ASLAN PHARMACEU/ADR (NASDAQ: ASLN) shares are trading at sub-$1 levels following a clinical readout from the company.
Aslan, which went public in May 2018, said its varlitinib, codenamed ASLAN001, failed in a pivotal study dubbed TreeTopp that evaluated the asset for biliary tract cancer.
The multinational study evaluated 127 patients who failed first-line therapy. Topline data showed that varlitinib did not meet the co-primary endpoints of progression-free survival, or PFS, and overall response rate, or ORR, as assessed by ICR according to RECIST.
The median PFS was 2.83 months for varlitinib in combination with the chemotherapy drug capecitabine compared to 2.79 months for the control arm, Aslan said.
The ORR was 9.4% in the treatment arm compared to 4.8% for the control arm, the company said.
Why It's Important
Aslan's lead asset is varlitinib, and it is in the most advanced stage of clinical development in the second-line setting for biliary tract cancer.
It is also being evaluated in separate midstage trials in the second-line setting for gastric cancer and in the first-line setting for biliary tract cancer.
"The results from the study are disappointing. They will, however, provide the scientific community with important insights into an aggressive and under-researched disease that presents a growing burden of care worldwide as prevalence rises," Aslan CEO Dr. Carl Firth said in a statement.
Pre-planned exploratory analysis identified a sub-group showing improved efficacy, Aslan said.
This finding has been supported by a retrospective review of the JADETREE study, which evaluated the varlitinib-chemo combo in second-line biliary tract cancer patients in China, the company said.
Aslan said it expects to release interim data from the Phase 1 study of its IL-13 receptor ASLAN004 in atopic dermatitis in early 2020.
Aslan shares were plunging 58.11% to 87 cents at the time of publication.
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