S-pindolol benzoate (ACM-001) / Actimed Therap - LARVOL DELTA

PROACT: A Study of the Effect of (S)-Pindolol Benzoate (ACM-001.1) on Lean Body Mass (LBM) in Obese Patents During, and Post-semaglutide Therapy (clinicaltrials.gov) - P2 | N=48 | Recruiting | Sponsor: Actimed Therapeutics Ltd

New P2 trial • Genetic Disorders • Obesity

Actimed Therapeutics Expands Intellectual Property Portfolio (GlobeNewswire) - "Actimed Therapeutics...announces today that it has received new patent grants from the United States Patent and Trademark Office (USPTO) and the European Patent Office...Both patents provide protection relating to ACM-001.1 (S-pindolol benzoate), an anti-catabolic and pro-anabolic transforming agent (ACTA) with a multifunctional effect on key pharmacological targets relevant for cancer cachexia and other muscle wasting disorders...European Patent EP 4132909 B covers a pharmaceutically acceptable salt of: (i) S-pindolol; and (ii) benzoic acid; US Patent US 12,109,192 B covers the two preferred crystalline forms of S-pindolol benzoate. "

Patent • Cachexia • Oncology

Actimed Therapeutics Announces Publication of Successful S-pindolol benzoate (ACM-001.1) Phase 1 Study in The Journal of Cachexia, Sarcopenia and Muscle (GlobeNewswire) - P1 | N=51 | NCT06028321 | Sponsor: Actimed Therapeutics Ltd | "Actimed Therapeutics Ltd...announces that results from its Phase 1 pharmacokinetic (PK), pharmacodynamic (PD) and bioavailability study of S-pindolol benzoate (ACM-001.1) in healthy volunteers (NCT06028321) have been published in The Journal of Cachexia, Sarcopenia and Muscle....The study met all pre-defined endpoints, demonstrating that S-pindolol benzoate has predictable pharmacokinetics up to a dose of 15 mg twice daily, with low inter-subject variability after single and multiple doses."

P1 data • PK/PD data • Cachexia

Pharmacokinetics, Pharmacodynamics and Bioavailability of ACM-001.1 (S-Pindolol Benzoate) in Healthy Volunteers. (PubMed, J Cachexia Sarcopenia Muscle) - P1 | "Data from this bridging study of enantiomerically pure ACM-001.1 and its parent racemic drug, pindolol, support clinical trials of ACM-001.1 for the treatment of cancer cachexia."

Journal • PK/PD data • Cachexia • Fatigue • Oncology • Pain

Phase 2B/3 Trial to Study Novel Drug for Cancer-Related Cachexia (Cure Today) - '"Despite the advances in cancer treatment over recent years, there are few treatment options and no new globally approved products for treating cancer cachexia. This places a tremendous burden on patients, their caregivers and families and can have a direct impact on mortality. I am therefore very pleased to be leading the IMPACT US clinical trial program for this potential new treatment in this area of high unmet need', explained Dr. Jose Garcia..."

Media quote

Study of Comparative Bioavailability and Pharmacokinetics of ACM-001.1) and Pindolol in Healthy Volunteers (HV) (clinicaltrials.gov) - P1 | N=51 | Completed | Sponsor: Actimed Therapeutics Ltd

New P1 trial • Cachexia • CXCL5 • CXCL9 • IGF1 • LEP

Actimed Therapeutics announces FDA approval of its Investigational New Drug application for Phase 2b/3 IMPACT clinical trials of S-pindolol benzoate to treat cancer cachexia (GlobeNewswire) - "Actimed Therapeutics Ltd...today announces that it has received approval from the US FDA for its IND application for one Phase 2b/3 clinical study of S-pindolol benzoate (the 'IMPACT' clinical trial programme) to treat cachexia associated with colorectal cancer (IMPACT CRC) and another in patients with non-small cell lung cancer (IMPACT NSCLC)....Actimed has designed the Phase 2b/3 IMPACT clinical trials programme to allow a full evaluation of the safety and efficacy of S-pindolol benzoate, with plans to dose the first trial participant in 2024."

