Less than a week after filing for an initial public offering in which it hopes to raise $86.25 million - and earlier than the company planned - Peninsula Pharmaceuticals Inc. started a Phase III trial of its lead antibiotic, doripenem.
The company is in a quiet period related to the IPO as required by the SEC, but said in a press release that the multicenter, double-blind, randomized trial will enroll about 450 patients and evaluate intravenous doripenem in pyelonephritis, or complicated lower urinary tract infections.
Participants will be recruited at more than 50 sites in the U.S., Europe and South America. The primary endpoint of the trial is microbiological response in patients who can be evaluated at the test-of-cure visit, which takes place five to nine days after therapy is completed.
The Phase III trial is slightly ahead of schedule. In the prospectus for its IPO, the company stated Phase III trials with doripenem in three separate indications were expected to start in the first half of next year.
Doripenem, which works by disrupting cell-wall synthesis, is a new member of the carbapenem class of antibacterials. Discovered by Shionogi & Co. Ltd., the compound has proven active in vitro against Gram-positive and Gram-negative bacteria, including penicillin-resistant Streptococcus pneumoniae.
Peninsula, of Alameda, Calif., in-licensed the drug earlier this year from Osaka, Japan-based Shionogi, buying the rights to develop and sublicense it. (See BioWorld Today, May 28, 2003.)
Proceeds from the company's recently filed IPO will be used to advance doripenem and other product candidates, plus general corporate purposes and possibly for acquisitions of new products or candidates. If the offering pulls down as much cash as Peninsula hopes, the funds will last for at least the next 24 months, the company said. (See BioWorld Today, Dec. 18, 2003.)
Started in February 2002 with $500,000 in initial investment funds, Peninsula raised another $22.1 million in venture capital in October of that year, and as of Sept. 30 of this year had about $10.5 million in cash, cash equivalents and short-term investments. (See BioWorld Today, Oct. 29, 2002.)
Behind doripenem in the pipeline are doripenem for inhalation in pulmonary infections in cystic fibrosis patients, and PPI-0903 (formerly TAK-599), an intravenous broad-spectrum antibiotic for severe and difficult-to-treat infections, including resistant Gram-positive ones. Both are expected to enter clinical trials in the first half of next year.