TEL AVIV, Israel--(BUSINESS WIRE)--ChemomAb Ltd., a clinical-stage biopharmaceutical company focused on the development of novel therapies for fibrotic-inflammatory diseases, announced results from its Phase 1 single administration study evaluating the subcutaneous (SC) formulation of CM-101 in healthy volunteers. This study is the second phase I study conducted with CM-101, the first study was a single ascending dose (SAD) study using the IV formulation. In both studies, 40 healthy volunteers received a single dose of either IV or SC CM-101 versus placebo followed by 42 days of follow up.
CM-101, is a fully humanized monoclonal antibody (mAb) targeting the chemokine CCL24 that is in clinical development for the treatment of patients with liver fibrotic diseases such as NASH and Primary Sclerosing Cholangitis (PSC).
The data demonstrate that similar dose levels of the SC and IV formulations yielded a comparable exposure, half-life, safety, tolerability and target engagement. Both formulations support a once in 3 weeks dosing. ChemomAb intends to use the data from this Phase 1 study to explore multiple administrations of CM-101 in non-alcoholic steatohepatitis (NASH) patients using the SC formulation, which is a more suitable administration mode for this indication.
“Based on the data presented, we believe that the SC formulation could serve as a more convenient and flexible administration mode for NASH patients while maintaining an adequate drug exposure and pharmacodynamic effect,” said Adi Mor, Chief Executive Officer of ChemomAb. “The impressive safety profile of both the IV and SC formulation and the similarity in the exposure profile between the two formulations is a significant finding that will enable a straightforward progression towards Ph2 studies in NASH using the SC formulation.”
The company’s lead investigational drug candidate CM-101 is a fully humanized monoclonal antibody (mAb) targeting the chemokine CCL24, an important driver of fibrotic processes that was tested pre-clinically in various animal models of fibrotic disorders. The drug completed two phase I studies using and IV and SC formulations and is currently being tested in a Ph1b trial in NAFLD patients to be followed by a cohort of NASH patients. In parallel the drug is planned to be tested in Phase 2 studies in PSC and Systemic Sclerosis.
ChemomAb is a clinical stage biopharmaceutical company, specializing in the development of proprietary monoclonal antibodies, directed towards novel targets, for the treatment of fibrotic-inflammatory disorders including NASH, as well as the orphan indications Primary Sclerosing Cholangitis and Systemic Sclerosis. The antibodies are designed to treat patients with fibrotic and inflammatory diseases through a novel dual mechanism of action that interferes with fibrosis processes directly as well as attenuates the inflammatory process that supports the fibrotic milieu and disease progression. The company’s lead investors include OrbiMed and Peter Thiel.