Phathom Pharmaceuticals is working to change the GI treatment landscape and improve the lives of patients with acid-related disorders. Phathom is developing vonoprazan*, an investigational, potassium-competitive acid blocker (P-CAB). Vonoprazan has the potential to be the first gastric, anti-secretory agent from a new class approved in the United States, Europe, or Canada in over 30 years.
We are currently running a pivotal Phase 3 clinical trial in erosive gastroesophageal disease, a Phase 2 trial in nonerosive reflux disease (NERD), and also evaluating the development of vonoprazan for other acid-related disorders. In April 2021, Phathom released topline results from a pivotal Phase 3 trial in H. pylori infection and plans to file New Drug Application (NDA) submissions with the US FDA by the end of 2021.
Current limitations in GERD and H. pylori infection
Gastric acid is secreted by the hydrogen potassium ATPase (also known as the proton pump). While proton pump inhibitors (PPIs) are the current standard of care for acid-related diseases, they have limitations that result in a large, unmet medical need.
In GERD, PPI therapy is suboptimal for many patients due to the slow onset and insufficient duration of acid control, which can lead to inadequate symptom relief. Approximately 15% to 45% of GERD patients remain inadequately treated with PPIs.
In the treatment of H. pylori infection, the standard of care consists of a combination of a PPI and at least two oral antibiotics. However, increasing antibiotic resistance has resulted in declining eradication rates with PPI-based therapy.
We believe these unmet medical needs are in part driven by limitations associated with the mechanism of action and pharmacokinetics of PPIs.
*Vonoprazan is a product candidate that is under clinical study and that has not been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of vonoprazan.