TORRANCE, Calif.--(BUSINESS WIRE)--Emmaus Life Sciences, Inc. (Emmaus) is a proud sponsor of the upcoming 12th Annual Sickle Cell Disease and Thalassaemia (ASCAT) Conference to be held in London on October 22-24. A poster highlighting aspects of Emmaus’ phase 3 study of Endari™ will also be presented at the conference.
Emmaus’ recently approved treatment for sickle cell disease in the United States, Endari, will be featured in a poster session highlighting the results of a phase 3 trial that showed statistically significant improvements on a number of clinical outcomes among patients on Endari as compared to placebo. In particular, the abstract to be presented at ASCAT supports those findings indicating that improvements occurred in patients that used Endari alone or in combination with hydroxyurea.
More specifically, the strength and clarity of the claims that Emmaus’ phase 3 trial was able to make regarding the improved outcomes in both the Endari-alone patients, and the Endari-plus-hydroxyurea patients, may have been undermined by the lack of compliance among those patients that were on hydroxyurea. It is well understood that in practice, hydroxyurea patients are not very compliant. The University of Illinois research team analyzed mean corpuscular volume (MCV) data from the Emmaus phase 3 study and determined that patients on hydroxyurea therapy were indeed compliant with their therapy during the trial period. This was true for patients assigned to Endari and those that were assigned to placebo. Therefore, the beneficial effects of Endari among patients on it alone and in those taking hydroxyurea concomitantly, were robust and not confounded by unequal hydroxyurea compliance between study assignments.
Dr. Yutaka Niihara, CEO of Emmaus, and discoverer of this disease-modifying treatment stated, “We are pleased that the Illinois group was able to add further support to the findings of our phase 3 trial. Also, we are delighted to sponsor this important conference, one that provides an opportunity for physicians, nurses, scientists and other care-givers to learn about the latest advances in diagnoses, treatments and new developments in haemoglobinopathies. Moreover, we look forward to exposing evermore patients to our Endari product – a new therapy that has already improved the lives of so many suffering from this disease in the United States.”
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 a variety of other adverse outcomes such as acute chest syndrome that requires hospitalization. Sickle cell disease is an orphan disease, affecting approximately 100,000 patients in the U.S. and millions worldwide with significant unmet medical needs.
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Endari is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 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 Emmaus Life Sciences, Inc.
Emmaus Life Sciences, Inc. is a biopharmaceutical company engaged in the discovery, development and commercialization of innovative treatments and therapies primarily for rare and orphan disease. Its lead product, Endari, demonstrated positive clinical results in the completed Phase 3 clinical trial for sickle cell anemia and sickle ß0-thalassemia and has received U.S. FDA approval. Visit: http://www.emmausmedical.com.
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and potential commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. Additional risks and uncertainties are described in reports filed by Emmaus Life Sciences, Inc. with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Emmaus is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.