NA-941™ for Metabolic dysfunction-associated steatohepatitis (MASH)

Metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis or NASH) is a type of fatty liver disease. It often develops due to a metabolic disorder, such as obesity or diabetes, resulting in a toxic buildup of fat in the liver.

NA-941™ regulates the homeostasis of insulin-like growth factor (IGF-1) function associated with fatty liver disease.

NA-941 is a small molecule drug that is in Phase 2/3 clinical trials for the treatment of metabolic dysfunction-associated steatotic liver disease.

NA-941 can easily cross the blood brain barrier, so only a small dose of the drug is required to be effective. The drug shows the following properties:

* NA-941™ exhibits neuroprotection

* NA-941 regulates IGF-1 and GLP-1

* It has great bioavailability in the body

* It is very safe, with no toxicity observed

* It has shown a proof of safety and efficacy for the treatment of metabolic dysfunction-associated steatohepatitis

* It is available in oral formulation: convenient, one capsule once a day.

Some Statistics:

Over the study period from 1988 to 2016, the prevalence of chronic hepatitis B and alcoholic liver disease remained stable: 0.3%–0.4% and 0.8%–1.0%, respectively (p>0.05).

The prevalence of chronic hepatitis C decreased nearly twofold: 1.6% in 1988–1994 to 0.9% in 2013–2016 (p=0.03).

In contrast, the prevalence of non-alcoholic fatty liver disease (NAFLD) or Metabolic dysfunction-associated steatohepatitis (MASH) increased from 20.0% (1988–1994) to 28.3% (1999–2004) to 33.2% (2009–2012) and 31.9% (2013–2016) (p<0.0001).

Furthermore, steady increases were observed in the rates of obesity (22.2% in 1988–1994 to 31.0% in 1999–2004 to 38.9% in 2013–2016), type 2 diabetes mellitus (T2DM) (from 7.2% to 8.2% to 13.5% same years), insulin resistance and hypertension (all p<0.0001).

Conclusions: Over the past 30 years in the USA, MASH is the only liver disease with growing prevalence, synchronous with the increasing rates of obesity and T2DM.

The Phase 2A clinical trials of NA-941 have been designed to evaluate its safety and efficacy as required by the US Food and Drug Administration (FDA) and other regulators overseas before being approved for usage and marketing worldwide.