February 3, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Shares of Isis Pharmaceuticals, Inc. are down Tuesday, after a well-known biotech columnist publicly disputed the company’s recent diabetes drug trial, saying it had “sweetened” the results to be more appealing to investors, and “time-shifted” its analysis.
Isis stock was down almost 6 percent in mid-morning trading Tuesday on the controversy.Adam Feuerstein, who writes a regular and closely watched column on all things biotech for The Street, took issue Tuesday with Isis’ release today that trumpeted its new drug’s efficacy. That company-vetted statement said that in a recent Phase II trial, type 2 diabetics treated with its experimental antisense drug ISIS-PTP1B Rx achieved “statistically significant reductions in hemoglobin (HbA1c) and body weight,” compared with a placebo at 36 weeks.
But that analysis didn’t provide for other time benchmarks and appears to have a few tell-tale markers of major corporate spin, wrote Feuerstein.
“OK, except the phase II study was designed to assess comparative changes in hemoglobin and body weight at 27 weeks, not 36 weeks, according to a description of the study on ClinicalTrials.gov. (Hat tip to @lomu_j for first noticing the discrepancy.)” he wrote Tuesday.
Isis also didn’t disclose how safe ISIS-PTP1B Rx was in the clinical trial, nor what its effect actually was at 27 weeks. The safety issue in particular has Wall Street watchers worried, because Isis’ only federally approved drug, Kynamro, has had significant side effects for users and has a U.S. Food and Drug Administration (FDA) “black box” safety label warning of an increased risk in liver toxicity.
“Kynamro causes injection-site reactions in 84 percent of patients and flu-like symptoms in 30 percent of patients, according to its Food and Drug Administration label,” wrote Feuerstein in pointing out safety concerns.
“As it often does when disclosing study results via press release, Isis offered few details about the safety of ISIS-PTP1B Rx other than to say that the drug was ‘generally well tolerated’ with ‘infrequent’ injection site reactions, no flu-like symptoms and no ‘clinically significant’ laboratory abnormalities,” he said.
As of press time, Isis had not issued a statement about the column.
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