SCHLIEREN, Switzerland – 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 ALS,” 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 MedicineTM 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.
Neurimmune is a biopharmaceutical company translating human immune memory into transformative antibody therapeutics. Neurimmune develops drug candidates for CNS and related protein aggregation diseases including Alzheimer’s disease, amyotrophic lateral sclerosis, frontotemporal dementia, dementia with Lewy bodies and ATTR cardiomyopathy. Neurimmune discovered aducanumab, a human monoclonal antibody targeting aggregated amyloid beta, together with a team of researchers at the University of Zurich and licensed it to Biogen. With its Reverse Translational MedicineTM (RTMTM) technology, Neurimmune also discovered the anti-tau antibody BIIB076 for Alzheimer’s disease, the anti-miSOD1 antibody AP-101 for ALS and the anti-ATTR antibody NI006 for ATTR cardiomyopathy, programs being currently evaluated in clinical trials. Neurimmune has three additional antibody programs in preclinical development and has recently expanded the spectrum of its treatment modalities by adding a small molecule program and programs involving vectorized expression of human antibody genes.
About TVM Capital Life Science
TVM Capital Life Science is providing venture capital to the international pharmaceutical, biopharmaceutical and medical technology industries with more than 35 years of transatlantic investment track record and more than US $2.0B raised. With its advisory, corporate finance and investment teams located in Montreal and Munich, the TVM Capital Life Science team provides investors, as well as entrepreneurs and innovation-seeking biopharmaceutical companies, access to global life science innovation and provides paths for successful tech transfer and commercialization for the benefit of patients and investors alike.
The TVM Capital Life Science team looks back on more than 140 investments and over 100 exits, including more than 45 initial public offerings on all major U.S. and European stock exchanges. The team has gained unrivalled international investment and business development experience with their track record of dedicated board work, significant contribution to global networks in the world of life science research and product development, and a direct knowledge of the local markets.
About AL-S Pharma AG
AL-S Pharma AG is a special purpose company created to develop AP-101 to proof-of-concept. The project is fully financed by TVM Life Science Ventures VII and Neurimmune. AL-S Pharma is led by an experienced management team and the Board of Directors comprises Guy Rouleau, director of McGill University’s Montreal Neurological Institute (MNI) and Hospital, Chair Department of Neurology and Neurosurgery, McGill University, Hubert Birner, Managing Partner, TVM Capital Life Science, Munich, Marc Riviere, General Partner, TVM Capital Life Science, Montreal, Christoph Hock (CMO of Neurimmune AG) and Jan Grimm (CSO of Neurimmune AG).
This press release contains forward-looking statements about TVM Life Science Ventures VII’s investment in a Phase 2 clinical stage compound for the treatment of ALS that is being developed by AL-S Pharma AG. It reflects TVM’s current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development. There is no guarantee TVM will realize the expected benefits of the transaction, that the product will receive regulatory approval, or if approved, would be commercially successful. TVM undertakes no duty to update forward-looking statements.
Martin Meier-Pfister, +41 43 244 8140
Neurimmune & AL-S Pharma:
Dr. Michael Salzmann, +41 44 755 4607
COO of Neurimmune, acting CEO of AL-S Pharma AG