The development program that Vinnova is supporting involves formal preclinical development, including toxicology studies and process development for large-scale manufacture of NV354. The funding received by NeuroVive is from Vinnova’s Swelife call for applications for Projects for better health, Step 2 (2018) [SV:Projekt för bättre hälsa – Steg 2 (2018)], which is a continuation of the Step 1 funding of SEK 1 million that the company received in 2017. The Step 1 funding, facilitated the selection of the candidate compound NV354 as part of the NVP015 spearhead project, with the aim of developing a new pharmacological therapy for patients with mitochondrial disorders caused by complex I dysfunctions such as Leigh syndrome, a disorder with a significant unmet medical need.
“The goal of the NV354 development program is to markedly improve life for those patients, normally children, suffering from these types of mitochondrial disorders. This funding is of the greatest importance for effectively advancing the project and represents a mark of quality for our program,” says Eskil Elmér, Chief Scientific Officer and Vice President Discovery of NeuroVive.
“We are naturally incredibly pleased to receive this funding from Vinnova. It underscores the potential that NV354 has to make a difference for mitochondrial disorders, which has also been affirmed by the fact that our partner in the US, the Children’s Hospital of Philadelphia, received a three-year research grant of USD 4 million earlier this year for research supporting the program, and by our out-licensing of other compounds from the NVP015 project, focusing on the eye disorder LHON, to the US company BridgeBio,” said Erik Kinnman, CEO of NeuroVive.
Earlier this year, NeuroVive reported the first preclinical efficacy outcomes for NV354, and in addition has seen further convincing efficacy data in several different established experimental models of mitochondrial disorders. Apart from NeuroVive’s own research, independent studies are underway among the company’s renowned academic partners in mitochondrial medicinal research, such as the Children’s Hospital of Philadelphia, in order to obtain additional valuable data prior to the clinical development of NV354.
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 below, at 12 a.m. CET on 15 November 2018.
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AboutSwelife – for a competitive Life Science system in Sweden
Swelife is a strategic innovation program, funded by the Swedish Government via the Swedish innovation agency, Vinnova, and by the program’s partners. Swelife supports collaboration within academia, industry and healthcare, with the goal to strengthen Life Science in Sweden and to improve public health.
About genetic mitochondrial diseases
Genetic mitochondrial diseases are metabolic diseases that affect the ability of cells to convert energy. The disorders can manifest differently depending on the organs affected by the genetic defects and are viewed as syndromes. An estimated 12 in every 100,000 people suffer from a mitochondrial disease. Mitochondrial diseases often present in early childhood and lead to severe symptoms, such as mental retardation, heart failure and rhythm disturbances, dementia, movement disorders, stroke-like episodes, deafness, blindness, limited mobility of the eyes, vomiting and seizures.
One of the most common causes of mitochondrial diseases relates to Complex I dysfunction, i.e. when energy conversion in the first of the five protein complexes in the mitochondrion that are essential for effective energy conversion does not function normally. This is apparent in disorders including Leigh syndrome and MELAS, both of which are very serious diseases with symptoms such as muscle weakness, epileptic fits and other severe neurological manifestations. The NVP015 project is based on a NeuroVive innovation in which the body’s own energy substrate, succinate, is made available in the cell via a prodrug technology. A prodrug is an inactive drug that is activated first when it enters the body by the transformation of its chemical structure. Within the project a lead compound, NV354, has been selected for further development in the program based on efficacy, tolerability, oral bioavailability, plasma stability and organ delivery, specifically to the brain. In 2017 NeuroVive received a research grant from the Swedish innovation agency, Vinnova, for developing the succinate prodrugs as a new treatment for genetic mitochondrial diseases.
NeuroVive Pharmaceutical AB is a leader in mitochondrial medicine, with one project in clinical phase II development for the prevention of moderate to severe traumatic brain injury (NeuroSTAT®) and one project in clinical phase I (KL1333) for genetic mitochondrial diseases. The R&D portfolio also consists of projects for genetic mitochondrial disorders, cancer and NASH. The company advances drugs for rare diseases through clinical development into the market. For projects for common indications the goal is out-licensing in the preclinical phase. A subset of compounds under NeuroVive’s NVP015 program has been licenced to Fortify Therapeutics, a BridgeBio company, for local treatment development of Leber’s Hereditary Optic Neuropathy (LHON). NeuroVive is listed on Nasdaq Stockholm, Sweden (ticker: NVP). The share is also traded on the OTCQX Best Market in the US (OTC: NEVPF).