The good news seems to be coming in waves for Inspire Pharmaceuticals.

Inspire (Nasdaq: ISPH) announced Wednesday morning positive results from a Phase II clinical trial for INS37217 Intranasal in patients with the common cold.

As a result, shares of ISPH jumped more than five percent to around $6 in mid-afternoon trading.

Last week the company’s stock, which had been trading under $5 since February, soared more than 50 percent after Inspire moved a step closer to bringing its dry-eye drug to market by filing a new drug application with the FDA.

Inspire says results from its latest study were positive, demonstrating “statistically significant” improvement compared to placebo in post-nasal drip and malaise at multiple doses and on multiple days over the 14-day study period. It says INS37217 Intranasal was well tolerated in patients, with no serious drug-related adverse events reported.

The multi-center Phase II study of INS37217 Intranasal in patients with common cold was a placebo-controlled, dose-ranging trial conducted in 101 patients. Patients were dosed for six days and symptom scores were recorded for a total of 14 days.

Importantly, these results are consistent with the results seen with INS37217 Intranasal in Phase I/II and Phase II studies of patients with perennial allergic rhinitis (PAR). Last month, the company also reported encouraging results of a Phase I/II clinical trial for its drug INS37217 Ophthalmic, which is for use in patients with retinal detachment.

“This is important news for the company, because it is the third consecutive trial where we have seen positive results with this product, and gives us even greater confidence in the program as we move into Phase III in allergic rhinitis,” explains Mary Bennett, vice president of operations and communications for Durham-based Inspire.

Bennett says the fact that Inspire has seen “good effect” on the same nasal symptoms in both allergic rhinitis and common cold points to an opportunity for a number of potential indications for the product, including seasonal and PAR, common cold, sinusitis, etc.

“It appears that the product is working at reducing a wide variety of nasal symptoms,” she says. “As a result, this could be a very big market.”

The most straightforward pathway to FDA approval of the INS37217 Intranasal is pursuing the allergic rhinitis indication first. The FDA has clear guidance for clinical development of allergic rhinitis drugs, and Inspire believes these studies can be conducted relatively quickly.

“These results provide strong rationale for progressing this innovative product candidate rapidly,” Christy L. Shaffer, chief executive officer of Inspire, said in a statement. “While the priority planned indication will be for allergic rhinitis, these results support the potential use of INS37217 Intranasal for a broad range of upper respiratory disorders that are characterized by congestion, rhinorrhea, post-nasal drip, facial pain and pressure and other nasal symptoms.”

Inspire says it will launch a first Phase III trial in perennial allergic rhinitis in about 600 patients by the end of this year, and expect to have results in the second quarter of 2003.

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