Novartis muscular drug fails in Phase III trials

pharmafile | April 22, 2016 | News story | Medical Communications, Research and Development FDA, Novartis, bimagrumab, breakthrough, morphosys, muscular, phase III 

A muscular drug developed by Novartis (NYSE: NVS), in partnership with MorphoSys (ETR: MOR), failed to meet its primary endpoint in a Phase IIb/III study, raising doubts over the future of BYM338 (bimagrumab) which was originally designated a “breakthrough” therapy by the US Food and Drug Administration.

Hopes were initially high for Novartis’s drug which is designed to combat the muscle loss and weakness that accompanies sporadic inclusion body myositis (sIBM). The Swiss-based company had partnered with MorphoSys’s antibody discovery platform to develop BYM338. As well as a treatment for sIBM, ongoing trials are also evaluating its efficacy in treating hip fracture recovery and sarcopenia.

The primary endpoint of the trial, along with demonstration of its safety, was the change from baseline in six minute walking distance test. This test simply measures the distance that a patient can walk in a six minute time frame. sIBM, in particular, is characterised by progressive weakness and wasting of the muscles, and it can eventually deprive patients of the ability to walk, cause them to suffer falls, lose hand function and have swallowing difficulties.

In a statement issued by MorphoSys, chief scientific officer Dr Marlies Sproll, says: “The outcome of the Phase IIb/III study with bimagrumab in sIBM is disappointing. Nevertheless, ongoing clinical trials, including those in sarcopenia and hip fracture are continuing as planned at this stage. Our collaboration with Novartis has produced eleven clinical programs to date with many more to come.”

Sean Murray

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