ACM-001 (Espindolol) - previously know as MT-102 - is our lead candidate and is chemically-related to a well-established beta-blocker for hypertension and angina (pindolol). A clinical development programme of ACM-001 (Espindolol) is in planning to confirm and expand upon the positive results demonstrated in a proof of concept Phase II study in patients with cancer-related cachexia.
Mode of action
ACM-001 (Espindolol) is an anabolic/catabolic transforming agent with a multifunctional effect on three key pharmacological targets relevant for cancer cachexia:
•β-1receptor antagonism that blocks catabolism1
• Increased anabolism and muscle growth, through partial β2 receptor agonism1
•Central 5-HT1A antagonism that can stimulate appetite and thereby improve overall patient outcomes as well as improving fatigue2,3,4,5,6,7
This trio of anti-catabolic and pro-anabolic pharmacology makes ACM-001 (Espindolol) a unique candidate for development in cancer cachexia.
The ACT-ONE8 Phase II clinical study of ACM-001 (Espindolol) was a proof of concept exploratory, randomised, double-blind, placebo-controlled study in 87 patients with NSCLC (non-small-cell lung cancer) or colorectal cancer (CRC). The trial demonstrated that ACM-001 (Espindolol) was well-tolerated and that patients receiving high-dose ACM-001 (Espindolol) showed a median weight gain of 2.74kg compared to a median 1.09kg weight loss in patients receiving placebo over a 4-month period.
Patients receiving ACM-001 (Espindolol) also demonstrated improved hand-grip strength.
Actimed now plans to conduct a Phase IIb study programme. The aim of this programme is to obtain further evidence of efficacy and safety, along with dose response, pharmacodynamic and pharmacokinetic data. The results of these studies, if positive, will inform the design of Phase III registration trials.