Patent protected L-glutamine therapy, in addition to the Fast Track designation from the FDA, has received orphan drug status in the US and Europe.
The double-blind, prospective, randomized, placebo-controlled, parallel-group, multi-center study has recruited patients from across 31 sites in the US.
Research on L-glutamine therapy was led by Niihara and investigators at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, claims the company.
Emmaus Medical founder and CEO Yutaka Niihara said with the completion, the company has moved one step closer to bring the widely available treatment to patients suffering from the debilitating disease of sickle cell anemia and Beta0-thalassemia.
"Without the generous support of our investors, who have contributed nearly $30 million to advance this treatment for sickle cell disease, we would not have been able to progress this far," Niihara added.
"I am grateful for their continued support and look forward to completing the trial and analyzing results from the phase 3 study."