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Partnering and out-licensing

 

Partnering

 

Primary mitochondrial disorders

NeuroVive 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.

Traumatic brain injury, TBI

NeuroVive'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.

For further information contact bd@neurovive.com


 

Out-licensing

 

Non-alcoholic steatohepatitis – NASH

 

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 NeuroVive’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.

NV422 targets the metabolic components of NASH by using mild, liver-targeted protonophores to uncouple energy-linked functions and increase energy expenditure in the liver. This removes excess fat storage and thereby counteracts the pathophysiological processes in NASH. NeuroVive has evaluated various substances within the project in 2018 and has selected a candidate substance, NV422, based on favorable pharmacokinetic profile and good tolerability.

1) Global Data, OpportunityAnalyzer: NASH – Opportunity Analysis and Forecasts to 2026


 

Hepatocellular carcinoma

 

Hepatocellular Carcinoma (HCC) is the sixth most common type of cancer, with about 780,000 new cases diagnosed annually, and the third most deadly type of cancer worldwide. In Europe, HCC is the 14th most common type of cancer, with 63,500 new cases diagnosed each year. While surgery, chemotherapy and radiotherapy are important starting points for the treatment of liver tumors, there is a major medical need for more and effective complementary medical treatments to decrease side effects and increase the survival rate for people with liver cancer.1) 2) 3) 4)

NVP024 is focused on the anticancer properties of a sub-set of the company’s sanglifehrin-based compounds. Together with international partners, NeuroVive’s research team has demonstrated that these compounds show powerful anticancer effects in preclinical models of HCC. Additional confirmatory tests are ongoing, for instance within the framework of a PhD project at Lund University, funded by the Foundation for Strategic Research.

1) Altekruse SF, McGlynn KA, Reichman ME: Hepatocellular carcinoma incidence, mortality, and survival trends in the United States from 1975 to 2005. J Clin Oncol 27 (9):1485-91, 2009.
2) Forner A, Llovet JM, Bruix J: Hepatocellular carcinoma. Lancet 379 (9822): 1245-55, 2012.
3) Sandhu DS1, Tharayil VS, Lai JP, Roberts LR. Treatment options for hepatocellular carcinoma. Expert Rev Gastroenterol Hepatol. 2008 Feb;2(1):81-92. doi:10.1586/17474124.2.1.81.
4) http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/liver-cancer/incidence#heading-Nine

 


 

Licensing objectives

NeuroVive is seeking to out license these highly innovative, novel and differentiated programs in NASH and HCC to development partners with the capability to continue preclinical development and move to clinical development and commercialization. 

For further information contact bd@neurovive.com

BD Contact

Mark Farmery

Mark Farmery

VP Business Development

bd@neurovive.com