Our first Phase 2-ready drug candidate will be developed for nonalcoholic steatohepatitis (NASH). Its novel mechanism of action reduces liver fat content, a surrogate marker for NASH progression.

 

What is NASH?

 

NASH is a condition of fat deposition and inflammation of the liver. It is the second largest cause of advanced liver disease. In the next decade, NASH will surpass hepatitis C to become the most common reason for liver transplant. It is also a significant risk factor for cardiovascular morbidity and mortality. The World Gastroenterology Organization estimates mortality rates among NASH patients of 1.6-6.8% for advanced liver disease, and 12.6-36% for cardiovascular disease.

 

Who has NASH?

  

In a cohort of U.S. adults, NASH was confirmed by histology in 12.2%.  It is similarly prevalent in Europe and Japan, as well as in developing nations such as China and India. But few people know they have NASH.

 

Type 2 diabetes (T2D), obesity, hypertension and dyslipidemia are each associated with increased NASH prevalence. It is associated with consumption of a Western diet high in fructose and polyunsaturated fats. The risks of NASH progression and mortality increase in older patients and in patients with comorbid T2D. NASH can be found in people without any known risk factors.

 

How is NASH treated?

 

No drugs have regulatory approval for NASH.

 

Several available drugs were tested in NASH patients.

  • High-dose vitamin E improves liver histology in non-diabetic adults with NASH, but is not recommended to treat NASH in diabetic patients.

  • Pioglitazone, a T2D medication, can be used to treat NASH. The clinical trials that investigated pioglitazone for NASH treatment enrolled mostly non-diabetics and did not establish long-term safety and efficacy in NASH patients.

  • Metformin, the most commonly prescribed T2D medication has no significant effect on liver histology, and is not recommended as treatment for NASH.

  • Dietary supplements are either not recommended (ursodeoxycholic acid), or don’t yet have sufficient evidence of benefit (omega-3 fatty acids), for NASH.

 

Among drugs in development, the most advanced is obeticholic acid. It is expected to start Phase 3 clinical trials in 2015.

 

How will Sparrow Pharmaceuticals differentiate our NASH product?

 

Most drugs in development target the late stages of NASH, when extensive fibrosis or cirrhosis is present. There is particular need for novel drugs with potential to reverse the earlier stages of steatosis and inflammation, preventing progression to late stage disease. Our Phase 2-ready drug candidate has potential to reverse steatosis and inflammation in earlier stages of NASH.

 

Most drugs in development do not have independent benefit for T2D, which is comorbid in many NASH patients. There is particular need for novel drugs with potential to treat both NASH and T2D. A compound with the same mechanism of action as our Phase 2-ready drug candidate showed clinical efficacy similar to current branded T2D medications.

 

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