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Phase III clinical trial, but Phenomix and Forest have been actively enrolling patients into three more pivotal clinical trials, Shawver says. She wouldn’t disclose how many patients those trials are supposed to enroll, but they are designed to test dutogliptin in various combinations with metformin, sulfonylurea, or metformin and Takeda Pharmaceuticals’ pioglitazone (Actos), in patients who aren’t successful at controlling their blood sugar on other meds. One of the trials is seeking to enroll 650 patients, and another is enrolling 400 patients, according to postings on clinicaltrials.gov, so the bills are obviously running into the many millions of dollars—beyond what a little biotech company like Phenomix can support on its own.
“We have to have a partner,” Shawver says. She noted that she’s looking for a new partner, and pronto.
So what did the clinical trial actually say? It enrolled 544 patients who had moderately high levels of hemoglobin A1C, a standard measure of blood sugar. They entered the study with an average score of 8.19 percent A1C (patients in the U.S. are generally considered healthy at 7 percent.)
Patients either got a once-daily 400 milligram dose of the Phenomix drug, a once-daily 200 milligram dose, or a placebo. Researchers found that at the high dose, patients had an average drop in their A1C score of 0.59 percentage points after six months of follow-up, the FDA mandated standard to show effectiveness. Those on the low dose did about half as well, seeing an A1C decline of 0.28 percentage points. Both findings were statistically significant, and the drug also reached all three of its secondary goals with statistical significance, Shawver says.
Other drugs in the DPP4 class, when tested in studies like this that are direct comparisons to placebo, have typically shown an ability to lower A1C scores between a range of 0.4 percentage points and 0.7 percentage points, Shawver says. That means the Phenomix drug “appears in-line” with its competitors, she says. It also represents an improvement from earlier results after patients were followed for three months, she says.
What about safety? The Phenomix drug was well-tolerated at both the high and low doses, according to the company statement. A little more than one-fourth of patients in both groups reported at least one adverse event while in the trial, with high blood lipids, urinary tract infections, and headache listed among the most common adverse events. The percentage of patients who dropped out of the study because of adverse events was “similar” between the Phenomix drug group and placebo, although Phenomix didn’t break out exact numbers on that question. The statement also didn’t say how many of the adverse events were mild versus those that were moderate and severe—the kind of thing that’s important to the FDA and which would surely have to be disclosed in a peer-reviewed journal.
This is obviously a delicate time for Phenomix as a company. While Forest terminated the partnership, there are ongoing Phase III trials that somebody has to be responsible for, so that’s a question that will have to be worked out soon.
Phenomix has 41 employees at the moment in San Diego, Shawver says. I asked whether she will have to resort to layoffs—which she already did about a year ago—and she noted that the company is already operating with a lean staff and needs its people to supervise the clinical trial work. Layoffs now “are not anticipated,” she says.
The bigger priority will be seeing if any other Big Pharma company will be willing to pick up where Forest is leaving off. That will be something we’ll be watching for in the weeks and months ahead.
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