Amylin Pharmaceuticals Inc. started the second of three Phase III trials on AC2993, a compound designed to treat people with Type II diabetes by improving glucose control.
AC2993 (synthetic exendin-4) is a 39-amino-acid peptide that has been shown to stimulate secretion of insulin in the presence of elevated blood glucose concentrations, except during periods of low blood glucose concentrations (hypoglycemia).
San Diego-based Amylin plans to help pay for continued development of the compound through a public offering of 10 million shares of its common stock. The offering is being made pursuant to a shelf registration statement filed in December that would allow the company to sell up to 13.3 million common shares.
On Tuesday the company filed a preliminary prospectus supplement for the offering scheduled to be managed by Goldman Sachs and Lehman Brothers, both of New York. The company also proposed to grant an overallotment option to the underwriters to purchase up to an additional 1.5 million shares.
Amylin’s stock (NASDAQ:AMLN) closed Wednesday at $8.67, up 29 cents.
According to the prospectus, the company expects the aggregate net proceeds will be $92.3 million from the offering and overallotment option, based on an assumed offering price of $8.50 per share. Eric Shearin, manager of investor relations for the company, told BioWorld Today that proceeds would pay for ongoing development of AC2993 as well as for general corporate and administrative purposes.
Amylin had $65.8 million in cash at the end of the third quarter, and would have 77.6 million shares outstanding after the common stock offering.
AC2993 is second in Amylin’s pipeline behind Symlin, an analogue of human amylin, a hormone secreted with insulin by the beta cells in the pancreas.
Analysts are projecting Symlin sales to top $260 million worldwide as an adjunctive therapy with insulin for the treatment of Type I and insulin-using Type II diabetes patients. The FDA, however, won’t clear Symlin for marketing until Amylin conducts follow-up safety and prescribing trials. (See BioWorld Today, Oct. 15, 2001.)
“We’re working on the clinical work that was agreed to with the FDA and we plan to submit an amendment on Symlin sometime in the second half of the year,” Shearin said. “The review time for an amendment is probably two to six months, so we are looking at approval sometime in the first half of next year assuming that everything goes according to the plan.”
Meanwhile, Amylin will continue advancing AC2993 through the clinic.
The second Phase III study announced Wednesday will include about 400 patients who will be randomized into three groups, two on AC2993 and one on placebo. All participants will continue to be treated with sulfonylureas during the study.
The study is part of the company’s AMIGO program (AC2993: Diabetes Management for Improving Glucose Outcomes), aimed at demonstrating AC2993’s ability to improve glucose control in people with Type II diabetes who are not achieving their target blood glucose levels with metformin and/or sulfonylureas.
The first study, which started in December, also will enroll 400 patients. It will evaluate AC2993’s ability to improve glucose control in Type II diabetes patients who are not achieving desired blood glucose levels with metformin alone. (See BioWorld Today, Dec. 11, 2001.)
Shearin said the final Phase III is expected to begin sometime this quarter. It will look at the effects of AC2993 when added to the combination of metformin and sulfonylureas.
“We imagine that we will be able to report our first results sometime in early 2003, and we are estimating the NDA [new drug application] filing would be a year after that,” Shearin said.
In other business, the long-acting-release formulation of AC2993, or AC2993 LAR, is in Phase I development, and AC3056 is in Phase I evaluation as a treatment for metabolic disorders relating to cardiovascular disease.