Emmaus Life Sciences Reports Additional Positive Preliminary Results in Diverticulosis Pilot Trial
--Interim Analysis Indicates Decreased Number of Diverticula and Healthy Tissue--
TORRANCE, Calif., Aug. 05, 2020 (GLOBE NEWSWIRE) -- Emmaus Life Sciences, Inc. (OTCPK: EMMA), a leader in sickle cell disease treatment, announced today preliminary top-line data for two patients who most recently completed the first six months of the scheduled twelve months of treatment in a pilot study of diverticulosis. The study is utilizing the same pharmaceutical-grade L-glutamine (PGLG) oral powder used in Endari® to evaluate the change in the number and size of colonic diverticula and assess safety.
The following table summarizes the data:
Number of diverticula in the sigmoid colon following six months treatment on PGLG
As the sigmoid colon is the most frequent site for diverticulitis,Emmaus’ observations are focused on sigmoid diverticula. In addition to the significant reduction in the number of diverticula, in each of these patients, the investigator noted the appearance of healthier mucosa with pinkish coloration compared to the baseline. There were no safety concerns reported by the patients.
Dr. Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer of Emmaus commented, “We are pleased to provide this remarkable topline data where we observed consistent improvement in the study patients. L-glutamine is known to support mucosa of the intestine and to strengthen musculature. While the pilot study is still ongoing, Emmaus will be preparing for a Phase 3 trial to assess the efficacy and safety of PGLG in the treatment of diverticulosis.”
Emmaus has issued patents in the U.S., Europe, Japan, Australia, India, Mexico, China, Indonesia, South Korea and Russia related to compositions, including PGLG, and methods of administration of PGLG for the treatment of diverticulosis.
Diverticulosis, or the presence of colonic diverticula (i.e., pouches in the colon wall), is very common in industrialized nations. The prevalence of this condition increases with age. An estimated 40% of 60 year-olds and 70% of 80 year-olds in the U.S. have diverticulosis. Of these patients, 10% to 25% can be expected to develop diverticulitis, the advancement of peridiverticular inflammation and infection, resulting in abdominal pain, nausea, vomiting, constipation, diarrhea, fever and leukocytosis (i.e., abnormally high white blood cell count). Diverticulosis is an often asymptomatic gastrointestinal (GI) condition that can sometimes progress to diverticulitis, a debilitating GI disease that often requires hospitalization and on occasion surgical intervention.
About Emmaus Life Sciences
About Endari® (L-glutamine oral powder)
Important Safety Information
Adverse reactions leading to treatment discontinuation included one case each of hypersplenism, abdominal pain, dyspepsia, burning sensation, and hot flash.
The safety and efficacy of Endari in pediatric patients with sickle cell disease younger than five years of age has not been established.
For more information, please see full Prescribing Information of Endari at: www.ENDARIrx.com/PI.
About Sickle Cell Disease