- The stock price of Aslan Pharmaceuticals Ltd (NASDAQ: ASLN) fell by over 25%. This is why it happened.
The stock price of Aslan Pharmaceuticals Ltd (NASDAQ: ASLN) – a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients – fell by over 25%. The drop in the stock price comes as a surprise since it happened after the company reported positive topline data from its randomized, double-blind, placebo-controlled, 8-week, multiple-ascending-dose (MAD) Phase 1 study of ASLAN004 for the treatment of moderate-to-severe atopic dermatitis (AD).
This appears to be a case of “buy the rumor, sell the news” situations for investors. In cases like that, stocks trade up as the potential for a big announcement becomes highly anticipated and then sells off shortly after.
ASLAN004 — a potential first-in-class monoclonal antibody that targets the IL-13 receptor — was shown to be well tolerated across all doses. And the data from the study conclusively establishes proof of concept and supports the potential of ASLAN004 as a differentiated novel treatment for AD.
In March 2021, ASLAN had announced interim data from three dose-escalation cohorts, then continued to enroll and treat an additional 27 patients in an expansion cohort at the highest dose (600mg). The results announced today compare results from all patients receiving 600mg to all receiving placebo (n=39). And the Intent to Treat (ITT) population (n=38) comprised patients from 10 sites and represented all patients dosed excluding one patient that discontinued from the study prematurely due to COVID-19 restrictions.
ASLAN004 had achieved a statistically significant improvement (p<0.0251) versus placebo in the primary efficacy endpoint of percent change from baseline in the Eczema Area Severity Index (EASI) and also showed significant improvements (p<0.051) in other key efficacy endpoints: EASI-50, EASI-75, peak pruritus and the Patient-Oriented Eczema Measure (POEM).
After discussions with the Data Monitoring Committee prior to unblinding, a Revised ITT population (RITT, n=29) was defined to exclude one study site at which all patients enrolled in the study appeared atypical of moderate-to-severe AD patients based on biomarkers, such as TARC, and patient medical history. In the RITT population — which is more comparable to other published studies3 in moderate-to-severe AD, ASLAN004 also achieved a statistically significant improvement (p<0.0251) versus placebo in percent change from baseline in EASI and showed a greater improvement over placebo in the key efficacy endpoints versus the ITT population.
These are the key study results
— In the RITT population, the average reduction from baseline in EASI at 8 weeks was 65% (n=16) compared to 27% (n=13) for patients on placebo (p=0.0211).
a.) 69% achieved EASI-75 versus 15% on placebo (p=0.0051);
b.) 44% of patients achieved Investigator’s Global Assessment (IGA) of 0 or 1 versus 15% on placebo (p=0.1071).
— In the 32 patients that completed at least 29 days of dosing across all sites, defined in the protocol as the efficacy evaluable data set, the average reduction from baseline in EASI at 8 weeks was 73% (n=19) compared to 44% (n=13) for patients on placebo (p=0.0071).
— The proportion of patients with adverse events and treatment-related adverse events were similar across treatment and placebo arms. There were no incidences of conjunctivitis in the expansion cohort.
“We’re delighted to report such positive data on ASLAN004. The data from the study wholly support our view that ASLAN004’s novel mechanism could represent a new treatment option for patients suffering with moderate-to-severe AD, with the potential to deliver best-in-class efficacy and best-in-class safety. We look forward to building upon this strong data set as we initiate the Phase 2b study in the coming weeks and explore monthly dosing regimens that could provide additional convenience to patients.”
— Dr Ken Kobayashi, Chief Medical Officer, ASLAN Pharmaceuticals
“Atopic dermatitis is one of the most common dermatological diseases worldwide and presents with a range of symptoms that have a tremendous negative impact on a patient’s quality of life. Patients, especially those with moderate-to-severe disease, are still in great need of novel treatment options that are safe, efficacious and convenient to use to overcome the limitations of options currently available to them. The findings from the study show the potential benefit that ASLAN004 could offer patients in achieving almost completely clear skin and relief from the burden of atopic dermatitis on daily life.”
— Dr Steven Thng, Principal Investigator
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