Interim Report January-September 2020
Abliva is interested in partnering its innovative primary mitochondrial disorders portfolio to advance these programs as effectively as possible. The company can consider different partnering models, depending on what is optimal for our programs and partners.
Abliva’s candidate drug NeuroSTAT is in clinical phase II development for treatment of moderate to severe traumatic brain injury. It has orphan drug designation in both Europe and the US, and an IND approval for further clinical development in the US. In addition, in July 2019, NeuroSTAT received Fast Track designation from the FDA. The company can consider different partnering models, depending on what is optimal for our programs and partners.
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Non-alcoholic fatty liver disease (NAFLD) affects 20-25 percent of the global population. When fat deposits in the liver are combined with inflammation and scar tissue (fibrosis), the disease has progressed to non-alcoholic steatohepatitis (NASH) – a condition that may lead to liver cirrhosis or hepatocellular carcinoma (liver cancer). An estimated 20 percent of people with NAFLD have NASH and there is a strong link between NASH and other metabolic syndromes such as diabetes and obesity. There are no approved drugs for treating NASH at the present time, but with forthcoming treatments, the NASH market is expected to exceed USD 25 billion, globally, by 2026.1)
NV556 is a candidate drug with a directly acting anti-fibrotic mechanism of action targeting NASH patients who have progressed from the initial metabolic stage characterized by fat storage and inflammation. NV556 is a potent cyclophilin inhibitor derived from Abliva’s Sangamide class of compounds. The anti-fibrotic effect can also be developed for other diseases involving liver fibrosis, such as Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC). Preclinical results have shown that the greatest potential for the project is within the subgroup of NASH patients with liver fibrosis, meaning at a later stage of disease progression. This makes NV556 best suited as a complement to NASH therapy focused on the early metabolic stage of the disease. Furthermore, it provides an opportunity to develop projects targeting other types of fibrotic disease. The goal is to reach an agreement with a suitable partner for this niched NASH product.
1) Global Data, OpportunityAnalyzer: NASH – Opportunity Analysis and Forecasts to 2026