S-pindolol, our lead candidate is an anabolic/catabolic transforming agent1. A clinical development programme for our new form of S-pindolol (ACM.001.1) is in planning to confirm and expand upon the positive results demonstrated in a proof of concept, Phase 2a trial, ACT-ONE, in patients with cancer-related cachexia.
Mode of action
S-pindolol (ACM-001) 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 S-pindolol (ACM-001) a unique candidate for development in cancer cachexia.
The ACT-ONE8 Phase II clinical study of S-pindolol (ACM-001) 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 S-pindolol (ACM-001) was well-tolerated and that patients receiving high-dose S-pindolol (ACM-001) 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 S-pindolol (ACM-001) also demonstrated improved hand-grip strength.
Actimed has initiated its first clinical study of the pharmacokinetics and pharmacodynamics (PK/PD) for a new salt of S-pindolol (ACM-001.1) under development as a treatment for cancer cachexia. The study will be conducted in healthy subjects in two parts. It will compare ACM-001.1 to pindolol and will investigate both single and multiple dose PK and assess a range of doses of ACM-001.1. This study is a prelude to the commencement of a Phase IIb clinical programme in patients and the results from this data, if positive, will be used to inform the Phase IIb programme.