Amplyx secures $40.5m in Series B financing to support clinical development of APX001

The round was led by RiverVest Venture Partners, and included investments by New Enterprise Associates, BioMed Ventures and individual investors.

Amplyx will use the funding to advance the clinical development of APX001, the company’s broad-spectrum antifungal agent to treat life threatening fungal infections.

The company plans to initiate Phase 1 clinical trials of APX001 in 2016 to support a Phase 2 program in candidiasis, invasive aspergillosis and rare molds. APX001 has a novel mechanism of action and has shown broad-spectrum activity in animal models of infection by common species of Candida and Aspergillus, as well as high potency against rare molds.

Amplyx is developing both intravenous and oral formulations of APX001 to address the need for hospital-based administration, as well as continued convenient administration after hospital discharge.

Amplyx Pharmaceuticals president and CEO Mike Grey said: "There is an urgent unmet need for new treatments for fungal infections which increasingly impact immuno-compromised patients who are at high risk of contracting these difficult-to-treat, and often deadly, infections.

"There hasn’t been a new class of antifungal drug approved since 2001, and many existing antifungal agents are difficult to use, often poorly tolerated or ineffective due to the rise of drug resistant strains."

In association with the financing, Niall O’Donnell, Ph.D., managing director, RiverVest Venture Partners, and Ed Mathers, partner, New Enterprise Associates, were named to Amplyx’s board of directors.

The following management team has been retained to lead the company, and will join Amplyx founder and chief scientific officer, Mitchell Mutz, Ph.D., as well as a number of experienced antifungal/drug development experts:

Mike Grey, president and CEO, is a venture partner with Pappas Ventures. He was previously president and CEO of Lumena Pharmaceuticals, acquired by Shire in 2014.
Ciara Kennedy, Ph.D., chief operating officer, joins Amplyx from Shire where she was vice president, head of cholestatic liver disease. Dr. Kennedy previously led the clinical development programs she initiated as chief operating officer, Lumena Pharmaceuticals.
Susan Dube, vice president, business development and administration, was previously vice president of corporate development at Lumena Pharmaceuticals before its acquisition by Shire.

"Several members of Amplyx’s management team have worked together previously on a number of successful ventures and have the vital experience necessary to execute the clinical development of APX001, including leadership in obtaining multiple drug approvals," said Dr. O’Donnell.

"The combination of this seasoned management team with great working relationships and a promising asset in a space with significant unmet need makes Amplyx a highly attractive company."

The company will be eligible to pursue an accelerated regulatory pathway for APX001 under the Generating Antibiotics Incentives Now (GAIN) Act, which provides Fast-Track and priority FDA review of a qualified infectious disease product, as well as potential market authorization in the U.S. with a limited clinical trial database. The GAIN Act also extends the period of regulatory exclusivity by five years during which antifungals that treat serious or life-threatening infections can be sold without generic competition.

"APX001 has the potential to transform the antifungal treatment landscape by providing a much needed tool to address some of the most deadly and hard-to-treat fungal infections which impact more than 600,000 patients worldwide each year," said Mr. Mathers.

"The combination of a potentially transformational therapy with a winning team that has previously successfully executed is a recipe for a great potential return on our investment."