Emmaus Life Sciences Inc (OTCQX:EMMA) has announced real-world data on the company's prescription-grade L-glutamine oral powder, Endari, in preventing acute complications from sickle cell disease and hemolysis in pediatric and adult patients in French Guiana and Qatar.
The data was introduced by the study’s chief investigator Dr Mohamed Yassin and his co-authors at the 62nd Annual Meeting of the British Society for Haematology, held earlier in April.
Data showed that statistically, sickle cell patients treated with Endari had significantly fewer vaso-occlusive events and hospitalizations through 72 weeks’ follow-up versus baseline.
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What’s more, adverse events among these patients from French Guiana and Qatar were “few and mild,” according to Emmaus.
The observed clinical benefits of Endari coincided with a significant improvement in hemolysis parameters which were sustained over the entire study period of 18 months, Yassin told investors. In addition, among the 19 study patients, the incidence of acute chest syndrome decreased from 11 events reported the year before initiating treatment with Endari, to only two events after 12 months of treatment.
“Given the deadly implications of acute chest syndrome, this real-world evidence supports the benefits of Endari for sickle cell patients,'' Yassin said.
"The clinical observations by a leading hematology center in Qatar, in cooperation with French Guiana sickle cell referral centers, demonstrated significant improvements in patient outcomes for the first time in these populations,” Emmaus CEO Yutaka Niihara said in a statement.
Niihara added that the observations are consistent with clinical data on the effectiveness of Endari in its FDA-approved indication for reducing acute complications of sickle cell disease in adults and children five years and older.
Torrance, California-based Emmaus is a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease.
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