AL-S Pharma prepares Phase 3 trial for active substance against ALS

(CONNECT) AL-S Pharma presented its Phase 2 results for its investigational antibody therapy AP-101 at the 36th International Symposium on ALS/MNC in San Diego, California. It is intended to halt the progression of amyotrophic lateral sclerosis (ALS), an incurable degenerative disease of the motor nervous system that is associated with increasing muscle weakness and muscle atrophy. The average survival time is around three to five years.

AL-S Pharma's human monoclonal antibody AP-101 is directed against sporadic ALS and a specific genetic cause of ALS, namely the mutation in the superoxide dismutase 1 (SOD1) gene. The global Phase 2 study with 73 participants confirmed the safety and tolerability of the antibody, according to a statement from AL-S Pharma. Early treatment with the antibody prolonged the survival time and delayed the need for ventilation. This was accompanied by a stabilization of the disease.

"Despite the statistical limitations of a Phase 2 study, the exploratory outcome data suggest that treatment with AP-101 results in a clinically meaningful treatment effect in both sporadic ALS and SOD1-ALS patients," Medical Director Dr. Angela Genge is quoted as saying. According to the information provided, AL-S Pharma is currently preparing the further clinical phase 3 trial.

"We are determined to advance a much-needed new treatment option for ALS," says CEO Dr. Michael Salzmann. All participants "pioneered a new disease-modifying approach by targeting misfolded SOD1 with a therapeutic antibody".

AL-S Pharma was founded in 2016 by the biotech company Neurimmune and the Canadian venture capital fund TVM Capital Life Science from Montreal and has since been financed by both to bring AP-101 to market maturity. AL-S Pharma is based at its parent company Neurimmune. The company, which was spun off from the University of Zurich in 2006, is based in the Bio-Technopark Schlieren-Zurich. ce/mm