As it gears up to start a North American Phase III study of its drug candidate for uremic pruritis, privately held Acologix Inc. brought in $25.3 million in its Series C financing round.
The Hayward, Calif.-based company, which has raised about $72 million to date, completed its $39.6 million Series B round in May 2004 to push a hard tissue regeneration compound into Phase II trials. Acologix had anticipated that money sustaining its operations for three years but that was before it in-licensed rights to a late-stage compound, AC-820, from Tokyo-based Toray Industries Inc. in June.
After that "we wished to secure additional financing," said Yoshi Kumagai, company president and CEO, "so we could have funds to sponsor a Phase III trial of AC-820 in North America."
Though financial terms of the collaboration were not disclosed, Acologix is responsible for developing and commercializing the drug in the U.S. and Canada, and it agreed to share 50 percent of the costs for the product's European development. Toray continues to develop AC-820 on its own in Japan.
AC-820, a selective kappa opioid receptor agonist, is being developed for uremic pruritis, a systemic itching condition experienced by patients on dialysis. Acologix said that as many as 50 percent of dialysis patients could suffer from the condition, with about 30 percent developing severe, long-term effects.
In early studies, AC-820 has demonstrated an ability to reduce a neurotransmitter-induced scratching behavior with fewer side effects than morphine-like compounds and other mu-opioid receptor agonists.
Phase III trials of the drug are ongoing in Europe and Japan, Kumagai said, with a Phase III trial expected to start in the U.S. next year and to conclude in 2008.
Funds from the Series C round are expected to take the company to the end of 2007, though "that depends on how quickly we get through development and how quickly we move with our other programs," he told BioWorld Today.
Some proceeds from the recent financing are expected to support development of the company's bone drug, AC-100, which is in Phase II trials in periodontal and dental indications. AC-100, also called Dentonin, is a synthetic peptide derived from an endogenous human protein produced by bone and dental cells; it is believed to be a potential adjunct to common dental procedures, such as re-growing bones to support dental implants.
In one trial, AC-100 is being delivered during periodontal surgery in combination with a collagen matrix to re-grow and regenerate bone loss due to periodontal disease. The second trial is evaluating the product in dental pulp protection.
Kumagia said those trials are expected to be completed in the spring, and Acologix likely will "find an appropriate corporate partner" for late-stage development and commercialization.
"We're also working on a different formulation" for AC-100, he said, which would aim at treating bone fractures. If successful, "you'd be able to inject this formulation to accelerate the healing of bone."
Acologix's pipeline also includes a preclinical compound, AC-200 (Phosphatonin), for the treatment of hyperphosphatemia and other clinical problems associated with chronic kidney disease. AC-200 is an endogenous polypeptide hormone designed to regulate serum phosphate levels.
Previous investors Tokio Marine & Nichido Fire Insurance Co. Ltd. and Nomura Research and Advisory Co. Ltd., both of Japan, along with Palo Alto, Calif.-based JAIC America, participated in the Series C round. New investors were Nomura Securities Co. Ltd. and Singapore-based UOB JAIC Venture Bio Investments Ltd.