Earlier this month, Newron Pharmaceuticals announced that it would soon execute a Phase 2 clinical trial of its VEGF treatment known as sNN0029. The announcement comes shortly after one of the lead investigators, Philip Van Damme, PhD, reported the results of the Phase 1 clinical trial during the International ALS/MND Research Symposium in Brussels held in December 2014. The Phase 2 clinical trial announced by Newron is not open for enrollment at the time of publication of this statement. As soon as it is, we will update our clinical trial database which provides email updates upon subscription.
VEGF is thought to play a role in the health of motor neurons, and the company NeuroNova began a clinical trial of their VEGF compound sNN0029 to in 2008. Newron Pharmaceuticals acquired NeuroNova in December 2012.
Earlier preclinical studies conducted in SOD1 rats with the compound, and others in SOD1 mice, where both quite small but produced modest improvements in survival overall. These results provided the company enoughinformation to launch their clinical research efforts.
The Phase 1 clinical trial of sNN0029 included three different doses of the compound, as well a placebo arm. This multi-arm clinical trial is now completed. In total there were 19 PALS enrolled in the study, which included two different cohorts, one placebo control (N=10) and the other not (N=8). In the placebo controlled cohort, four PALS received the high dose (2ug/day) and three received a lower dose (0.8 ug/day) and were compared to three additional PALS given a placebo. The other cohort looked at a lower dose as well (0.2 ug/day) in 2 PALS, 2 at the middle dose and 4 at the high dose. During his presentation in December, Van Damme was clear to the audience that the study was in no way powered to measure efficacy, but that the data suggested clearly that sNN0029 was safe and tolerated in all PALS in the trial.
It is interesting to note that 66% of the trial’s participants were male, and on average the onset age of enrolled PALS was 48 years old. During the post-presentation discussion, audience members asked Van Damme if he thought that a higher dose of VEGF would be tolerable, which he responded he thought perhaps but that any follow up trial would likely use the doses informed on in the early trial. The announcement from Newron recently reports that PALS enrolled in the Phase 2 clinical trial may receive does up to two times greater than those given in the earlier trial.
For More Information:
· About sNN0029
· Newron Press Release
· Recap of Van Damme’s Presentation on sNN0029 during 2014 International ALS/MND Research Symposium