Calliditas Therapeutics AB (publ) (“Calliditas”) today announced that it will host a Key Opinion Leader (KOL) Perspectives webinar on the Pathophysiology and Treatment of IgA Nephropathy in Clinical Practice on Wednesday, March 10, 2021 at 10:00am Eastern Time.
The webinar will feature a presentation from KOL Richard Lafayette, M.D., F.A.C.P., Stanford Healthcare, who will discuss the pathophysiology of IgA nephropathy, the connection between the gut and kidney, and how Calliditas’ lead clinical candidate, Nefecon, might be used in clinical practice, should it be approved. Dr. Lafayette will be available to answer questions following the formal presentation.
Calliditas management will also give a corporate update and present data from the global Phase 3 NefIgArd trial. The pivotal NefIgArd trial consists of two parts. Part A, which was designed to support regulatory submissions, provided data on the efficacy and safety of Nefecon. Calliditas read out positive topline data from Part A of the trial on 8 November 2020, announcing that the study met its primary endpoint, reduction in proteinuria, and key secondary endpoint stabilization of eGFR. It also showed that Nefecon was generally well-tolerated. Part B is designed to be a confirmatory post-market approval observational trial to confirm long-term renal protection, and was fully recruited in January 2021.
Dr. Lafayette is Professor of Medicine (Nephrology) and Director of the Stanford Glomerular Disease Center at Stanford University Medical Center in Stanford, CA. His 25-year career in nephrology spans general nephrology, transplant nephrology, and focuses on glomerular disease. During this time, he has served as Senior Associate Chair of Medicine for six years and Clinical Chief of Nephrology for more than a decade. Dr. Lafayette was a member of the first Kidney News Editorial Board and is a member of the ASN Glomerular Diseases Advisory Group.
For further information, please contact:
Marie Galay, IR Manager, Calliditas
The information was sent for publication, through the agency of the contact persons set out above, on March 4, 2021 at 2:30 p.m. CET.
Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas’ lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to conduct clinical trials with NOX inhibitors in PBC and oncology. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT). Visit www.calliditas.com for further information.
Nefecon is a patented oral formulation of a potent and well-known active substance – budesonide – for targeted release. The formulation is designed to deliver the drug to the Peyer’s patch region of the lower small intestine, where the disease originates, as per the predominant pathogenesis models. Nefecon is derived from the TARGIT technology, which allows for the substance to pass through the stomach and intestine without being absorbed, and to be released in a pulse like fashion only when it reaches the lower small intestine.
The combination of dose and optimized release profile is required to be effective in patients with IgA nephropathy, as shown in a large Phase 2b trial, completed by the company. In addition to its potent local effect, another advantage of using this active substance is that it has very low bioavailability, i.e. around 90% of it is inactivated in the liver before it reaches the systemic circulation. This means that a high concentration can be applied locally where needed but with only very limited systemic exposure and side effects.