NeuroNova submits a clinical trial application to initiate the first-in-human study with sNN0029 for patients with Amyotrophic Lateral Sclerosis.

NeuroNova AB, a privately held Swedish biopharmaceutical company pioneering therapeutic neurogenesis for disorders of the central nervous system, has submitted a clinical trial application to the Federal Agency for Medicines and Health Products in Belgium to initiate a first-in-human study with the drug product sNN0029 in patients with Amyotrophic Lateral Sclerosis (ALS).

ALS is one of the most devastating diseases of the central nervous system and characterized by progressive muscle weakness that may affect the limbs as well as muscles involved in speech and swallowing. The mean survival from diagnosis is 30 months with wide variation. The need for an effective treatment is very high.

sNN0029 contains very low doses of the naturally occurring protein VEGF (Vascular Endothelial Growth Factor) which has been shown to cause improved muscle strength and prolonged survival in an animal model of ALS, using direct administration of VEGF into one of the fluid filled cavities of the brain. Disturbances in the ability to produce VEGF have been demonstrated in patients with ALS which further supports the hypothesis that sNN0029 administration may slow disease progression.

The first-in-human study is intended to investigate the safety and tolerability of intracerebroventricular administration of sNN0029 to patients with ALS using an implanted catheter and pump. Treatment will be given for 12 weeks and is planned to be followed by a continued treatment to evaluate the long-term safety. If the treatment is demonstrated to be safe and well tolerated, subsequent studies will focus on therapeutic efficacy. "We are excited to approach the clinical testing of our drug product that may offer improvement in muscle function and prolonged survival to patients with this disease", says Markus Jerling, CMO.

For more information on this project, please contact:

Markus Jerling, CMO, NeuroNova AB Tel: +46 (0) 8 786 0900 Email: markus.jerling@neuronova.comThis e-mail address is being protected from spam bots, you need JavaScript enabled to view it

For more information on NeuroNova, please contact:

Ulf Ljungberg, President and CEO, NeuroNova AB Tel: +46 (0) 8 786 0900 Email: ulf.ljungberg@neuronova.com