Albany, New York (09/24/2014) – Galmed Pharmaceuticals Ltd (NASDAQ:GLMD) has received fast track status for its product candidate, Aramchol. The designation is given by FDA to accelerate the development process. Aramchol is the drug candidate of Galmed to treat the patients suffering from Non-Alcoholic Steato-Hepatitis.
The fast track status holds a lot more significance for the pharmaceutical companies. It fastens the development and review process of treatment drugs which are meant for the treatment of life-threatening diseases. NASH is a severe chronic disease that affects about 12% of the U.S. population. The disease is expected to rise with the rising percentage of people suffering from obesity and diabetes. As of now, there are no approved drugs for the treatment of Non-Alcoholic Steato-Hepatitis.
Recently Galmed Pharmaceuticals Ltd (NASDAQ:GLMD) said that it intends to start an IIb clinical study trial of Aramchol. There will be 240 NASH patients enrolled in the trial. The patients who are obese and insulin resistant in Europe, Israel and certain Latin American countries will be a part of the trial. It will be done as per the Medicines and Healthcare Products Regulatory Agency. The study is an important one as if it is successful; it can serve as an important base for third phase pivot trails of drug Aramchol.
The management view
Allen Baharaff, the CEO of Galmed Pharmaceuticals Ltd (NASDAQ:GLMD), said that the new designation will enable the continued contact between the FDA and Galmed Pharmaceuticals to optimally plan Aramchol’s future studies. It will assist the clinical trials in the UK. It will speed up the development activities as well as can become a means for an early FDA approval. Galmed Pharmaceuticals Ltd (NASDAQ:GLMD) received the approval for investigational NDA for its drug Aramchol in July 2014. It was approved after the completion of set standards of preliminary testing and protocols as required by the FDA.