Just over two months after kicking off a Phase III trial with its Alzheimer's disease drug Phenserine, Axonyx Inc. said it has entered into definitive agreements to raise $25 million in a private placement.
"This will allow us to initiate a second pivotal trial," said Gosse Bruinsma, chief operating officer of New York-based Axonyx.
In the first trial, "patients are being recruited on target, and generally these types of trials take two years," he told BioWorld Today.
New and existing investors are taking part in the stock sale, which involves about 7.47 million shares at $3.25 each. The investor group also gets five-year warrants to buy another 5.6 million shares at $3.50 each.
Phenserine, an acetylcholinesterase and beta-amyloid peptide inhibitor, is being investigated as a treatment that, unlike existing therapies, may slow progression of the disease while offering fewer side effects such as gastrointestinal trouble. (See BioWorld Today, June 27, 2003.)
"It certainly has a better chance of being approved, simply because it's a well-known drug class," Bruinsma said. But the dual mechanism of action could mean even better things - and the side-effect profile is important, he said.
"With this class of patients, dependent as they are on family and caregivers, side effects are really the last thing you want to have to deal with," he noted.
In the Phase III trial, 375 mild to moderate AD patients are being given two different doses for six months, and evaluated with standard memory and cognition tests. Axonyx also is doing a Phase IIb study measuring the drug's ability to lower the beta-amyloid precursor protein and beta-amyloid in the plasma and cerebrospinal fluid of people with mild to moderate AD.
The 75 patients in the Phase IIb study eventually will become part of the total in the Phase III trial, which is starting out with 300.
Bruinsma said the exact starting date of the second Phase III trial is unclear.
"We're in the planning stages," he said. "Speaking generically, start-up times for these Phase III trials take four to five months." He said the second Phase III may be conducted partly or wholly in the U.S., although recruiting treatment-na ve patients "could be a little difficult" in the U.S. because several treatments are approved.
Already on the market are Aricept (donepezil hydrochloride), approved in 1996 and developed by New York-based Pfizer Inc. and Eisai America Inc., part of Tokyo-based Eisai Co. Ltd.; Reminyl (galantamine HBr), from Janssen Pharmaceuticals NV, of Beerse, Belgium, approved by the FDA in 2001; and Exelon (rivastigmine tartrate), from Novartis Pharmaceuticals Corp., of East Hanover, N.J., approved in 2000.
Rodman & Renshaw Inc. and Punk Ziegel & Co., both of New York, served as placement agents for the financing, with the latter also acting as financial adviser to Axonyx.
Axonyx's stock (NASDAQ:AXYX) closed Friday at $3.68, down 25 cents. It had gained 55 cents Thursday.