Calliditas Therapeutics to Present at the American Society of Nephrology Kidney Week

STOCKHOLM, Nov. 4, 2025 /PRNewswire/ -- Calliditas Therapeutics (Calliditas), an Asahi Kasei company, announced today that new data will be presented at the 2025 American Society of Nephrology Kidney Week, taking place from November 6 to 9 in Houston, Texas.

The presentations will include new secondary analyses from the Phase 3 NefIgArd study of Nefecon (marketed as TARPEYO^® [budesonide] delayed-release capsules in the United States in patients with primary immunoglobulin A nephropathy [IgAN] who are at risk for disease progression) as well as initial demographics of the PERFORM registry of IgAN patients that have received TARPEYO. Additional real-world treatment and management evidence, derived from the Veterans Health Administration and the Cure Glomerulopathy Network (CureGN) registry, will also be presented.

Data from a Phase 2a, randomized, double-blind, placebo-controlled trial studying setanaxib for the treatment of Alport Syndrome, will be presented in a High-Impact Clinical Trials session on November 8. Alport Syndrome is a rare genetic kidney disease resulting from mutations in collagen type IV genes that can lead to progressive loss of kidney function and end-stage kidney disease.

A total of eight abstracts were accepted for presentation, including one selected as a High-Impact Clinical Trial, one oral presentation, five poster presentations, and one informational poster.

High-impact Clinical Trial:

Abstract No. 3345 
Title: "Safety and preliminary efficacy findings from a Phase 2a randomized, double-blind, placebo-controlled trial of setanaxib in patients with Alport syndrome"
Date and time: November 8, 10 am to 12 pm CT (presentation scheduled for 10:30-10:45 am)
Location: Hall A
Presenter: Daniel Gale, University College London

Oral Presentation:

Abstract No. SA-OR047
Title: "Duration of Absolute Proteinuria Response with Nefecon in Patients with Primary IgAN: Results from the Two-Year NefIgArd Trial"
Date and time: November 8, 4:30 to 6 pm CT (presentation scheduled for 4:40-4:50 pm)
Location: Room 310A
Presenter: Brad Rovin, The Ohio State University Wexner Medical Center

Poster Presentations:

Abstract No. FR-PO0804
Title: "Absolute Proteinuria over Time with Nefecon vs. Placebo in Patients with IgAN: Results from the Phase 3 NefIgArd Trial"
Date and time: November 7, 10 am to 12 pm CT
Presenter: Heather Reich, University of Toronto

Abstract No. FR-PO0849
Title: "Real-World Treatment for IgA Nephropathy in the Veterans Health Administration"
Date and time: November 7, 10 am to 12 pm CT
Presenter: Lucile Gregg, Baylor College of Medicine

Abstract No. SA-PO0789
Title: "Creation and Initial Demographics of the PERFORM Patient Registry: Novel Real-World Registry of Patients Treated for IgAN in the United States"
Date and time: November 8, 10 am to 12 pm CT
Presenter: Russell Jones, Calliditas Therapeutics

Abstract No. SA-PO0804
Title: "Kidney outcomes in immunoglobulin A nephropathy (IgAN) across the age spectrum in the Cure Glomerulopathy Network (CureGN)"
Date and time: November 8, 10 am to 12 pm CT
Presenter: Myda Khalid, Indiana University School of Medicine

Abstract No. SA-PO0840
Title: "Therapies for Immunoglobulin A Nephropathy (IgAN) in Cure Glomerulopathy Network (CureGN)"
Date and time: November 8, 10 am to 12 pm CT
Presenter: Terri Madison, Madison Epi Solutions LLC

Abstract No. INFO14-TH
Title: "Investigating Extended Nefecon Treatment Beyond Nine Months in Patients with IgAN: The Phase 4 NefXtend Trial"
Date and time: November 6, 10 am to 12 pm CT (display only)

Kidney Week is the world's premier nephrology meeting, hosted by the American Society of Nephrology (ASN), that brings together thousands of kidney health professionals to share the latest advances in kidney science, research, and treatments.

About TARPEYO^® /Kinpeygo^®
TARPEYO is an oral 4mg delayed-release formulation of budesonide, designed to dissolve in the pH of the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, including the Peyer's patches, which are responsible for the production of galactose-deficient IgA1 antibodies (Gd-Ag1), causing IgA nephropathy.

