By Matthew Willett
Insmed Inc.'s analysis of Type II diabetes therapeutic INS-1 trial data confirmed the candidate's Phase I results and gained back a chunk of the company's stock price after preliminary intent-to-treat figures in November showed no statistical significance compared to placebo.
Insmed's stock (NASDAQ:INSM) fell 42 percent on Nov. 27 on the preliminary analysis of the Phase II trial data, dropping the price $2.187 to $3. (See BioWorld Today, Nov. 28, 2000.)
On Friday the stock rose 44 percent, or $1.875, closing at $6.125. That's a far cry from the company's 52-week high of $49 per share, but ahead of the $5.187 close before Insmed announced the intent-to-treat analysis data.
The 246-patient Phase II trial was the first to evaluate INS-1, an oral insulin sensitizer, in combination with sulfonylurea, the standard-of-care first-line treatment.
Insmed spokeswoman Sophia Twaddell said the deeper look confirmed what the Richmond, Va., company expected in November - that a full analysis of the data excluding nonparticipatory or untreated patients would show statistically significant improvements in Type II diabetes patients treated with INS-1.
"When we do the full analysis we throw out patients who didn't comply with the terms of the protocol, and even in doing that the evaluable patient population came out to be 216 patients," Twaddell told BioWorld Today.
Full-analysis results showed combination-therapy patients experienced a statistically significant improvement in glycohemoglobin of 0.36 percent compared to patients receiving sulfonylurea alone (p<0.05).
Patient improvement in less-severe cases was even better than expected, Twaddell said.
"In fact," she said, "when we looked at the patients and stratified them by disease - one common way of cutting the data, looking at the severity of the disease - we can tell improvement by comparing what their glycolated hemoglobin was at the beginning of the trial, and by what their fasting glycose looked like at the beginning of the trial. What we found, somewhat surprisingly, was a more pronounced reaction, 0.80 percent, in patients better controlled by sulfonylurea."
The findings led Insmed to conclude that INS-1 could be more effective in patients with less-severe Type II diabetes. It also hammered home the need for a dose-regulating trial to determine optimum dosing.
"What it suggests is that INS-1 has more effect in people with less-severe diabetes," Twaddell said. "The other possibility is what we said in November, that it might be a dose-related thing. The 1,200 mg dose seemed to be creating a response early on, but we will include dose ranging as one of the variables in future studies."
Those future studies will begin enrollment soon, Twaddell said, though a change in the protocol to include a dose-ranging variable could delay the start a few weeks.
A Phase II trial examining INS-1 in conjunction with diet and exercise compared to placebo also is scheduled. The six-month trial will include a dose-ranging variable as well.
Further trials in other indications are under way. One in polycystic ovary syndrome should produce data in two or three weeks, she said, and another in dyslipidemia is ongoing.
Twaddell said the share price jump on the news is a sort of validation of the program's status.
"We're, of course, gratified to see the stock returning to a more appropriate level for the value of the company and the value of the products we have in our pipeline," she said. "I think we have two very novel products in INS-1 and SomatoKine, and we're going to have to keep going through the process into what we hope will be fully approvable drugs in the next three or four years."