FDA Approves Innovative Combination Therapy to Eradicate Helicobacter Pylori Infection

Recently, Phathom Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Voquezna Triple Pak (Vonolaxan, Amoxicillin, Clarithromycin Triple Combination) and Voquezna Dual Pak (Vonolaxan, Amoxicillin Dual Combination) for the treatment of Helicobacter pylori infection in adults. The press release states that both combinations contain vornoxan, a "first-in-class" potassium-competitive acid blocker that is the first derived from a new drug class approved in the U.S. in more than 30 years. Innovative acid suppression therapy.

About 50% of the world's population is infected with Helicobacter pylori. Chronic inflammation triggered by H. pylori infection can lead to a range of diseases in infected individuals, including dyspepsia, peptic ulcer disease, gastric cancer, and mucosa-associated lymphoid tissue (MALT) lymphoma. Acid suppression therapy has been one of the mainstays of the treatment regimen for H. pylori infection, which enhances the effect of antibiotics. More potent acid-suppressing drugs, such as vonolaxan, may improve eradication rates with current treatment regimens.

Vonolaxen is a novel potassium ion-competitive acid blocker (P-CAB), which can competitively block the binding of potassium ions to hydrogen/potassium ATPase, thereby rapidly inhibiting gastric acid secretion. Due to its long half-life and longer duration of action, vonoprazine is regarded as a potent long-acting proton pump inhibitor (PPI). The FDA has previously granted Qualified Infectious Disease Product Designation (QIDP) and Fast Track designation to vonoprazan triple and dual combination therapy for the treatment of H. pylori infection.

FDA approval is based on results from a pivotal Phase 3 clinical trial involving 1,046 patients. Trial results showed that the triple- and dual-combination regimens of vonoprazol met the trial's primary endpoint, achieving non-inferiority criteria for eradication rates compared with lansoprazole-based triple-combination therapy. In the modified intention-to-treat population (mITT), eradication rates were 84.7% for the vonorasen triple combination, 78.5% for the dual combination, and 78.8% for the lansoprazole triple combination.

In the entire patient population including clarithromycin-resistant H. pylori infection, the eradication rate of the triple combination of vonoprazol was 80.8% and that of the dual combination therapy was 77.2%, both superior to those of the triple combination therapy of lansoprazole ( 68.5%).

"The approval of the Voquezna regimen gives physicians and patients two treatment options. They have demonstrated superior eradication in the entire patient population compared to the proton pump inhibitor lansoprazole-based combination therapy in pivotal clinical trials. "Helicobacter pylori eradication rates are declining due to antibiotic resistance, inadequate levels of acid suppression, and complex treatment regimens," said Terrie Curran, Phathom's President and CEO. "Patients need new treatments that address the limitations of existing treatments. , we look forward to bringing Vonolaxan-based treatment options to the millions of people with H. pylori infection."