Phathom Pharmaceuticals Provides Clinical Trial Status Update

Phathom Pharmaceuticals, Inc. recently announced it has randomized the first new patients in each of its two Phase 3 clinical trials since temporarily pausing new patient randomization in response to the COVID-19 pandemic.

“We are pleased to have resumed enrollment and randomization of new patients in our PHALCON-EE and PHALCON-HP Phase 3 studies of vonoprazan that we temporarily paused in March due to the COVID-19 pandemic,” said Azmi Nabulsi, MD, Chief Operating Officer of Phathom. “Utilizing relevant practice guidelines, our teams have been working closely with our investigators to determine the timing of individual trial sites to safely resume screening and randomization of new patients in our PHALCON studies. We are encouraged by the eagerness and readiness of these sites to enroll new patients into our programs and are excited to continue to advance the clinical development of vonoprazan.”

In March, Phathom temporarily paused new patient randomization in its PHALCON-EE and PHALCON-HP clinical trials. The decision was not based on any study-related COVID-19 infections or other safety events but rather was in support of global efforts to combat the spread of the SARS-CoV-2 coronavirus.  During the temporary pause, Phathom worked closely with sites to ensure patients who were already enrolled and randomized in the PHALCON-EE and PHALCON-HP studies could remain safely in the trial with as little disruption as possible. Phathom has not experienced any interruptions to clinical trial supply, including manufacturing and the overall supply chain.

Phathom continues to closely monitor the COVID-19 situation and, at this time, continues to expect to provide top-line data from the PHALCON-EE and PHALCON-HP trials in 2021.

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 the potential to have rapid, potent, and durable anti-secretory effects as a single agent in the treatment of gastroesophageal reflux disease (GERD) and in combination with antibiotics for the treatment of Helicobacter pylori (H. pylori) infection. The US FDA has designated vonoprazan as a qualified infectious disease product (QIDP) and awarded Fast Track status for the treatment of H. pylori infection in combination with both amoxicillin and clarithromycin and with amoxicillin alone. Phathom in-licensed the US, European, and Canadian rights to vonoprazan from Takeda, which completed 18 Phase 3 trials for vonoprazan and received marketing approval in 13 countries in Asia and Latin America.

PHALCON-EE is a randomized, double-blind, two-phase, multicenter Phase 3 trial that is planned to enroll approximately 1,000 patients with erosive esophagitis (EE) in the US and Europe. The first phase of the trial is evaluating the efficacy and safety of vonoprazan 20 mg administered once-daily (QD) compared to lansoprazole 30 mg QD for the healing of EE for up to 8 weeks. The second phase of the trial is evaluating 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 are also evaluating heartburn symptoms.

PHALCON-HP is a randomized, multicenter, Phase 3 trial that is planned to enroll approximately 975 patients with H. pylori infection in the US and Europe. Participants are being randomized 1:1:1 to one of three arms: vonoprazan 20 mg administered twice a day (BID) and amoxicillin 1g administered three times a day (TID); vonoprazan 20 mg BID, amoxicillin 1 g BID and clarithromycin 500 mg BID; and lansoprazole 30 mg BID, amoxicillin 1 g BID and clarithromycin 500 mg BID. Each treatment regimen is being administered for 14 days. PHALCON-HP is evaluating the percentage of patients with successful eradication of H. pylori infection.

Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders. Phathom has in-licensed the exclusive rights in the US, Europe, and Canada to vonoprazan, a novel potassium competitive acid blocker (P-CAB) in late-stage development for the treatment of acid-related disorders. For more information, visit www.phathompharma.com or follow the company on LinkedIn at www.linkedin.com/company/phathompharma.