NeuroVive reports positive pre-clinical results in NASH

Lund, Sweden, November 1, 2016 - NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP, OTCQX: NEVPF), the mitochondrial medicine company, today announced positive pre-clinical results with one of its cyclophilin inhibitors, NVP018, in an experimental model of the chronic and common liver condition NASH (non-alcoholic steatohepatitis). The NASH project is in line with the company’s updated business strategy which includes increased and accelerated efforts in moving high potential discovery projects forward with the aim of out-licensing them in the preclinical phase.

The present data shows that NVP018 prevents fibrosis development in a well-validated experimental model of NASH. Further experimental activities with NVP018 within NASH are ongoing.

In addition, NeuroVive is developing a new class of compounds with a different mode of action that may offer complementary treatment of NASH. This discovery project is based on NeuroVive’s core competence in mitochondrial energy regulation and the partner company Isomerase’s innovative chemistry capabilities.

“The current experimental result in NASH is an excellent example of the strength of the research within NeuroVive and the successful collaboration with Isomerase. The result at hand is an important step forward in our continued development for out-licensing in this therapeutic area”, said Erik Kinnman, CEO NeuroVive. “Given the huge patient population and the high unmet medical need, we see our results and activities in NASH as high potential near term value drivers and potential revenue sources in NeuroVive’s pipeline.”

The company has implemented a business model going forward that contains two parts. One part involves high potential large indication projects like NASH, for out-licensing in the preclinical phase. The second part is to take drugs for rare diseases with high unmet medical need through clinical development and into the market. NeuroVive’s core research and development area continues to be mitochondrial medicine, with the aim to offer new treatment options to patients with unmet medical needs. There is a continuous growing understanding for the importance of mitochondrial function in many diseases.

About NASH
NASH – non-alcoholic steatohepatitis – is a progressive disease that can lead to liver cirrhosis and the development of hepatocellular carcinoma. NASH liver damage is caused by a buildup of fat and inflammatory changes in the liver. It is part of a group of conditions called nonalcoholic fatty liver disease (NAFLD) that is one of the most common conditions worldwide. It is estimated that 20 % of the global population suffers from NAFLD and about one-third of the population in the US. There is a strong association between NASH and a variety of metabolic syndromes like diabetes and obesity. Approximately 3-5 % of Americans (approx. 15 million people) suffer from NASH and there are currently no registered drugs for the treatment of this condition.1)

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

About NVP018
NVP018 is a potent non-immunosuppressive cyclophilin inhibitor within NeuroVive’s new compound class Sangamides. In this cyclophilin inhibitor chemical family, NVP018 is the oral version of its lead compound (NV556) which has undergone extensive preclinical development.

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 take 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 with capacities within 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 neurological and metabolic diseases such as NASH.

NeuroVive is listed on Nasdaq Stockholm, Sweden (ticker: NVP). The share is also traded on the OTCQX Best Market in the US (OTC: NEVPF).

For investor relations and media questions, please contact:
Cecilia Hofvander, NeuroVive, Tel: +46 (0)46 275 62 21 or ir@neurovive.com
Charles Athle Nelson, NeuroVive US representative, Tel +1 212 961 6277 or ir.usa@neurovive.com

NeuroVive Pharmaceutical AB (publ)
Medicon Village, SE-223 81 Lund, Sweden
Tel: +46 (0)46 275 62 20 (switchboard), Fax: +46 (0)46 888 83 48
www.neurovive.com

This information is information that NeuroVive Pharmaceutical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:30 a.m. CET on November 1, 2016.

About Us

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 take 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 with capacities within 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 neurological and metabolic diseases such as NASH. NeuroVive is listed on Nasdaq Stockholm, Sweden (ticker: NVP). The share is also traded on the OTCQX Best Market in the US (OTC: NEVPF). www.neurovive.com

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Quotes

The current experimental result in NASH is an excellent example of the strength of the research within NeuroVive and the successful collaboration with Isomerase. The result at hand is an important step forward in our continued development for out-licensing in this therapeutic area
Erik Kinnman, CEO
Given the huge patient population and the high unmet medical need, we see our results and activities in NASH as high potential near term value drivers and potential revenue sources in NeuroVive’s pipeline
Erik Kinnman, CEO