Emmaus Life Sciences Reports Positive Top-Line Preliminary Results in First Patient in Diverticulosis Pilot Trial
Decreased Size of Diverticula, Indications of Healing and Normalization of Bowel Movements Observed in the Initial Patient
TORRANCE, Calif., Jan. 29, 2020 (GLOBE NEWSWIRE) -- Emmaus Life Sciences, Inc. (OTCQB: EMMA), a leader in sickle cell disease treatment, announced today the top-line preliminary results in the first patient in the company’s Pilot/Phase 1 study in the treatment 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, shape and size of colonic diverticula and assess safety. The first patient had a colonoscopy at the start of the study and another colonoscopy after six months of taking 15 grams of PGLG twice a day.
While the results in the first patient are preliminary only, the Principal Investigator (PI) observed “A marginal but decreased size in some of the diverticula compared to the baseline.” The PI also added that, “In addition, there appears to be smoothing of the edges at the opening of the diverticula compared to the baseline, suggestive of a healing process.”
Clinically, the patient reported improvement in overall condition. Prior to starting the PGLG trial, the patient experienced severe constipation alternating with diarrhea. Six months into the trial, the patient’s bowel movements are now normal and the patient reports feeling better overall.
Dr. Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer of Emmaus commented, “The initial findings are consistent with the anecdotal discovery and report which formed the basis of our hypothesis on PGLG’s efficacy for diverticulosis. We need to emphasize that this is top-line data on the first patient at an interim examination. However, we are cautiously optimistic as there has never been a treatment that has been reported to reverse diverticulosis.”
Emmaus has issued patents in the U.S., Japan, Australia, Mexico, China, Indonesia, Korea, Russia and India 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, with its prevalence increasing 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).
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.
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 the first patient 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 observations in the first patient may change upon further evaluation and may not be able to be replicated in other patients 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. firstname.lastname@example.org|
Released January 29, 2020