--Interim Analysis Indicates Decreased Number of Diverticula and Healthy Tissue--
Torrance CA, August 5, 2020 - 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
|
Patient |
Baseline |
Six Months |
Percentage Reduction |
|
52 year-old female |
8 |
4 |
50% |
|
59 year-old female |
7 |
0 |
100% |
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.
About 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
Emmaus Life Sciences, Inc. is a commercial-stage biopharmaceutical company engaged in the discovery, development, marketing and sale of innovative treatments and therapies, including those in the rare and orphan disease categories. For more information, please visit www.emmauslifesciences.com.
About Endari® (L-glutamine oral powder)
Indication - Endari is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older.
Important Safety Information
The most common adverse reactions (incidence >10 percent) in clinical studies were constipation, nausea, headache, abdominal pain, cough, pain in extremities, back pain, and chest pain.
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
Sickle cell disease is an inherited blood disorder characterized by the production of an altered form of hemoglobin which polymerizes and becomes fibrous, causing red blood cells to become rigid and change form so that they appear sickle shaped instead of soft and rounded. Patients with sickle cell disease suffer from debilitating episodes of sickle cell crises, which occur when the rigid, adhesive and inflexible red blood cells occlude blood vessels. Sickle cell crises cause excruciating pain as a result of insufficient oxygen being delivered to tissue, referred to as tissue ischemia, and inflammation. These events may lead to organ damage, stroke, pulmonary complications, skin ulceration, infection and a variety of other adverse outcomes. Sickle cell disease is a significant unmet medical need, affecting approximately one hundred thousand patients in the U.S. and millions worldwide, the majority of which are of African descent. An estimated 1-in-365 African American children are born with sickle cell disease.
Forward-looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding the preliminary observations in its diverticulosis study. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including the risk that the preliminary analysis may change upon further evaluation or may not be able to be replicated in a larger patient sample and other risks and uncertainties inherent in early-stage clinical studies, risks and uncertainties related to the company’s working capital and ability to carry on its existing operations and obtain needed financing and other factors previously disclosed in the company’s reports filed with the Securities and Exchange Commission, and actual results may differ materially. Such forward-looking statements speak only as of the date they are made, and the company assumes no duty to update them except as required by law.
Company Contact: Investor Relations Contact:
Emmaus Life Sciences, Inc. LifeSci Advisors
Joseph (Jay) C. Sherwood III Bruce Mackle
Chief Financial Officer (929) 469-3859
(310) 214-0065, Ext. 3005 bmackle@lifesciadvisors.com
jsherwood@emmauslifesciences.com