Isis hails a Phase II diabetes victory, with caveats

Isis Pharmaceuticals ($ISIS) is touting positive mid-stage results for its in-development Type 2 diabetes treatment, which significantly improved blood sugar levels and body weight. But the company didn't disclose how the drug did against the study's primary goals, clouding its promise and spurring investor doubts.

In a placebo-controlled trial on 92 diabetics, patients taking the drug, ISIS-PTP1B, posted a 0.7% reduction in average blood sugar levels at 36 weeks, handily beating out the 0.2% for those taking saline solution. But, as TheStreet's Adam Feuerstein pointed out, the drug's primary endpoint was meant to be assessed after 26 weeks, not 36. Furthermore, Isis reported that its drug charted a statistically significant reduction in body weight from baseline over the same period, making no mention of how ISIS-PTP1B fared compared to placebo, which was its prespecified secondary endpoint.

Isis didn't respond to a request for comment on the disparity on Tuesday morning, but speculation that the company is dressing up a miss for ISIS-PTP1B helped send its shares down about 5%.

On the safety side, Isis said the drug was "generally well tolerated," leaving out specifics but citing the most common side effect as "infrequent" irritations at the site of injection. The company didn't specify whether ISIS-PTP1B met its co-primary endpoint of 38-week safety.

Isis COO B. Lynne Parshall

Isis' drug is designed to help patients get their blood glucose under control by increasing the body's sensitivity to insulin. The injected treatment works by blocking the production of an enzyme called protein-tyrosine phosphatase 1B (PTP-1B), which stands in the way of the insulin signaling pathway.

The company, calling the Phase II results an unequivocal positive, is now in the process of discussing further development with potential partners, Chief Operating Officer B. Lynne Parshall said.

"ISIS-PTP1B is a drug that has the potential to address several unique segments of the Type 2 diabetes population and has the potential to both delay the need for insulin as well as to make insulin therapy more effective, thereby addressing a significant unmet medical need," Parshall said in a statement. "We and our advisors believe that ISIS-PTP1B could be developed for patients with Type 2 diabetes who are failing oral antidiabetic therapies or GLP-1 agonists, thereby delaying the need to initiate insulin therapy."

- read the results
- check out TheStreet's story

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