IND • New P2/3 trial • Cachexia • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Metabolic Disorders • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Actimed Therapeutics secures additional £4.75m funding in Series A extension round, almost doubling Series A proceeds (GlobeNewswire) - "Actimed Therapeutics Ltd...today announces it has raised a further £4.75m in an extension to its recent Series A financing round which was completed in June this year...These proceeds will be used to fund the continued development of the Company and will ensure that preparations remain on track for the global Phase 2b/3 IMPACT clinical development programme evaluating its lead asset, S-pindolol benzoate in treating cachexia associated with non-small cell lung cancer and colorectal cancer."

Financing • Cachexia • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Metabolic Disorders • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Actimed Therapeutics secures additional £4.75m funding in Series A extension round, almost doubling Series A proceeds (GlobeNewswire) - P2a | N=87 | ACT-ONE (NCT01238107) | Sponsor: Akamis Bio | "...S-pindolol has demonstrated promising results in an exploratory Phase 2a, proof of concept trial, the ACT-ONE trial, and Actimed has successfully completed a Phase 1 pharmacokinetic/pharmacodynamic (PK/PD) study with S-pindolol benzoate that met all pre-defined objectives..."

P2a data • Trial completion • Cachexia • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Metabolic Disorders • Oncology • Solid Tumor • Thoracic Cancer

Actimed Therapeutics closes over-subscribed Series A Financing Round of £5 million to advance clinical development of lead programme for cancer cachexia (BioSpace) - "Actimed Therapeutics Ltd...announces that it has raised over £5 million in an over-subscribed Series A financing round. This investment will support the development of the Actimed pipeline, including S-pindolol benzoate, with preparations under way for a Phase 2b/3 programme (the 'IMPACT' programme) targeted at the treatment of cancer cachexia in non-small cell lung cancer and colorectal cancer...Proceeds from the financing will be used to further advance the Actimed development portfolio, notably its lead asset S-pindolol benzoate. Actimed is currently completing preparations for regulatory filings of S-pindolol benzoate to support the initiation of the global Phase 2b/3 IMPACT clinical development programme....Actimed aims to close the Series B financing in the second half of 2023."

Financing • New P2/3 trial • Cachexia

Actimed Therapeutics successfully closes second tranche of £10m seed financing to progress pipeline for treatment of cancer cachexia and other muscle wasting disorders (PRNewswire) - "Actimed Therapeutics Ltd...announces completion of its second and final £5 million tranche of seed financing. The round was closed with an investment by Indian pharmaceutical company, Mankind Pharma, marking Mankind's first overseas investment of this type....The financing will support the development of the Actimed portfolio, including preparation for the Phase 2b/3 programme for the Company's lead asset, S-pindolol benzoate, being developed for the treatment of cancer cachexia."

Financing • Cachexia • Oncology

The development of a gut-specific immune response to an oral antigen is dependent on α4β7 mediated lymphocyte trafficking (IMMUNOLOGY 2022) - "α4β7-specific inhibitor, MT-102, effectively diminished the mucosal antibody response to an orally delivered Ag in mice. These results are consistent with what has been reported clinically in vedolizumab-treated subjects and thus establishes that potent small molecule inhibitors of α4β7 can replicate the pharmacology of an antibody."

Cholera • Hepatitis B • Hepatology • Infectious Disease • Inflammation • ITGA4

Actimed Therapeutics Achieves Major Corporate Milestone - Initiation of first clinical study of new salt of S-pindolol (ACM-001.1) (PRNewswire) - “Actimed Therapeutics Ltd announces that following regulatory approval from the UK Regulatory Agency, it has commenced a clinical study in healthy subjects to evaluate the PK and PD of its lead compound, ACM-001.1, a new salt of S-pindolol that is 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. Data from the study are expected in the first half of 2022 and will be used to inform the Phase 2b programme which is planned for late 2022.”

P1 data • Trial status • Cachexia • Oncology