dm+d

Unassigned

New Medicines

Helicobacter pylori infection

Information

New molecular entity
Phathom Pharmaceuticals
Phathom Pharmaceuticals

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Pre-registration (Filed)
Sep 21Phathom has requested priority review from the FDA. Vonoprazan triple therapy and vonoprazan dual therapy has qualified infectious disease products (QIDP) status in the US [7].
Sep 21Phathom files two new drug applications (NDAs) to the FDA for the use of vonoprazan in combination with amoxicillin and clarithromycin (vonoprazan triple therapy) and vonoprazan in combination with amoxicillin (vonoprazan dual therapy) as a treatment for Helicobacter pylori (H. pylori) infection in adults. If approved, Phathom plans US launch in in H2 2022 (no plans for filings in other countries mentioned although Phathom has in-licensed exclusive rights in the US, Europe, and Canada to vonoprazan) [7].
Jun 21New website, rethinkGIacid.com, launched by Phathom to provide education for healthcare professionals in treating H.pylori prior to vonoprazan´s FDA submissions [6].
Apr 21Following positive PIII trial results, NDA submission in the US is planned for Q4 2021, where the drug has been granted Fast Track designation for H.pylori by the FDA [5]

Category

A potassium competitive acid blocker (P-CAB) that inhibits gastric acid secretion by binding to H+,K+-ATPase. P-CABs bind reversibly to the enzyme, whereas PPIs bind irreversibly [1]
95% of duodenal and 70–80% of gastric ulcers are associated with H.pylori infection. Hpylori is also a strong risk factor for certain cancers. 1 in 5 patients fail initial therapy for H.pylori eradication. The lifetime risk of recurrence for gastric ulcers is 60% if the person remains H.pylori positive, but 5% following eradication of H.pylori. The lifetime risk of recurrence for duodenal ulcers is 80% if the person remains H.pylori positive, but 5% following eradication of H.pylori [2,3]
Helicobacter pylori infection
Oral

Trial or other data

Apr 21Company announce the PIII PHALCON-HP trial has completed and met all its primary and secondary endpoints. In the modified intent-to-treat (mITT) population, H. pylori eradication rates were 84.7% with vonoprazan triple therapy and 78.5% for vonoprazan dual therapy vs 78.8% with lansoprazole triple therapy (p2.0%) reported in the vonoprazan triple therapy, vonoprazan dual therapy, and lansoprazole triple therapy arms, respectively, were diarrhoea (4.0%, 5.2%, and 9.6%), dysgeusia (4.3%, 0.6%, and 6.1%), nausea (1.7%, 1.7% and 2.6%), headache (2.6%, 1.4%, 1.4%) and vaginal infections (2.3%, 0.9%, 0.3%). Overall rates of discontinuation due to adverse events were 2.3% for vonoprazan triple therapy-treated patients, 0.9% for vonoprazan dual therapy-treated patients, and 1.4% for lansoprazole triple therapy-treated patients. Full results from the PHALCON-HP study will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal [5].
Sep 19PIII trial (pHALCON-HP; EudraCT2019-002668-28; NCT04167670) started. The multicentre, randomised trial will investigate efficacy and safety of vonoprazan in adult participants with H.pylori infection (n=975 planned), comparing open-label dual therapy with vonoprazan 20mg twice daily and amoxicillin 1g three times daily and double-blind dual therapy with vonoprazan 20mg twice daily with amoxicillin 1g twice daily and clarithromycin 500mg twice daily vs lansoprazole triple-therapy with lansoprazole 30mg twice daily with amoxicillin 1g twice daily and clarithromycin 500mg twice daily. Participants with clarithromycin or amoxicillin resistant strains of H.pylori will be excluded at baseline. Primary outcome measure is number of participants with successful H.pylori eradication after 14 days treatment to be determined by carbon-Urea breath test 4 weeks after completion of treatment [3,4].

Erosive oesophagitis - healing and maintenance, also relief of heartburn

Information

Licence extension / variation
Phathom Pharmaceuticals
Phathom Pharmaceuticals

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Small molecule potassium competitive acid blocker (P-CAB) - blocks gastric acid secretion
Oesophageal reflux is two to three times more common in men than in women. Symptoms of gastro-oesophageal reflux are common; about 25% of adults experience heartburn and 5% have symptoms daily. About 8% will have moderate or severe oesophagitis [1].
Erosive oesophagitis - healing and maintenance, also relief of heartburn
Oral