Just weeks after laying out claims on positive Phase III data for their ALS drug masitinib, French regulatory authorities are dropping the hammer on AB Science, ordering a halt to clinical research work on the drug until the biotech can prove it’s compliant with rules governing drug study conduct.
In a release out early Friday, the biotech said that the Agence Nationale de la Sécurité des Médicaments is demanding an external audit to clear their work on trial procedures. AB Science says that the ANSM zeroed in on a troubled study —AB06006 — involving masitinib in treating mastocytosis. But those problems, the biotech kicked back, all occurred between 2009 and 2015, before they put a new quality control system in place.
The biotech — a publicly traded company in France — added that the suspension of all trial work on the drug is only temporary and they plan to get it all resolved expeditiously, completing the audit “in coming months.”
In addition, AB’s lengthy statement noted that the suspension of trial work is limited to France. It won’t affect their ALS plans, they add, because their late-stage trial occurred outside of France and the audit will be completed soon in any case.
The 16-year-old biotech, though, run by co-founder and CEO Alain Moussy, has a credibility issue. Over the years AB Science has been known to put out cheery releases on data and prospects only to be forced to walk it all back. The EMA rejected its marketing applications on masitinib for advanced inoperable pancreatic cancer and gastrointestinal stromal tumors in 2014 and 2013, hammering the company on poor trial design, safety as well as manufacturing shortcomings.
The timing of the halt couldn’t have come at a worse moment. In March researchers claimed the first ever successful Phase III study in ALS, with plans to detail the data at an upcoming scientific conference. The drug was filed at the EMA last fall for ALS.
Just days ago Mitsubishi Tanabe won the first new drug approval at the FDA in more than 20 years, for Radicava, and only after they asked the company to file it for a marketing OK. The last new therapy, Rilutek (riluzole) from Sanofi, arrived in the US in the mid-90s, underscoring just how difficult this disease has been to tackle in the clinic.
AB Science’s trouble could work to the advantage of Cytokinetics, which is working on a late-stage ALS drug called tirasemtiv.
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