Aslan Pharmaceuticals Ltd (NASDAQ:ASLN) recently announced the shift to the third dose cohort of its developmental atopic dermatitis treatment called ASLAN004 as part of ongoing clinical trials.
The decision to move on to the third dose cohort was made after the immunology biopharma received a green light from the Data Monitoring Committee (DMC). The latter gave its recommendation for the continuation of the multiple ascending doses (MAD) as part of the clinical study after it completed a planned safety data review.
Aslan has already started enrolling participants into the third dose cohort which is the highest dose cohort in which patients will be treated with 600mg of ASLAN004. The MAD study will still be placebo-controlled, double-blind, and randomized. The company plans to recruit 8 subjects into the clinical trial which will be conducted at different sites in Australia, Singapore, and the U.S. The immunology biopharma expects to release the interim results of all the three cohorts early next year.
“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,” stated Aslan Pharmaceuticals’ Chief Medical Officer, Dr. Ken Kobayashi.
How Aslan conducts the dose cohorts
Aslan managed to enroll eight patients into the study after the easing of COVID19 restrictions which previously made it impossible to conduct the study. The company conducted the second cohort study at two sites and a total of eight patients were enrolled. The company plans to use up to 9 sites for the third dose cohort. Dr. Kobayashi also noted that ASLAN004 is highly promising as a treatment for atopic dermatitis. He also added that the company expects to report more data from ongoing studies especially as it plans to move to the Phase 2b study next year.
The phase 1 study featured three dose cohorts where patients were treated with 200mg of ASLAN004 in the first cohort, 400mg in the second cohort and the third cohort will feature 600mg. Each cohort has six patients treated with ASLAN004 while two patients are treated with a placebo. The studies aim to determine the dose efficacy, safety, and tolerability profiles of each dose after dosing for 8 weeks.