Aerpio entertains and invites partnering where mutually beneficial to both parties and where partnering is in the best interest to the development of the drug.
Aerpio IBD Drug Licensed to Gossamer Bio:
AKB-4924, now GB004, was licensed to Gossamer Bio in June 2018. On May 12, 2020 Aerpio and Gossamer Bio announced an amended license agreement which consisted of a $15 million one-time payment to Aerpio (in addition to the original upfront payment of $20 million), development and commercial milestones of $90 million and a tiered royalty of low to mid-single digits. The amended license retains the 20% participation right on any GB004 transaction as stated in the original agreement. The amended license facilitates the further development of GB004 by Gossamer Bio and supports Aerpio’s ability to progress the Aerpio pipeline.
GB004 is an investigational unique small molecule inhibitor of prolyl-hydroxylase domain enzymes (PHDs). PHDs are key regulators of hypoxia inducible factor-1 alpha (HIF-1 alpha), which, when dysregulated, has been shown to exacerbate inflammation and disrupt intestinal epithelial barrier function. By inhibiting PHDs, GB004 stabilizes HIF-1 alpha leading to potential resolution of inflammation and restoration of epithelial barrier function. The Phase 1 clinical trials on GB004 were recently completed and further development is planned as a once-daily, oral treatment for inflammatory bowel disease (IBD).
Gossamer Bio has progressed GB004 over the past year including completing the following steps:
- A Phase 1 safety study in healthy volunteers was recently completed, in which the drug was observed to be generally well tolerated with no serious adverse events reported to date.
- An Investigational New Drug Application (IND) for GB004 is now active, following a first quarter 2019 filing with the U.S. Food and Drug Administration (FDA).
- A Phase 1b study in active mild-to-moderate ulcerative colitis was recently completed in 2nd quarter 2020 by Gossamer Bio.
Gossamer Bio is now working on tablet development to support an upcoming Phase 2 study also in ulcerative colitis patients.