ASLAN Pharmaceuticals Initiates Third Dose Cohort of ASLAN004 in Atopic Dermatitis Clinical Trial


Deprecated: strlen(): Passing null to parameter #1 ($string) of type string is deprecated in /home/medicircle/public_html/script_newsdetails.php on line 75
▴ ASLAN Pharmaceuticals Initiates Third Dose Cohort of ASLAN004 in Atopic Dermatitis Clinical Trial
ASLAN has now initiated recruitment into the third, highest dose (600mg) cohort of the randomised, double blind, placebo-controlled MAD study.

ASLAN Pharmaceuticals (Nasdaq:ASLN), a clinical-stage immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced that the Data Monitoring Committee (DMC) has completed its planned safety data review of the second dose cohort of its clinical trial of ASLAN004 in moderate to severe atopic dermatitis (AD) patients. ASLAN004 was found to be well tolerated at 400mg and the DMC has recommended that the multiple ascending dose (MAD) clinical study continue as planned.

ASLAN has now initiated recruitment into the third, highest dose (600mg) cohort of the randomised, double blind, placebo-controlled MAD study. A total of eight patients will be recruited from clinical sites in Singapore, the US and Australia. ASLAN expects to report interim, unblinded data from all three dose escalation cohorts in early 2021.

Dr Ken Kobayashi, Chief Medical Officer, ASLAN Pharmaceuticals, commented: “Importantly, ASLAN004 continues to be well tolerated in the patients treated in the study to date and no discontinuations of treatment related to study drug have been observed. Following the lifting of recruitment restrictions associated with COVID-19 that had previously delayed the study, we were pleased to note that the second dose cohort enrolled all eight patients in around three weeks at two clinical sites. For the third dose cohort, we will be recruiting patients from up to nine sites, having activated new sites in Australia and the US. We believe that ASLAN004 has the potential to be a best-in-disease treatment for patients with AD and look forward to reporting further data and firming up our plans to initiate a Phase 2b study in 2021.”

The Phase 1 study is evaluating three doses of ASLAN004 (200mg, 400mg and 600mg) delivered subcutaneously and will include a fourth (expansion) cohort. Each dose cohort contains up to six patients on ASLAN004 and two patients on placebo, and the expansion cohort will contain at least 12 patients on ASLAN004 and at least six patients on placebo. Patients are dosed weekly for eight weeks to determine safety and tolerability as well as a number of secondary efficacy outcome measures.

ASLAN004 is a first-in-class monoclonal antibody that binds to the IL-13 receptor α1 subunit (IL-13Rα1), blocking signalling of two pro-inflammatory cytokines, IL-4 and IL-13, which are central to triggering symptoms of AD, such as redness and itching of the skin.

About ASLAN Pharmaceuticals
ASLAN Pharmaceuticals (Nasdaq:ASLN) is a clinical-stage immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients. Led by a senior management team with extensive experience in global development and commercialisation, ASLAN has a clinical portfolio comprised of a first-in-class monoclonal therapy, ASLAN004, that is being developed in atopic dermatitis and other immunology indications, and ASLAN003, which it plans to develop for autoimmune disease. For additional information please visit www.aslanpharma.com.

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, the Company’s plans to develop and commercialise ASLAN004, the safety and efficacy of ASLAN004, the potential for ASLAN004 to deliver a best-in-disease treatment for people with atopic dermatitis, and the Company’s plans and expected timing with respect to enrolment in its clinical trials for ASLAN004 and clinical trial results for ASLAN004. 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 these risks and uncertainties, which include, without limitation the risk factors described in the Company’s U.S. Securities and Exchange Commission filings and reports (Commission File No. 001-38475), including the Company’s Form 20-F filed with the U.S. Securities and Exchange Commission (the “SEC”) on April 16, 2020.

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.

Tags : #ASLAN #NASDAQ #DOUBLEBLIND #DRKENKOBAYASHI #DMC

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

Richest 1% people have enough new wealth to end annual poverty 22 times overJuly 11, 2025
Fermenta Signs Strategic MoU with NIFTEM-T to Strengthen India’s Food Fortification LandscapeJuly 11, 2025
Sarvodaya Hospital, Greater Noida West, Launches Next-Gen Fully Active Robotic System for Joint ReplacementJuly 10, 2025
Children Dazzle the Stage at Faridabad Talent Hunt at Asian Institute of Medical SciencesJuly 10, 2025
From Macro to Mandate: How India's Affluent Investors are Positioning for Global ShiftsJuly 10, 2025
Actress-turned-Entrepreneur raises alarm over hidden pet health crisis in IndiaJuly 10, 2025
Aster CMI Performs Complex Tracheal Resection and Anastomosis to Cure Chronic BreathlessnessJuly 10, 2025
CARE Hospitals, Hitech City introduces India’s Most Advanced AI-Powered Robotic Surgery SystemJuly 09, 2025
Nestlé India Supports Flood Relief Efforts in Himachal PradeshJuly 09, 2025
When Machines Whisper Care: The Quiet Rise of Medical Bots in Elderly WardsJuly 09, 2025
Integrating mental health into India’s primary healthcare, what’s next?July 09, 2025
Where the Mind Finds Rest: How Green Spaces Quiet the City NoiseJuly 09, 2025
Can a Smartphone Heal Your Wound?July 09, 2025
University of Birmingham Dubai invites applications for MSc in Financial Data ScienceJuly 08, 2025
Benefits of ShirodharaJuly 07, 2025
WIKA India Launches “Re-Inventing Hygiene” Campaign to Advance Standards in Food & Pharma InstrumentationJuly 07, 2025
Cambodia is 2nd Asian country to rollout long-acting injectable HIV prevention optionJuly 07, 2025
Wheels of Care: How Tele-MRVs Are Reaching Mothers Left BehindJuly 07, 2025
Personalized Psychiatry's Developing Use of PharmacogenomicsJuly 07, 2025
Honourable Ministers Shri Anil Kumar Bachoo and Shri Palanivel Thiaga Rajan Open IIRSI 2025 Convention on Intraocular Implant & Refractive SurgeryJuly 05, 2025