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Cinclus Pharma receives QIDP designation
Prenumeration
Cinclus Pharma Holding AB (publ), a biopharmaceutical company focused on the development of a novel treatment for gastroesophageal reflux disease (GERD), today announces that the US Food and Drug Administration (FDA) has granted a Qualified Infectious Disease Product (QIDP) designation for the company’s leading drug candidate linaprazan glurate for the treatment of Helicobacter pylori (H. pylori) infection allowing an additional five years of U.S. data exclusivity given that linaprazan glurate receives a marketing approval for the indication.
The QIDP designation is intended to encourage development of new drugs for the treatment of serious or life-threatening infections. Under FDA's Generating Antibiotic Incentives Now (GAIN) Act, a QIDP designation allows for fast-track status and priority review, potentially leading to a shorter New Drug Application (NDA) review time by the FDA, and, if approved, an additional five years of U.S. data exclusivity on top of the standard exclusivity period.
“We are very pleased to receive QIDP designation from the FDA for linaprazan glurate and are looking forward to working with the FDA to rapidly make this P-CAB, linaprazan glurate, available to patients. We are planning for phase III studies in H. pylori and GERD and are excited to get this important recognition from the FDA, potentially giving us a total of ten years of US data exclusivity from registration, the same as in EU,” said Christer Ahlberg, CEO of Cinclus Pharma.
The work to finalize the phase II clinical trial with linaprazan glurate for the treatment of severe erosive GERD (eGERD) that has been conducted in the USA and Europe is currently ongoing. The top-line result will be presented during the fall 2022. The study results will form the basis for the study design of the upcoming pivotal phase III studies on GERD and H. pylori infection that are expected to begin in 2023.
About H. pylori infection
H. pylori is a bacterial pathogen that continues to be a major health problem worldwide. The World Health Organization has listed H. pylori among the sixteen antibiotic-resistant bacteria posing the greatest threat to human health. Linaprazan glurate has demonstrated superior gastric acid suppression over PPIs and will facilitate the antibiotic efficacy and subsequently improving the eradication rate of H. pylori infection.