Eyeing a New Finish Line: ABSK-021's Initial Trial Faces Delays
- Abbisko Therapeutics, a Chinese biotech company developing small molecule oncology therapies, revealed a significant delay in the Phase 1 trial studying the safety of ABSK-021 for patients with advanced solid tumors. At this time, they are aiming for an enrollment of 85 individuals.
- This trial, originally scheduled to wrap up by December 31, 2022, is now set for December 31, 2023. Such setbacks are not uncommon in the industry and might suggest challenges in recruitment, the investigational compound's performance, or overall trial management.
Further Developments with ABSK-021 by Abbisko:
- Abbisko is conducting Phase 2 and Phase 3 trials to assess the efficacy and safety of ABSK-021 for advanced solid tumors and Tenosynovial Giant Cell Tumor (TGCT). These trials, involving 175 patients, are distributed across 32 global facilities.
- The company's drug, Pimicotinib, previously earned the FDA's breakthrough therapy designation for TGCT treatment, based on encouraging phase Ib trial outcomes. This accolade underscores a pivotal progress in Abbisko's international R&D efforts.
- Notably, Pimicotinib, an innovative CSF-1R inhibitor crafted by Abbisko, showcases versatility with potential therapeutic applications in multiple diseases. It had also secured the Breakthrough Therapy Drug certification from China’s NMPA in July 2022.
- Projected completion dates for the trials are December 31, 2023, for the mid-stage and May 01, 2026, for the late-stage.
A Glimpse at Abbisko's Diverse Clinical Front
- The Changai based company is also delving deeper into several other investigational compounds such as ABSK-011 and Atezolizumab. The research on ABSK-011 seeks to conclude by July 20, 2024, and for Atezolizumab, outcomes are awaited by December 31, 2023.
- Other compounds like AZD4547 and ABSK091 are under review with respective conclusions targeted for August 14, 2023, and April 30, 2021.
Advanced Solid Tumors Frontline: Who Are the Other Emerging Players?
- Deciphera Pharmaceuticals LLC emerges as a prominent competitor in advanced solid tumors research. They're advancing with a Phase 3 trial for Vimseltinib and a Phase 2 trial for DCC-3014.
- Their late-stage study is projected to conclude by March 01, 2024, and their mid-stage investigation is targeting December 01, 2023. With giants like Abbisko and Deciphera in the race, it underscores the area's immense therapeutic potential and demand.
Sources: Clinicaltrials.gov, PubMed, Press Releases, and AppliedXL. This report is generated algorithmically and may not cover all ongoing industry-sponsored trials. AppliedXL implements rigorous AI vetting processes but cannot guarantee the completeness of all insights.