Associate Managing Editor

EpiGenesis Pharmaceuticals Inc., emerging from a refocusing, raised $23 million in its Series A round to fund clinical development of its lead product.

Labeling it a two-year financing, EpiGenesis Chief Financial Officer Joanne Leonard said the funds will be used "to bring our lead compound, EPI-12323, through Phase II proof of concept in asthma and [chronic obstructive pulmonary disorder]."

Care Capital, of Princeton, N.J., was lead investor. Investor Growth Capital, of New York; Boston Millennia Partners, of Boston; Merrill Lynch Ventures, of New York; Technology Partners, of Palo Alto, Calif.; and NJTC Venture Fund, of Mount Laurel, N.J., also participated.

Until the financing, EpiGenesis, of Princeton, survived on a little seed funding and money from collaborations, most notably one with Taisho Pharmaceuticals Co. Ltd., of Tokyo. The agreement, made public in early 2001, had a total potential of more than $100 million to EpiGenesis and focused on the asthma product EPI-2010. (See BioWorld Today, March 1, 2001.)

However, development of the drug hit a snag.

"The early [clinical] results were promising in steroid-na ve patients and patients with mild asthma," Cynthia Robinson, vice president of clinical development, told BioWorld Today. "But we didn't observe an incremental benefit in patients on inhaled steroids. Since a majority of asthma patients are treated with steroids, we decided it was in our best interest to end the program."

Opting not to put any more money into a product that might lack a certain commercial aspect, EpiGenesis met with Taisho and the companies mutually decided to terminate the alliance, Leonard said.

Moving ahead, Leonard told BioWorld Today the company restructured in November "to focus solely on the clinical development of our lead compound."

EGI-12323 was moved squarely to the front. It is an inhaled non-glucocorticoid steroid designed to target the inflammatory and airway obstruction cascade in asthma patients. The company hopes to partner the program in 2004, after the results from its Phase IIa trial are available. If the company needs additional funds before partnering, it would consider a Series B round, Leonard said.

The company also is studying the compound, which was derived from its RASON (Respiratory Antisense Oligonucleotides) platform, in combination with other drugs.

Newly appointed President and CEO Daniel Soland has more than 20 years experience in the pharmaceutical industry. He worked for 10 years with GlaxoSmithKline plc, of London, in several roles, including vice president of its U.S. pharmaceuticals biological business unit. His plans, he said, include "to focus and add as much value to 12323 as we possibly can and to have that optimal partner to take the product to licensure and commercialization."

Along with the financing, EpiGenesis appointed Jan Leschly, chair and partner at Care Capital, chairman of the company's board. It also appointed to its board Liza Page Nelson, managing director and co-head of health care investing at Investor Growth; Robert Marshal, partner at Boston Millenia; Robert Glassman, vice president of global private equity at Merrill Lynch; and Jim Glasheen, partner at Technology Partners. Rounding out the board is Soland.

The company also named Jerry Karabelas, partner at Care Capital, chairman of its scientific advisory board. Also appointed to that board were Reynold Panettieri, Sally Wenzel, William Jenkins and Francesco Patalano.

With the financing, a new CEO and president, new board members and a new scientific advisory board, there is an air of change at EpiGenesis and excitement from the management.

"What EpiGenesis brings is a tight focus on a new compound that has a low risk in clinical development," Robinson said. "We have a streamlined development path for both asthma and COPD. I am very excited about the support from our scientific advisory board because it is truly leaders in the commercial field and in the clinical development field that we have pulled together."