On January 30, 2019 ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage oncology-focused biopharmaceutical company developing novel therapeutics for global markets, reported a strategic corporate restructuring to focus its resources on its lead clinical programs: varlitinib in biliary tract cancer (BTC), ASLAN003 in acute myeloid leukaemia (AML) and ASLAN004 in atopic dermatitis (Press release, ASLAN Pharmaceuticals, JAN 30, 2019, View Source [SID1234532971]).
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ASLAN will focus its resources on the late-stage development of varlitinib as a potential novel treatment for first- and second-line BTC. Enrolment in a global pivotal study of varlitinib in second-line BTC, the TreeTopp (TREatmEnT OPPortunity) study, was completed ahead of schedule in December 2018 and topline data is expected in the second half of 2019. ASLAN will be closing the ongoing single-arm second-line BTC study in China as it is now expected to read out after the TreeTopp study. If positive, data from the TreeTopp study will be used to submit a New Drug Application (NDA) in China, the US and other major geographies.
ASLAN recently reported positive phase 1b results from an ongoing study of varlitinib as a first-line treatment for BTC which demonstrated that varlitinib increased objective response rate compared to standard of care and this study will continue to recruit patients to strengthen this dataset.
The clinical development of ASLAN003 in AML and ASLAN004 in atopic dermatitis remains on track. ASLAN expects to complete the first part of the phase 2 study of ASLAN003 in AML and the phase 1 SAD study of ASLAN004 in the first half of 2019.
Following this strategic review, ASLAN will reduce its cost base, including a reduction in headcount by 30%. In total, the planned changes will lower operational costs by 50%. ASLAN does not expect to incur any material restructuring charges.
In addition to the reduction in headcount, Dr Bertil Lindmark, currently Chief Medical Officer, has announced he will retire and return to Europe. Dr Chih-Yi Hsieh, currently VP Medical and GM Taiwan, will assume the role of acting Chief Medical Officer. Dr Mark McHale, Chief Operating Officer, will transition to the role of Chief Development Officer and Head of R&D with immediate effect.
Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: "We remain committed to ensuring the most effective use of capital to support the development of our three key assets, varlitinib, ASLAN003 and ASLAN004, each of which have the potential to be critical value-drivers. We are approaching several significant milestones in 2019 and beyond, so it is important we complete key studies over the next two years. Restructuring the organisation has involved some tough decisions. It is difficult to lose outstanding members of the team who have contributed to ASLAN over the years and have tackled some of the most challenging obstacles to advancing new treatments for cancer."