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news.Genervon Biopharmaceuticals has reported results from its two Phase IIa double blinded, randomized, placebo controlled clinical trials of its drug candidate GM6 in patients with Amyotrophic Lateral Sclerosis (ALS) and Parkinson’s disease (PD).
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The company said that the drug candidate in the ALS trial is called as GM604 and GM608 in the PD trial.
For the treatment of ALS, the company has received both fast track and orphan drug designations for GM 604.
Results of these trials have been submitted to the US Food and Drug Administration (FDA) for guidance on how to make GM6 available as a therapeutic ALS and PD drug.
Both the trials are designed to determine whether a six-dose treatment of GM6 would begin the process of disease modification.
The company said that both clinical and biomarker data in the ALS and the PD trials reported statistically significant results, which suggest that GM6 has a disease-modifying effect, indicating that a six-dose treatment of GM6 begins the disease modification process.