AL-S Pharma AG, a biotech company jointly founded by Neurimmune and TVM Capital Life Science, announced today enrollment of the first patient in a multicenter, placebo-controlled Phase 2 clinical trial to evaluate AP-101 in patients with amyotrophic lateral sclerosis (ALS).
AP-101 is a human antibody directed against misfolded superoxide dismutase 1 (SOD1).
“We are excited to initiate Phase 2 clinical development of AP-101 and hope to provide therapeutic benefit to patients suffering from Amyotrophic lateral sclerosis,” said Michael Salzmann, AL-S Pharma’s CEO and Neurimmune’s COO. “AP-101 is a human antibody that selectively binds to misfolded and aggregated forms of SOD1. Our goal is to neutralize and remove these abnormal proteins.”
AP-101 has been designed by using genetic information of human memory B cells through Neurimmune’s Reverse Translational Medicine technology. The Phase 2 trial will assess safety, tolerability, pharmacokinetics and pharmacodynamics of AP-101 both in patients with familial ALS with disease-causing SOD1 mutations and in patients with sporadic forms of ALS.
Dr. Angela Genge, Director of the Clinical Research Unit at McGill University in Montreal, and Global PI said: “In general, AP-101 has demonstrated to be safe and well-tolerated in the ongoing Phase 1 single ascending dose study in familial and sporadic ALS patients. Evaluating multiple doses of AP-101 in patients over a time of up to 48 weeks is now an important next step in our efforts to understand the potential of this investigational drug candidate for the treatment ALS.”
Neurimmune and TVM Capital Life Science created AL-S Pharma AG in 2016 to develop AP-101. AL-S Pharma engages with Chorus, a full-service autonomous research and development unit within Eli Lilly and Company, to execute on an innovative clinical plan in collaboration with an international network of ALS experts. Further information on the clinical study of AP-101 for ALS (study number NCT05039099) can be accessed on ClinicalTrials.gov.