Therapy Areas: Oncology
Phathom Pharmaceuticals Starts Pivotal Phase 3 Clinical Trial for Vonoprazan in Erosive Esophagitis
4 December 2019 - - US-based biopharmaceutical company Phathom Pharmaceuticals, Inc. (NASDAQ: PHAT) has initiated PHALCON-EE, the company's pivotal Phase 3 clinical trial of vonoprazan for both the healing and maintenance of healing of erosive esophagitis as well as the relief of heartburn, the company said.

PHALCON-EE is a randomised, double-blind, two-phase, multicenter Phase 3 trial that is planned to enroll approximately 1,000 patients with EE in the US and Europe.

The first phase of the trial will evaluate the efficacy and safety of vonoprazan 20 mg administered once-daily compared to lansoprazole 30 mg QD for the healing of EE for up to eight weeks.

The second phase of the trial will evaluate the efficacy and safety of vonoprazan 10 mg QD and 20 mg QD compared to lansoprazole 15 mg QD for the maintenance of healing of EE for 24 weeks. Both phases will also evaluate heartburn symptoms.

Erosive Esophagitis is a major type of gastroesophageal reflux disease characterized by erosions in the gastric mucosa caused by acidic reflux of stomach contents into the esophagus.

There are estimated to be over 65 m individuals with GERD in the US, of which approximately 30% have EE.

In addition to experiencing troubling heartburn symptoms, patients with inadequately treated EE may progress to more severe diseases including Barrett's esophagus and esophageal cancer.

Vonoprazan, is an oral small molecule potassium competitive acid blocker (P-CAB). P-CABs are a novel class of medicines that block acid secretion in the stomach.

Vonoprazan has shown rapid, potent, and durable anti-secretory effects and has demonstrated clinical benefits over standard of care treatments as a single agent in the treatment of gastroesophageal reflux disease, and in combination with antibiotics for the treatment of Helicobacter pylori (H. pylori) infection.

Phathom in-licensed the US, European, and Canadian rights to vonoprazan from Takeda, which completed 17 Phase 3 trials for vonorpazan and received marketing approval in Japan and eight other countries in Asia and Latin America.

Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders.

Phathom has licensed the exclusive rights in the United States, Europe, and Canada to vonoprazan, a novel potassium competitive acid blocker (P-CAB) in late-stage development for the treatment of acid-related disorders.