About Primary Immunoglobulin A Nephropathy
Primary immunoglobulin A nephropathy (IgA nephropathy or IgAN or Berger's Disease) is a rare, progressive, chronic immune-mediate disease that attacks the kidneys and occurs when galactose-deficient IgA1 is recognized by autoantibodies, creating IgA1 containing immune complexes that become deposited in the glomerular mesangium of the kidney. This deposition in the kidney can lead to progressive kidney damage, potentially resulting in end-stage kidney disease. IgAN most often develops between late teens and late 30s.

IMPORTANT SAFETY INFORMATION

INDICATION
TARPEYO is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
TARPEYO is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of TARPEYO. Serious hypersensitivity reactions, including anaphylaxis, have occurred with other budesonide formulations.

WARNINGS AND PRECAUTIONS
Hypercorticism and adrenal axis suppression: When corticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Corticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to surgery or other stress situations, supplementation with a systemic corticosteroid is recommended. When discontinuing therapy or switching between corticosteroids, monitor for signs of adrenal axis suppression.

Patients with moderate to severe hepatic impairment (Child-Pugh Class B and C respectively) could be at an increased risk of hypercorticism and adrenal axis suppression due to an increased systemic exposure to oral budesonide. Avoid use in patients with severe hepatic impairment (Child-Pugh Class C). Monitor for increased signs and/or symptoms of hypercorticism in patients with moderate hepatic impairment (Child-Pugh Class B).

Immunosuppression and Increased Risk of Infection: Corticosteroids, including TARPEYO, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can: reduce resistance to new infections, exacerbate existing infections, increase the risk of disseminated infections, increase the risk of reactivation or exacerbation of latent infections, and mask some signs of infection. Corticosteroid-associated infections can sometimes be serious. Monitor for infection and consider TARPEYO withdrawal as needed.

Avoid corticosteroid therapy, including TARPEYO, in patients with active or quiescent tuberculosis or hepatitis B infection; untreated fungal, bacterial, systemic viral, or parasitic infections; ocular herpes simplex; or Kaposi's sarcoma. Avoid exposure to active, easily-transmitted infections (e.g., chickenpox, measles). Corticosteroid therapy may decrease the immune response to some vaccines.

Other corticosteroid effects: TARPEYO is a systemically available corticosteroid and is expected to cause related adverse reactions. Monitor patients with hypertension, prediabetes, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where corticosteroids may have unwanted effects.

ADVERSE REACTIONS
In clinical studies, the most common adverse reactions with TARPEYO (occurring in ≥5% of TARPEYO treated patients, and ≥2% higher than placebo) were peripheral edema (17%), hypertension (12%), muscle spasms (12%), acne (11%), headache (10%), upper respiratory tract infection (8%), face edema (8%), weight increased (7%), dyspepsia (7%), dermatitis (6%), arthralgia (6%), and white blood cell count increased (6%).

DRUG INTERACTIONS
Budesonide is a substrate for CYP3A4. Avoid use with potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and cyclosporine. Avoid ingestion of grapefruit juice with TARPEYO. Intake of grapefruit juice, which inhibits CYP3A4 activity, can increase the systemic exposure to budesonide.

USE IN SPECIFIC POPULATIONS
Pregnancy: The available data from published case series, epidemiological studies, and reviews with oral budesonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with IgAN. Infants exposed to in-utero corticosteroids, including budesonide, are at risk for hypoadrenalism.

Please see Full Prescribing Information

About Setanaxib
Setanaxib is a novel enzyme-dependent hydrogen peroxide depleting agent with anti-fibrotic and anti-inflammation properties. Setanaxib is in development for fibrotic rare diseases, such as Alport Syndrome, where targeting inflammation and fibrosis may potentially slow disease progression.

About Calliditas
Calliditas Therapeutics is a biopharma company headquartered in Stockholm, Sweden, focused on identifying, developing, and commercializing novel treatments in orphan indications with significant unmet medical needs. Visit Calliditas.com for further information.

About Asahi Kasei
The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 50,000 employees worldwide, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Healthcare, Homes, and Material. Its Healthcare operations include devices and systems for acute critical care, and manufacture of biotherapeutics, as well as pharmaceuticals. For further information, please visit asahi-kasei.com.

SOURCE Asahi Kasei Corporation