Phathom Pharmaceuticals Inc. (NASDAQ: PHAT) announced that vonoprazan met the primary endpoints and core secondary superiority endpoints in PHALCON-EE, a vital third phase study evaluating vonoprazan to Iansoprazole in erosive esophagitis treatment.
Phathom to submit NDA based on PHALCON-EE results
The company proposes submitting a New Drug Application (NDA) to the US FDA based on the positive PHALCON-EE data for the following indications: Healing of all degrees of EE and heartburn relief and maintenance of healing of all grades of EE and heartburn relief.
Phathom’s CEO, Terrie Curran, said, “The PHALCON-EE results are a major milestone for Phathom and for the 20 million Americans suffering from erosive esophagitis. The results further solidify vonoprazan’s potential to be the first major innovation in the U.S. and European GERD market in more than 30 years. The results demonstrated that vonoprazan is superior to a standard of care PPI across a broad range of clinically relevant endpoints in the study, importantly including the maintenance of healing erosions at 24 weeks for all EE patients.”
Curran added, “We are excited about the potential for vonoprazan to satisfy the large unmet needs of so many patients and set a new treatment paradigm in EE. We thank the patients, physicians, and clinical sites who participated in the PHALCON-EE study during the height of the COVID-19 pandemic, and we look forward to submitting an NDA and, if approved, making this treatment available for EE patients.”
The study met primary and secondary healing endpoints
Vonoprazan met the primary endpoint with a 93% healing rate relative to 85% for Lansoprazole. Also, in a preplanned exploratory superiority test, there was a significant difference between Iansoprazoloe and vonoprazan. Notably, vonoprazan attained secondary superiority healing endpoint in patients with the moderate-to-severe disease after two weeks. Also, Vonoprazan fulfilled the secondary goal of demonstrating non-inferiority to lansoprazole 30 mg in terms of the mean percentage of 24-hour heartburn-free days during the healing period.
