Healthcare & Pharmaceutical Awards 2021

28 GHP / Healthcare and Pharmaceutical Awards 2021 , Jul21370 Pioneering a novel investigational drug to help change lives for those with gastrointestinal disorders, PhathomPharmaceuticals is a leading GI-focused pharmaceutical company committed to improving patients’ lives by going beyond to advance treatments for patients with acid-related disorders. We find out more fromPhathom’s President and CEO, Terrie Curran, about the company and its work. Leading Innovators in GI Disorder Treatments 2021 - North America Phathom Pharmaceuticals is a biopharmaceutical company headquartered in Florham Park, New Jersey, focused on the development and commercialization of novel treatments for gastrointestinal diseases and disorders. The company has in-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. Vonoprazan has the potential to be the first gastric, anti-secretory agent from a new class approved in the United States, Europe or Canada in more than 30 years. More broadly, Phathom Pharmaceuticals is working to change the GI treatment landscape and improve the lives of patients with acid-related disorders. “Over the last 30 years, the treatment landscape for acid-related disorders has remained stagnant while medical innovation has increased across the healthcare space,” she explains. “Phathom is seeking to drastically change the treatment landscape by ushering in a new era of therapies. With our lead candidate, vonoprazan, Phathom has the potential to bring innovation to a large, underserved market that has not experienced any new classes of medicine in decades.” Vonoprazan is an investigational, 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. “Realizing that there still remains significant unmet need for millions of patients suffering from highly prevalent GI disorders, Phathom was founded in the hopes of helping to address this dissatisfaction.” Phathom has a potential track to commercialization as early as next year, having recently announced positive results from two pivotal Phase 3 trials studying vonoprazan – PHALCON-HP in H. pylori infection and PHALCON-EE in erosive esophagitis (EE). In October 2021, Phathom’s PHALCON-EE trial met its primary endpoints and key secondary endpoints. The study met the primary endpoints of noninferiority for vonoprazan compared to a standard-of-care proton pump inhibitor (PPI), lansoprazole, in both healing and maintenance phases of the study. The trial also demonstrated that vonoprazan, versus lansoprazole, was fast and superior in healing EE in patients with moderate-to-severe patients at week 2, and superior in maintenance of healing in all patients and patients with moderate-to-severe disease at week 24 versus lansoprazole. Based on these positive results, Phathom remains on track to submit a new drug application (NDA) in the first half of 2022, targeting two distinct EE indications: healing of all grades of EE and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn. This news comes just after Phathom announced the submission of two NDAs for the drug in September, both for H. pylori infection. The applications request FDA approval to use vonoprazan as a dual therapy with amoxicillin and a triple therapy with amoxicillin and clarithromycin. The NDAs are based on the positive results from the company’s PHALCON- HP clinical trial, where vonoprazan-based treatments demonstrated superior eradication compared to lansoprazole-based triple therapy. “We are thrilled with the positive outcomes of both of our pivotal phase 3 studies,” Terrie said. “We believe these results further demonstrate the potential of vonoprazan and may help to significantly differentiate our product in the GI space.” The Phathom team is fuelled by the potential to help patients, the potential to improve the GI space, the potential to change lives, and the potential to apply current science to an area that is in desperate need of Innovation. “We are a nimble company with great potential and a strong passion to transform a large and dormant category. Our team is comprised of talented and relentless trailblazers who are always thinking of new ways to challenge the status quo. Phathom is a team of people who have decided that ’good enough’ is not enough and joined the organization to advance innovative treatments to potentially change the treatment paradigm and ultimately improve the lives of patients.” Amidst the global COVID-19 pandemic, Phathom continued to demonstrate strong execution and advance its clinical programs and pipeline. “We are very pleased with Phathom’s steadfast progress and ability to meet and exceed our project timelines with great results in a time of uncertainty for most of the world.” Recently, Phathom Pharmaceuticals was awarded the prestigious accolade of Best Late-Stage Biopharmaceutical Company – North America in the GHP Healthcare and Pharmaceutical Awards 2021, and Terrie elaborates to inform us that the future is looking very bright indeed for Phathom. “We are very excited about the future of Phathom. We are continuing to grow, expand our team, and advance several significant catalysts expected through 2022 that will lay the foundation for Phathom’s long-term success. There is drastic room for change in the GI treatment landscape, and Phathom is working to create that change.” Contact: Nick Benedetto, Head of Communications Company: PhathomPharmaceuticals Web: Phathom Pharmaceuticals