NeuroVive Presents Preclinical Findings of NV556 in NASH Showing Confirmatory Anti-fibrotic Effects

LUND, Sweden I April 20, 2017 I NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP, OTCQX: NEVPF) ("NeuroVive") today announced positive preclinical results demonstrating anti-fibrotic effects with NV556, the company's preclinical compound for non-alcoholic steatohepatitis (NASH), in an additional well-validated experimental NASH model.

NV556 has previously shown similar anti-fibrotic effects in the experimental STAM™ NASH model. Today, NeuroVive's scientists present novel data demonstrating anti-fibrotic effects of NV5556 also in the experimental MCD NASH model, strengthening and confirming the previous findings. In addition, in the STAM model where NASH is followed by liver cancer development, long term treatment with NV556 was well tolerated and significantly reduced liver weight increase, indicating a reduced tumor burden. Furthermore, there was a trend that NV556 reduced both the number and the size of tumors on the liver surface.

"We are encouraged by the confirmation of an anti-fibrotic effect of NV556 in a second well validated experimental model. Also, the preventive effect on liver cancer development is a highly appealing observation that adds to the attractiveness of NV556 as a possible treatment candidate for patients with progressing NASH for which there is a high unmet medical need", says Magnus Hansson, M.D., Ph.D., Chief Medical Officer at NeuroVive.

Dr. Hansson and colleagues will present the poster titled "Anti-fibrotic effect of NV556, a sanglifehrin-based cyclophilin inhibitor, in a preclinical model of non-alcoholic steatohepatitis1" at The International Liver Congress™ taking place in Amsterdam, the Netherlands, 19-23 April 2017.

The International Liver Congress™ is the main annual scientific conference of the European Association for the Study of the Liver (EASL), with about 11,000 attendees, including scientific and medical experts from around the world, meeting to share and discuss the latest liver research findings.

About NV556

NV556 is a potent cyclophilin inhibitor in NeuroVive's Sangamide class of compounds. NV556 is undergoing preclinical development and has so far showed an excellent safety profile. The first preclinical results for the effects of NV556 on fibrosis development in an experimental model of NASH were received during the autumn of 2016.

In addition to NV556, NeuroVive is developing a new class of compounds with a different mode of action. This project is complementary to NV556 and may offer an alternative treatment opportunity of NASH patients. This discovery project, titled NVP022, utilizes NeuroVive's core competence in mitochondrial energy regulation, and NeuroVive's partner company Isomerase's innovative chemistry capabilities are providing chemical compounds currently undergoing experimental concept testing.

About NASH

Inflammation and excess fat in the liver are symptoms of non-alcoholic steatohepatitis (NASH), a condition that causes scarring of the liver which can lead to cirrhosis of the liver and liver cancer (hepatocellular carcinoma). There is a strong link between NASH and other metabolic disorders, such as diabetes and obesity. The disease is common all over the world, and about 3-5% of all Americans (roughly 15 million people) suffer from NASH,2 for which there are currently no registered treatment options available.

1) Grönberg Alvar, Elmér Eskil, Gregory Matthew, Moss Steven, Hansson Magnus (accepted abstract)

2) Vernon G. et al. Aliment Pharmacol Ther. 2011;34(3):274-85

About NeuroVive

NeuroVive Pharmaceutical AB is a leader in mitochondrial medicine. The company is committed to the discovery and development of medicines that preserve mitochondrial integrity and function in areas of unmet medical need. The company's strategy is to advance drugs for rare diseases through clinical development and into the market. The strategy for projects within larger indications outside the core focus area is out-licensing in the preclinical phase. NeuroVive enhances the value of its projects in an organization that includes strong international partnerships and a network of mitochondrial research institutions, as well as expertise in drug development and production.

NeuroVive has a project in early clinical phase II development for the prevention of moderate to severe traumatic brain injury (NeuroSTAT®). NeuroSTAT has orphan drug designation in Europe and in the US. The R&D portfolio consists of several late stage research programs in areas ranging from genetic mitochondrial disorders to cancer and metabolic diseases such as NASH.

SOURCE: NeuroVive

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