 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (“ASLAN” or the “Company”, Nasdaq: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced that on July 9, 2024, the Company was notified by the staff of the Listing Qualifications Department (the "Staff") of The Nasdaq Stock Market LLC ("Nasdaq") that, based upon the Company’s non-compliance with the $1.00 bid price and $2.5 million stockholders’ equity requirements for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Listing Rules 5550(a)(2) and 5550(b)(1), respectively, the Staff had determined to delist the Company’s securities from Nasdaq. Upon consideration by the Company’s board of directors, the Company has determined not to request a hearing before the Nasdaq Hearings Panel. As previously disclosed, on January 5, 2024, the Staff notified the Company that the bid price for the Company’s American Depositary Shares (“ADSs”) had closed below the minimum $1.00 threshold for the previous 30 consecutive business days. In accordance with the Nasdaq Listing Rules, the Company was provided a 180 calendar day period, through July 3, 2024, to regain compliance with the bid price requirement. As also disclosed, on April 18, 2024, the Staff notified the Company that it no longer satisfied the stockholders’ equity requirement of $2.5 million, and the Company was provided with the opportunity to address the deficiency and submit a compliance plan for the Staff’s review, which the Company timely submitted. As previously disclosed, effective July 3, 2024, the Company changed the ratio of its ordinary shares, par value $0.01 per share, from one (1) ADS representing twenty-five (25) ordinary shares to one (1) ADS representing two hundred (200) ordinary shares, which resulted in a closing price in excess of $1.00 per ADS. As of the date of this press release, the bid price for the Company’s ADSs closed above the minimum $1.00 threshold for five consecutive business days. In order to evidence full compliance, the Company’s bid price must close at or above $1.00 per ADS for a minimum of ten, though generally not more than, 20 consecutive business days. 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 currently investigating eblasakimab in dupilumab-experienced, moderate-to-severe AD patients in the TREK-DX Phase 2 trial 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. 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 the Company. These forward-looking statements may include, but are not limited to, statements regarding the trading price of the Company’s ADSs. 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; risks that future clinical trial results may not be consistent with interim, initial or preliminary results or results from prior preclinical studies or clinical trials; clinical site activation rates or clinical trial enrollment rates that are lower than expected; the impact of health epidemics or pandemics, or geopolitical conflicts on the Company’s operations, research and development and clinical trials and potential disruption in the operations and business of third-party manufacturers, contract research organizations, other service providers and collaborators with whom the Company conducts business; 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 and maintain its listing. 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 U.S. 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 U.S. Securities and Exchange Commission on April 12, 2024. 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. ASLAN Media and IR contacts Emma ThompsonSpurwing CommunicationsTel: +65 6206 7350 Email: ASLAN@spurwingcomms.comAshley R. RobinsonLifeSci Advisors, LLCTel: +1 (617) 430-7577Email: arr@lifesciadvisors.com

Phase 2Clinical Result

100 Deals associated with Farudodstat

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16049

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Alopecia Areata	Phase 2	US	Aslan Pharmaceuticals Ltd.	14 Apr 2023
Acute Myeloid Leukemia	Phase 2	-	Almirall SA	-
Inflammatory Bowel Diseases	Phase 1	-	Aslan Pharmaceuticals Ltd.	01 Mar 2022
Skin Diseases	Phase 1	-	Aslan Pharmaceuticals Ltd.	01 Mar 2022
Autoimmune Diseases	Phase 1	SG	ASLAN Pharmaceuticals Pte Ltd.	30 Jan 2022
Rheumatic Fever	Phase 1	-	Almirall SA	-
Rheumatic Fever	Phase 1	-	Aslan Pharmaceuticals Ltd.	-
Multiple Sclerosis	Discovery	ES	Almirall SA	27 Aug 2008
Rheumatoid Arthritis	Discovery	SG	Aslan Pharmaceuticals Ltd.	-
Rheumatoid Arthritis	Discovery	ES	Almirall SA	-

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03451084 (CTgov)	Phase 2	Acute Myeloid Leukemia	24	ASLAN003 (Part 1: ASLAN003 100mg QD)	(uylvkujguz) = fwpzfhqdvj llkyyltejz (oslpzcmjym, xtikosiiwn - bwjwbyrlvk) View more	-	02 Jul 2021
				ASLAN003 (Part 1: ASLAN003 200mg QD)	(uylvkujguz) = tcticaftgn llkyyltejz (oslpzcmjym, dvxncayfet - geuxdqvyqx) View more

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