Mesoblast’s stem cell candidate for chronic low back pain expected to have market access challenges, says GlobalData

In the search for non-opioid options to treat pain, Mesoblast has turned to a stem cell approach, which is currently in late-stage development for chronic low back pain. However, interviewed experts say its potential for Phase III success is uncertain due to scant human evidence with this stem cell product for treating pain. Even if it reaches the market, the therapy would face various access restrictions, according to reporting from Shuan Sim, Pharma Writer for the Investigative News team at GlobalData, a leading data and analytics company.

Sim comments: “While Mesoblast’s MPC-06-ID is projected to be a multibillion-dollar asset, experts whom I spoke to do not believe the therapy would reach blockbuster status easily”.

Nektar Therapeutics recently withdrew its approval application for its opioid treatment, NKTR-181 (oxycodegol), after receiving a 27-0 vote from the US Food and Drug Administration’s (FDA’s) Advisory Committee (AdCom) against giving the drug a go-ahead. The company’s share price dropped 15.9% the next day, 15 January. There are still 31 companies with opioid candidates in clinical development to treat pain, according to GlobalData.

There are 194 companies with 218 non-opioid drug candidates in clinical development for treating pain but only one other than Mesoblast is developing a stem cell therapy, according to GlobalData. While Mesoblast is more advanced, with Phase III results expected in 3Q20, BioRestorative Therapies has a Phase II-ready candidate, BRTX-100, for lower back pain.

Sim concluded: “While physicians are looking forward to non-opioid options, experts noted that payers would likely put up restrictions because of the expected high cost and inadequate diagnostic frameworks needed to find those patients ideally suited to receive stem cell treatment”.

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