Actimed Therapeutics Receives FDA Approval for Phase 2b/3 IMPACT Clinical Trials Evaluating S-pindolol Benzoate as a Treatment for Cancer Cachexia
Friday, September 08, 2023
Actimed Therapeutics Ltd, a UK-based pharmaceutical company with a focus on innovative treatments for cancer cachexia and muscle wasting disorders, has received approval from the US FDA for its Investigational New Drug (IND) application. This approval paves the way for Phase 2b/3 clinical trials of S-pindolol benzoate as part of the IMPACT clinical trial program. These trials will target cachexia associated with colorectal cancer (IMPACT CRC) and non-small cell lung cancer (IMPACT NSCLC).
Cachexia is a recognized complication of cancer, contributing to as much as 20% of cancer-related deaths. Unfortunately, weight loss in cancer patients is often not addressed adequately, and there are currently no globally approved treatments for this patient group, highlighting the urgent need for effective new therapies.
S-pindolol has shown promising results in a Phase 2a proof-of-concept trial known as the ACT-ONE trial. Actimed has also successfully completed a pharmacokinetic/pharmacodynamic (PK/PD) study with S-pindolol benzoate (ACM-001.1), meeting all predetermined objectives. These objectives included demonstrating the absence of in vivo conversion from S-pindolol to R-pindolol and establishing that S-pindolol benzoate is essentially bioequivalent to the S-pindolol found in racemic pindolol, with dose-dependent pharmacokinetics after single and multiple doses.
S-pindolol benzoate's anti-catabolic and pro-anabolic properties position it as a promising new therapy for cancer cachexia. Actimed has meticulously designed the Phase 2b/3 IMPACT clinical trials program to thoroughly assess the safety and efficacy of S-pindolol benzoate, with plans to enroll the first trial participant in 2024.
Dr. Jose Garcia, MD, PhD, Professor of Medicine at the University of Washington School of Medicine and Director of the Geriatric Research Educational and Clinical Centre (GRECC) at the Puget Sound Veterans Affairs Healthcare System, who serves as the US Principal Investigator for the IMPACT trial program, emphasized the importance of addressing cancer cachexia. He pointed out the lack of treatment options and globally approved products, which places a significant burden on patients, caregivers, and families and can impact mortality rates. Dr. Garcia expressed his enthusiasm for leading the IMPACT US clinical trial program for this potential new treatment in an area of high unmet need.
Elaine Morten, PhD, Head of Regulatory Affairs and Technical Development for Actimed Therapeutics, highlighted the significance of the FDA's approval of their first IND application. This milestone will enable Actimed to move forward with their planned clinical studies on S-pindolol benzoate. The company intends to seek additional clinical trial approvals in other major regions, provided they secure the necessary funding, to expedite the completion of the IMPACT studies.
Earlier this year, Actimed began preparations to formally launch its Series B financing round. This funding round is aimed at supporting the IMPACT clinical program until completion, with assistance from WG Partners, a London-based Life Sciences advisory firm, which is actively involved in the Series B financing process.
