UK-based Actimed Therapeutics is planning to start two Phase IIb/III trials of its lead candidate for the treatment of cancer cachexia in H1 2024, said CEO Robin Bhattacherjee in an interview with Pharmaceutical Technology.
The company plans to raise funding in a Series B round to the tune of “significantly more” than £10m ($15.66m) in H2 2023, which will finance both studies in cancer cachexia, a wasting syndrome that results in cancer patients losing their body fat and weight.
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By GlobalDataIf all goes to plan, the trials will start in H1 2024, he confirmed.
To date, Actimed has engaged individual investors during the company’s seed and Series A rounds and has raised more than £15m ($19.58m), he added.
The company is developing ACM-001.1 or S-pindolol benzoate, an anabolic and catabolic transforming agent that can be used for the treatment of cancer cachexia. The drug increases anabolism and muscle growth while reducing catabolism, per Actimed’s website. It also improves appetite and reduces fatigue.
Originally, Actimed studied ACM-001, also known as S-pindolol, in a Phase IIa proof-of-concept trial. The company has since developed a new, more stable form of the drug called ACM-001.1.
Actimed expects to enrol more than 300 patients in each of the two trials. A part of the IMPACT programme, the trials will focus on patients with non-small cell lung cancer (NSCLC) and colorectal cancer.
The company will file an investigational new drug (IND) application with the US Food and Drug Administration (FDA) once more details are finalised.
Bhattacherjee said that the company will be looking at the composition of body weight, rather than just its increase while using the rate of weight change as a primary or coprimary endpoint.
He added that a simple increase in body weight due to water retention would not represent a clinically meaningful benefit for the patients. Actimed will carefully look at the increase in lean muscle mass and improvements in that area as a key measure of efficacy.
However, it is likely the biotech will opt for additional coprimary endpoints and will “almost certainly” have a functional endpoint.
The trials will feature a significant number of sites in the US and Western Europe. This strategy slightly bucks the trend of looking at sites in regions such as Eastern Europe. This is due to the company wanting all patients to have a background of receiving the most up-to-date cancer treatments.
Bhattacherjee noted that this means that recruitment will likely be quicker in the US and Western Europe.
