Dublin-based Alkermes plc announced positive results from an early-stage stage study, evaluating its novel monomethyl fumarate (MMF) molecule in development for the treatment of multiple sclerosis (MS).
The company announced positive topline results from a Phase I study of ALKS 8700, the company’s reformulated version of Biogen Idec’s blockbuster MS pill Tecfidera. The study evaluated the safety, tolerability and single-dose pharmacokinetics of several oral formulations of ALKS 8700 compared to both placebo and active control groups in 104 healthy volunteers.
According to study data, ALKS 8700 was generally well tolerated and provided MMF exposures comparable to Tecfidera, with less variability and improved gastrointestinal (GI) tolerability. In the study, only 8.3 percent of those taking ALKS 8700 reported GI side effects versus 41.7 percent in those taking Tecfidera. Based on the positive results from the study, the company is requesting a meeting with the US Food and Drug Administration (FDA), and plans to advance the drug with twice-daily dosing into pivotal development in 2015.
“The results from this study demonstrated ALKS 8700 converts efficiently into MMF after oral administration with the potential to offer improved GI tolerability for patients with MS,” said Elliot Ehrich, MD, Chief Medical Officer of Alkermes. “This highly informative clinical study provided clear data regarding dose selection and supports our decision to advance ALKS 8700 twice-daily into pivotal development later this year. In addition, it provided new insights into approaches for once-daily dosing options, which we will continue to pursue.”
ALKS 8700 is an oral, novel MMF molecule in development for the treatment of MS. It is designed to rapidly and efficiently convert to MMF in the body and to offer differentiated features as compared to the currently marketed dimethyl fumarate, Tecfidera. Tecfidera was approved in March 2013, and has generated $2.9 billion during the 2014 fiscal year.
MS is a disabling disease of the central nervous system (CNS), which interrupts the flow of information within the brain and between the brain and body. Symptoms of the disease, which can vary over time and from person to person, may include extreme fatigue, impaired vision, problems with balance and walking, numbness or pain and other sensory challenges, bladder and bowel symptoms, tremors, problems with memory and concentration, mood changes, and more. There are approximately 400,000 individuals in the US and 2.5 million people worldwide with MS.
Source: Alkermes plc