Calliditas Therapeutics to Present Data at ERA 2024 in Stockholm, May 23-26

Calliditas Therapeutics AB has announced its participation in the 61st European Renal Association (ERA) Congress, to be held in Stockholm, Sweden from May 23 to May 26, 2024. The company is set to present new data and host a symposium during the event. The presentations will focus on the efficacy of Nefecon (also known as TARPEYO®), a delayed-release budesonide capsule, in treating primary immunoglobulin A nephropathy (IgAN) and discuss the real-world challenges of using systemic glucocorticoids (SGCs) for this condition.

Richard Philipson, the Chief Medical Officer of Calliditas, expressed enthusiasm about participating in the ERA congress. He highlighted the significance of being in Stockholm, where the company is headquartered, to showcase their latest research on a treatment specifically designed for IgA nephropathy. Philipson emphasized the importance of addressing the unmet needs in this rare disease.

One of the key presentations is titled "Matching-adjusted indirect comparison of eGFR in patients with immunoglobulin A nephropathy treated with Nefecon (TRF budesonide) or sparsentan." This oral poster presentation will take place on May 25 from 3:15 to 4:30 PM CET in Focused Oral Room 3. Another notable presentation is "Real-world challenges associated with the use of systemic glucocorticoids in a US IgAN cohort," scheduled for May 26 from 8:54 to 9:06 AM CET in room A5.

The symposium, titled "Clinical Markers in IgA Nephropathy: Is All Proteinuria the Same?" is set for May 25 from 10:15 to 11:15 AM in Room A2+A3. The session will be moderated by Professor Jonathan Barratt from Leicester University and will feature a panel including Dr. Shikha Wadhwani from Northwestern University and Dr. Richard Lafayette from Stanford Healthcare.

TARPEYO is specifically indicated to reduce kidney function loss in adults with primary IgA nephropathy who are at risk of disease progression. However, it is contraindicated for patients with hypersensitivity to budesonide or any of the components of TARPEYO. Serious hypersensitivity reactions, including anaphylaxis, have been reported with other budesonide formulations.

Chronic use of corticosteroids like TARPEYO can lead to hypercorticism and adrenal suppression. Systemic effects are possible, especially in patients with moderate to severe hepatic impairment, as they may experience increased systemic exposure to budesonide. Patients using corticosteroids are more susceptible to infections like chickenpox and measles, which can be severe or even fatal. Corticosteroid therapy should be avoided in patients with active or latent infections, untreated bacterial or fungal infections, and ocular herpes simplex.

Common adverse reactions observed in clinical studies of TARPEYO (affecting 5% or more of patients) include peripheral edema, hypertension, muscle spasms, acne, headache, upper respiratory tract infection, face edema, weight gain, dyspepsia, dermatitis, arthralgia, and increased white blood cell count.

Budesonide, the active ingredient in TARPEYO, is metabolized by the enzyme CYP3A4. Therefore, it is advised to avoid using TARPEYO with potent CYP3A4 inhibitors like ketoconazole and ritonavir, and grapefruit juice, which can inhibit CYP3A4 activity and increase budesonide's systemic exposure.

Regarding usage during pregnancy, available data from case series, epidemiological studies, and reviews have not identified a significant risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes associated with budesonide. However, infants exposed to corticosteroids in utero, including budesonide, may be at risk for hypoadrenalism.

TARPEYO is an oral, delayed-release formulation of budesonide, designed to reach the ileum intact. It targets mucosal B-cells in the ileum that produce galactose-deficient IgA1 antibodies, which are implicated in IgA nephropathy. IgAN is a rare, chronic autoimmune disease that primarily affects the kidneys, leading to progressive kidney damage and potentially resulting in end-stage renal disease. It typically manifests between the late teens and late 30s.

Calliditas' participation in the ERA Congress underscores its ongoing commitment to addressing the needs of patients with IgAN through innovative treatments and research. The presentations and symposium will provide valuable insights into the efficacy and challenges of current therapies for this condition.