PALO ALTO, CA--(Marketwire - October 18, 2011) - TOPICA Pharmaceuticals, Inc., a privately held biotechnology company, today announced that it has raised $27 million in a Series B financing, led by Third Rock Ventures and existing investors Prospect Venture Partners and Yasuda Enterprise Development Corporation, Ltd. Proceeds of the financing will be used to advance the company's broad-spectrum topical antifungal agent, luliconazole, for the treatment of onychomycosis, fungal infections of the nail. Earlier this year, the company announced the successful completion of a Phase 1/2a maximal use pharmacokinetic study of its 10 percent luliconazole solution in patients with significant nail fungus.
"We are pleased that Third Rock Ventures will join Prospect Venture Partners and our Series A investors in guiding the future of TOPICA through the Series B financing period," said Greg Vontz, president and chief executive officer of TOPICA. "This Series B funding will allow TOPICA to conduct a robust Phase 2b/3 clinical trial, that if successful, will confirm luliconazole's ability to meet the U.S. Food and Drug Administration's (FDA) endpoints for approval. Luliconazole has the promise to be a more effective and safe topical therapy for the treatment of onychomycosis than existing products."
This round of funding will take the company through the completion of a Phase 2b/3 clinical trial of approximately 300 patients with mild-to-moderate distal subungual onychomycosis of the toenail. The trial will commence in the first half of 2012 and will involve approximately 20 centers in the U.S. The trial will assess the safety and efficacy of the 10 percent luliconazole solution in two dosing regimens applied for 48 weeks and will evaluate the impact of luliconazole on clear nail growth and fungal eradication at week 52. The primary endpoint of the trial will be "complete cure at week 52," which is a combined endpoint of clinical assessment of a completely clear nail and a negative fungal assessment by KOH (potassium hydroxide staining) and mycologic culture. Complete cure is the primary clinical endpoint for the conduct of pivotal clinical trials seeking FDA approval.
As part of Third Rock's investment in TOPICA, Charles Homcy, M.D., venture partner at Third Rock Ventures, will join TOPICA's board of directors. Dr. Homcy joined Third Rock Ventures in 2010 after he co-founded Portola Pharmaceuticals in 2003, where he served as the company's president and chief executive officer until 2010. Prior to that, he was president of research and development at Millennium Pharmaceuticals following the company's acquisition of COR Therapeutics in 2002. Dr. Homcy joined COR in 1995 as executive vice president of research and development where he served as a director from 1998 to 2002.
Luliconazole is one of the most potent and broad-spectrum topical antifungal agents. In numerous, rigorous preclinical models of onychomycosis, luliconazole has demonstrated rapid penetration and therapeutic levels sufficient for fungal eradication in the nail bed. This preclinical profile suggests that luliconazole has the potential to be an effective and safe topical therapy for onychomycosis. The potential annual U.S. market for onychomycosis treatment is estimated at approximately $3 billion. TOPICA has an exclusive license from Nihon Nohyaku Co., Ltd. to develop and market luliconazole for onychomycosis in the Americas and Europe.
Luliconazole in 1 percent cream and solution formulations was approved in Japan in 2005 for the treatment of tinea infections of the skin. To date, more than 8 million patients have been treated with the product in Japan, where luliconazole is one of the leading topical anti-fungal prescription products for tinea infections.
About Prospect Venture Partners
Prospect Venture Partners is a leading life sciences venture capital firm dedicated to building outstanding biopharmaceutical and medical device companies. With more than $1 billion of capital under management, we support innovative companies at all stages of development -- from seed to growth -- and offer a broad network of resources for entrepreneurs. We seek to partner with exceptional teams committed to excellence and innovation. http://www.prospectventures.com/
About Third Rock Ventures
Third Rock Ventures is a venture capital firm founded in 2007 with the mission to launch transformative life sciences companies. With more than $800 million and two funds under management, the firm is focused on working with passionate entrepreneurs to build exceptional companies working in areas of disruptive science that will make a difference in the lives of patients. The firm has assembled a team with deep expertise and a proven track record of building respected and successful life sciences companies. With decades of complementary, cross-functional operational and leadership experience, the Third Rock team actively engages with its portfolio companies to provide hands-on strategy and experience to successfully launch companies with the best vision, science, operations, people and culture. With offices in Boston, MA and San Francisco, CA, Third Rock is well positioned geographically to closely collaborate with its portfolio companies to achieve their goals. http://www.thirdrockventures.com
About TOPICA Pharmaceuticals, Inc.
TOPICA Pharmaceuticals, Inc. is a privately held clinical research stage pharmaceutical company focused on developing luliconazole for the treatment of onychomycosis, fungal infections of the nail. More than 35 million Americans are estimated to suffer from onychomycosis for which treatment options are limited. In addition to luliconazole's highly potent anti-fungal activity and excellent safety profile, the molecule is able to rapidly cross the nail plate reaching the site of the infection in the nail bed. In a Phase 1/2a clinical trial completed in 2011, TOPICA demonstrated the ability of its proprietary 10 percent luliconazole solution to rapidly cross the nail plate and was well tolerated by patients. The company is now focused on conducting a robust dose finding and proof of efficacy study with luliconazole in onychomycosis starting in mid 2012 with the goal of making luliconazole the first highly effective and safe topical therapy for the treatment of onychomycosis. For more information, please visit http://www.topicapharma.com.