AB Science has just stumbled into another setback with its all-purpose anti-inflammatory drug masitinib.
The Paris-based biotech run by founder Alain Moussy says that the CHMP has adopted a negative stance on approving the drug for ALS. And once again researchers drew some poor grades on trial design and execution.
In a release the biotech said that the CHMP noted that “the reliability of the data was not robust enough to support a registration.” They were also concerned about the possibility of bias being introduced into their analysis.
Now AB Science will do some more analysis for a re-examination and a second opinion in July.
That’s not what investors wanted to hear. The company stock (EPA: $AB) plunged 29% on the news in the latest turn of a long-running roller coaster ride.
The company has been in hot water with regulators before.
Less than a year ago French regulators ordered a trial halt on masitinib to make sure the biotech was operating in accordance with the rules on trial conduct. AB Science said at the time 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.
They shrugged off the action, saying their ALS study would be unhindered as it was being conducted outside of France.
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 big idea at AB Science is that the drug’s impact on microglia damps down inflammatory processes linked to a variety of diseases. But they’ve been having a hard time proving that.
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