Pipeline

Indication

Candidate

Discovery

Preclinical

Phase 1

Phase 2

Pivotal

IV — Intravenous

SC — Subcutaneous

Primary Sclerosing Cholangitis

Candidate

Discovery

Preclinical

Phase 1

Phase 2

Pivotal

CM-101

Primary Sclerosing Cholangitis (PSC) is a chronic progressive cholestatic disease of the liver characterized by inflammation and strictures of the biliary tree inside and/or outside the liver. The pathological hallmarks of PSC include injury to the integrity of the biliary ducts, retention of bile acids and intrahepatic inflammation and progressive liver fibrosis.

Disease Prevalence and Comorbidities

PSC is a rare disease, with a prevalence of 1 out of 10,000, and is more prevalent in men compared to women (2:1 ratio). Peak age at onset of PSC is between 30 and 40 years. PSC patients frequently present with concomitant inflammatory bowel disease (up to 75%), and are at increased risk of developing hepatobiliary and colon cancers. More than 50% of PSC patients need liver transplantation within 10–15 years of diagnosis.

Current Treatment Options

There is no approved drug for treating PSC, therefore current treatment focuses on reductions of cholestasis and management of disease manifestations and complications (e.g., fatigue, pruritis).

CM-101: Scientific Findings

Chemomab established strong pre-clinical evidence that demonstrates the potent anti-cholestatic and anti-fibrotic effects of CM-101 in PSC. Specifically:

  • The overexpression of CCL24 and its correlation with fibrotic biomarkers was demonstrated in liver tissue samples and sera of PSC patients
  • CM-101 attenuated cholestasis and fibrosis in multiple PSC animal models

CM-101 was found to be safe and well tolerated in healthy volunteers and patients with nonalcoholic fatty liver disease (NAFLD) across doses and throughout multiple administrations.

Systemic Sclerosis

Candidate

Discovery

Preclinical

Phase 1

Phase 2

Pivotal

CM-101

Systemic Sclerosis (SSc), also called scleroderma, is a rare, chronic autoimmune disease that is characterized by chronic inflammation, fibrosis of the skin and internal organs as well as vascular damage. SSc involves multiple internal body organs and the symptoms of the disease vary depending on the affected organs and extent of damage.

Disease Prevalence and Comorbidities

Peak age at onset of SSc is between 20 and 50 years, and it is more prevalent in women compared to men, at a 3:1 ratio. There are two forms of SSc:

  • Limited cutaneous SSc, which is a slowly progressive disease with skin involvement restricted to the limbs and characterized by delayed-onset organ damage
  • Diffuse cutaneous SSc, which is a more aggressive form of the disease that presents a widespread skin damage and risks rapid-onset organ damage, including effects on the kidneys, heart, lungs and gastrointestinal tract

Although SSc is considered rare, with an estimated prevalence of approximately 1 in 10,000, it has high morbidity and mortality. The prognosis varies significantly among people affected and is correlated to the extent of organ damage. Unfortunately, SSc has the highest mortality rate among the systemic rheumatic diseases with pulmonary damage being the main cause of death.

Current Treatment Options

One therapy is approved for slowing the rate of decline in pulmonary functions in patients with SSc associated with interstitial lung disease (SSc-ILD). Currently, there is no therapy approved for SSc beyond this manifestation. Current treatment is therefore directed at suppression of the immune system or management of specific disease manifestations (e.g., digital ulcers, pulmonary hypertension).

CM-101: Scientific Findings

Chemomab demonstrated the key role of CCL24 and the substantial anti-fibrotic effects of CM-101 in SSc, namely:

  • In the sera and skin tissue samples of SSc patients, overexpression of CCL24 correlates with lung function deterioration
  • CM-101 prevention and treatment normalizes fibrosis in experimental skin and lung animal models
  • CM-101's direct anti-fibrotic and anti-inflammatory mechanism of action (MoA) was demonstrated in multiple ex-vivo and in-vitro studies

CM-101 was found to be safe and well tolerated in human across doses and throughout multiple administrations.

Liver Fibrosis MoA (SC Formulation)

Candidate

Discovery

Preclinical

Phase 1

Phase 2

Pivotal

CM-101