Policy & Regulation
ChemomAb Releases Data from Phase 1 Study of CM-101 Subcutaneous Formulation Demonstrating Comparable Exposure to The Intravenous CM-101 Formulation
22 August 2019 - - Israel-based clinical-stage biopharmaceutical company ChemomAb Ltd has released results from its Phase 1 single administration study evaluating the subcutaneous formulation of CM-101 in healthy volunteers, the company said.

This study is the second phase I study conducted with CM-101, the first study was a single ascending dose 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 humanised monoclonal antibody 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.

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 patients using the SC formulation, which is a more suitable administration mode for this indication.

The company's lead investigational drug candidate CM-101 is a fully humanized monoclonal antibody targeting the chemokine CCL24, an important driver of fibrotic processes that was tested pre-clinically in various animal models of fibrotic disorders.

This 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.
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