A Triangle startup led by a former Biogen (Nasdaq: BIIB) executive is raising capital to advance its lead drug into clinical trials.
APIE Therapeutics has kicked off a Series A round with the aim of raising $35 million to finish up preclinical work that would enable the company to submit an investigational new drug application to the U.S. Food and Drug Administration. The company could move into a phase 1 study about 18 months after closing the round.
Despite a difficult macroeconomic environment for startups to raise money, CEO Esther Alegria remains positive about the company's prospects.
"When you have the right science, the right team and the right disease target, investments are still happening," Alegria said.
Alegria, who leads an experienced team of five employees, spent more than two decades working with large pharmaceutical companies, such as Biogen and Wyeth – which was acquired by Pfizer (NYSE: PFE). Alegria has seen more than 20 programs move from research and development to commercialization.
After a decade at Biogen, including time as the company's senior vice president of global manufacturing, Alegria opted to leave the world of big corporate pharma, and begin helping smaller biotechs. As part of this effort, Alegria returned to North Carolina — where she previously lived while working at what's now a Pfizer facility in Sanford and as a plant manager for Biogen in Research Triangle Park.
"When I decided to start helping small companies – using the knowledge that I have acquired in my career – North Carolina was the right place to come back," Alegria said.
Alegria began working with startups throughout the Triangle before coming upon an opportunity with RTI International. The nonprofit research institute was looking for an entrepreneur who could take on a portfolio of compounds that could be developed into drugs to treat a range of diseases, including pulmonary fibrosis.
Motivated by the technology's potential, Alegria entered a bidding process and in 2020 reached a deal with RTI. Alegria formed APIE, which received global exclusive rights to RTI's portfolio of compounds, and in exchange the research institute received the opportunity to land potential milestone and royalty payments if APIE is successful in developing and commercializing a drug.
RTI, Alegria and and a couple of board members put cash into the company to get started. APIE also received a $500,000 business research loan from the North Carolina Biotechnology Center, and landed about $2 million for seed funding to move the company's lead program through most of its preclinical work. The company is developing its lead compound as a treatment for systemic sclerosis, which is a group of rare diseases that involves the hardening and tightening of a patient's skin.
Alegria has built out a small team, while also working with a board of directors and two advisory boards. The company has also set up an office space at First Flight Venture Center on Davis Drive in Research Triangle Park.
If APIE raises the $35 million, the company would be supported through the end of 2025 or into early 2026. Alegria said this would cover the development of the company's lead program through a phase 2 study. At that point, APIE would look to find a partner, like a large pharma company, that would move the drug through a pivotal trial and into a commercial launch.
If this approach is successful, the company could repeat the process with some of the other hundreds of compounds in its portfolio. This approach enables to company to have a greater impact on new drug development and innovation, Alegria said.
"What we’re planning is to become an asset for big pharma where we identify a clinical candidate, get it to proven efficacy ... and then find a partner that can take it to large-scale clinical studies," Alegria said.
