cAMPfield Therapeutics is preparing to advance prifemilast, an oral phosphodiesterase type 4 (PDE4) inhibitor, into mid-stage clinical testing for inflammatory bowel disease (IBD), with plans to launch global studies in both ulcerative colitis and Crohn’s disease.
The San Diego-based biotechnology company will begin a global Phase 2b trial in patients with moderate-to-severe ulcerative colitis and a global Phase 2 study in Crohn’s disease. Prifemilast, also known as HY1999 or HPP737, was licensed from China-based Newsoara Biopharma, with cAMPfield securing exclusive global development and commercialization rights outside Greater China.
According to the company, more than 700 individuals have received prifemilast in clinical trials to date, including more than 250 participants who were exposed to the treatment for one year. cAMPfield said treatment discontinuation rates were comparable to placebo, supporting what it described as a tolerable profile for the candidate.
The company also highlighted results from a Newsoara-conducted Phase 3 study in plaque psoriasis. Newsoara is currently running a second late-stage trial intended to support a potential new drug application. cAMPfield noted that the psoriasis program provides additional clinical experience with the drug as it moves into studies for inflammatory bowel diseases.
Prifemilast is designed to selectively inhibit PDE4B, a subtype that cAMPfield said is most strongly associated with anti-inflammatory activity. The company stated that the drug has shown greater selectivity for PDE4B than PDE4D, a subtype believed to contribute to dose-limiting adverse effects. Systemic PDE4 inhibition has historically been associated with gastrointestinal side effects such as nausea, vomiting and diarrhea, which can be particularly relevant in diseases affecting the digestive tract.
The company was formed by Mountainfield Venture Partners together with a group of biotechnology and pharmaceutical industry veterans. Its founders include Asit Parikh, chief executive officer of Moma Therapeutics and former head of gastroenterology at Takeda, where he led development of Entyvio; Keith Usiskin, former vice president and head of gastroenterology at Celgene and Bristol Myers Squibb and former development head for Otezla and Zeposia in IBD; and Mark Stenhouse, former chief operating officer of Prometheus Biosciences and former vice president of U.S. sales and marketing at AbbVie.
cAMPfield is led by Chief Executive Officer Bill Gerhart, who is also a senior adviser at Mountainfield. Gerhart said, “Despite the availability of more than a dozen approved therapies for IBD, most patients fail to achieve deep and durable remission, while others discontinue or switch treatments because of limitations in safety or long-term effectiveness.”
To support development of the program, cAMPfield launched with $180 million in Series A financing. The round was led by Frazier Life Sciences and included participation from Deep Track Capital, Forbion, Abingworth, Venrock, Longitude Capital, Novo Holdings and RA Capital.
The company’s formation follows a series of transactions involving prifemilast. Newsoara initially obtained China rights to the drug from vTv Therapeutics in 2018 and, earlier this year, expanded its position by acquiring the remaining rights to the candidate. cAMPfield subsequently obtained rights to develop and commercialize the therapy outside Greater China.
cAMPfield is preparing to launch mid-stage clinical trials evaluating Prifemilast as a potential treatment for ulcerative colitis and Crohn’s disease. The planned studies represent an important step forward for cAMPfield as the company expands its efforts in inflammatory bowel disease (IBD) research and development.
cAMPfield Advances Prifemilast Development
The upcoming trials are expected to provide valuable insights into the safety, efficacy, and therapeutic potential of Prifemilast. By progressing into mid-stage development, cAMPfield is moving closer to determining whether the investigational therapy can address the complex challenges associated with chronic inflammatory bowel conditions.
Ulcerative colitis and Crohn’s disease affect millions of people worldwide and often require long-term management. Through the development of Prifemilast, cAMPfield aims to provide a new treatment option that may help improve disease control and patient quality of life.
The initiation of mid-stage studies further strengthens the development pipeline of cAMPfield. Advancing promising candidates through clinical evaluation is a critical component of the company’s strategy to build a diversified portfolio of therapies targeting inflammatory and immune-mediated disorders.
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