Actimed Therapeutics Reacquires Global Rights to S-oxprenolol After Faraday Pharmaceuticals Collapse
核心洞察
Actimed Therapeutics (搜索) has regained exclusive worldwide rights to S-oxprenolol following the closure of Faraday Pharmaceuticals (搜索), which ceased operations after its lead drug failed a Phase 3 cardiovascular trial.
S-oxprenolol, an anabolic-catabolic transforming agent, has demonstrated improved survival, body mass, and functional measures in preclinical ALS models and holds FDA orphan drug designation for ALS.
Actimed plans to initiate a clinical development programme for ALS once chemistry, manufacturing, and controls work is completed, while also evaluating the drug's potential in other muscle wasting disorders.
Actimed Therapeutics (搜索) Ltd, a UK-based clinical stage specialty pharmaceutical company, has reacquired exclusive global rights to S-oxprenolol (ACM-002) from Faraday Pharmaceuticals (搜索), Inc., broadening its pipeline opportunities across muscle wasting disorders. The rights reversion follows Faraday's decision to cease operations and begin winding down in February 2026 after its lead drug, FDY-5301, failed a Phase 3 cardiovascular study, missing both its primary and secondary endpoints.
Under the original 2021 licensing agreement, Faraday had acquired worldwide rights to develop and commercialise S-oxprenolol for cancer cachexia (搜索) and all indications outside amyotrophic lateral sclerosis (搜索) (ALS), while Actimed retained rights specifically for ALS. Faraday paid Actimed $550,000 through cash and equity investment, with an additional $2.7 million available as a near-term milestone, and up to $123.5 million in total potential milestones plus royalties. A spokesperson for Actimed confirmed that the return of rights was completed on terms the UK company considers favourable, though financial details of the transaction were not disclosed.
Strategic Consolidation and Pipeline Focus
Robin Bhattacherjee, CEO of Actimed, stated: "We believe S-oxprenolol could have a potential role to play in treating muscle wasting and cachexia associated with ALS, which remains our prime focus with this asset. S-oxprenolol has obtained orphan drug designation for this indication and we plan to initiate a clinical development programme once CMC work for S-oxprenolol is completed. Actimed is also evaluating the full potential of S-oxprenolol in other muscle wasting disorders, and this transaction enhances our strategic flexibility and opportunities around this asset."
The US Food and Drug Administration granted S-oxprenolol orphan drug designation for ALS in August 2024, underscoring the significant unmet need in this ultra-orphan indication.
Mechanism of Action and Preclinical Evidence
S-oxprenolol is an anabolic-catabolic transforming agent (ACTA) designed to act on several biological processes involved in muscle wasting. Dr Fabio Dorigotti, CMO of Actimed, explained: "S-oxprenolol exhibits a multi-modal pharmacology that specifically targets the underlying pathophysiology of muscle wasting disorders, and has demonstrated significant beneficial effects on survival, body mass and functional parameters in a preclinical model of ALS."
Dr Dorigotti further noted that in ALS, "the reduction in quality of life and cause of death for many patients is actually due to muscle wasting and loss of body mass," citing published research on health-related quality of life across ALS disease stages and the impact of respiratory function on mortality in ALS patients. These preclinical findings have not yet been tested in patients.
Broader Pipeline Context
S-oxprenolol remains Actimed's second asset behind S-pindolol benzoate, which has generated promising Phase 2a proof-of-concept data in cancer cachexia (搜索) — a severe wasting syndrome characterized by unintentional weight loss, severe muscle wasting, and loss of fat mass. Actimed has also conducted a pharmacokinetic and pharmacodynamic study of S-pindolol benzoate, and early non-clinical data confirm a potential role for the compound in preserving muscle mass when used in combination with GLP-1 agonists for weight loss.
Cachexia, despite its prevalence in cancer patients and devastating clinical impact, currently has no globally approved therapy for treatment or prevention. In the obesity setting, reductions of lean muscle mass can occur alongside fat loss in patients receiving GLP-1 receptor agonists, highlighting the opportunity for novel approaches that support healthy body composition.
With full worldwide development, manufacturing, and commercialisation rights now consolidated, Actimed gains strategic control over S-oxprenolol across all potential indications, positioning the company to maximise the asset's value as it advances toward clinical development initially focused on ALS.