Phase III PHALCON-EE trial of Takecab meets its primary and key secondary endpoints in erosive oesophagitis.

The primary endpoint of the Healing Phase was non-inferiority of vonoprazan 20 mg compared to lansoprazole 30 mg in the percentage of all patients who have complete healing of EE by Week 8. Vonoprazan met the Healing Phase primary endpoint with a healing rate of 93% compared to 85% for lansoprazole (p<0.0001). in a preplanned exploratory superiority test, the difference between vonoprazan and lansoprazole was also significant (p><0.0001).></0.0001).></0.0001).>

Vonoprazan also met the primary and all secondary endpoints in the Maintenance Phase. The primary endpoint of the Maintenance Phase was non-inferiority of vonoprazan 10 mg and 20 mg compared to lansoprazole 15 mg in the percentage of all patients who maintained healing of EE through Week 24. Both vonoprazan doses met the Maintenance Phase primary endpoint of non-inferiority while also meeting the secondary comparison demonstrating superiority of maintenance of healing versus lansoprazole (79% for vonoprazan 10 mg, 81% for vonoprazan 20 mg compared to 72% for lansoprazole 15 mg) (p<0.0001 for both non-inferiority comparisons; p="0.0218" for vonoprazan 10 mg superiority comparison; p="0.0068" for vonoprazan 20 mg superiority comparison). overall, the safety results for vonoprazan observed in phalcon-ee were consistent with the results observed in prior clinical studies.></0.0001>

Based on the positive PHALCON-EE data, Phathom plans to submit an NDA to the FDA seeking the following indications: healing of all grades of EE and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn.