CINCINNATI & SAN DIEGO—Yesterday Aerpio Pharmaceuticals, Inc. announced an exclusive global license agreement with a wholly owned subsidiary of Gossamer Bio, Inc., GB004, Inc., for the development and commercialization of Aerpio’s hypoxia-inducible factor-1 alpha (HIF-1 alpha) stabilizer, AKB-4924, along with other related compounds. The arrangement combines Aerpio’s deep understanding of HIF biology with Gossamer’s experience in inflammation, immunology and inflammatory bowel disease (IBD) drug development.
Sheila Gujrathi, MD, Gossamer Bio’s President and Chief Operating Officer said, “The HIF-1 alpha stabilization mechanisms represent truly novel biology with multiple putative benefits and a potential paradigm-changing approach to treating IBD patients.”
AKB-4924 (to be known as GB004) is an investigational HIF-1 alpha stabilizer in development for IBD. Unlike other HIF stabilizers in clinical development, which stabilize HIF-2 and stimulate erythropoiesis, GB004 preferentially stabilizes HIF-1 alpha, and has profound anti-inflammatory and mucosal wound healing effects in animal models of IBD. Based on pre-clinical study results, GB004 has demonstrated several potential advantages over existing therapies for the treatment of IBD, including a possible superior efficacy and safety profile and once-daily oral route of administration.
AKB-4924 (to be known as GB004) is an investigational HIF-1 alpha stabilizer in development for IBD. Unlike other HIF stabilizers in clinical development, which stabilize HIF-2 and stimulate erythropoiesis, GB004 preferentially stabilizes HIF-1 alpha, and has profound anti-inflammatory and mucosal wound healing effects in animal models of IBD. Based on pre-clinical study results, GB004 has demonstrated several potential advantages over existing therapies for the treatment of IBD, including a possible superior efficacy and safety profile and once-daily oral route of administration.
Faheem Hasnain, Gossamer Bio’s Chairman and Chief Executive Officer stated, “We are pleased to have found GB004 after thoroughly assessing a substantial number of opportunities. This program represents an important addition to the Gossamer portfolio of drug candidates aiming to address unmet medical needs.”
To date, Aerpio has conducted a Phase 1, single ascending dose study in healthy volunteers which found GB004 to be safe and well-tolerated. In May 2018, Aerpio initiated a 24-subject, Phase 1, multiple ascending dose study to further assess the pharmacokinetics, safety and tolerability of GB004 in healthy volunteers.
To date, Aerpio has conducted a Phase 1, single ascending dose study in healthy volunteers which found GB004 to be safe and well-tolerated. In May 2018, Aerpio initiated a 24-subject, Phase 1, multiple ascending dose study to further assess the pharmacokinetics, safety and tolerability of GB004 in healthy volunteers.
Under the terms of the license agreement, Gossamer will pay Aerpio $20 million up front, potential development, regulatory, and sales milestones of up to $400 million, and royalties on worldwide net sales, which range from a high single digit to mid-teen percentage of net sales. Gossamer will be responsible for the remaining development, regulatory, and commercialization expenses for GB004.
“Gossamer is the ideal partner to maximize the potential of GB004 in IBD,” said Stephen Hoffman, MD, PhD, Chief Executive Officer of Aerpio. “The Gossamer team has a demonstrated track record of successful therapeutic development in IBD, specifically the development of Ozanimod in multiple sclerosis and IBD, as evidenced by the sale of Receptos to Celgene in 2015 for $7.2 billion. Our partnership allows us to focus our resources on our ophthalmology and diabetes programs currently in development at Aerpio.”
