Swedish pharmaceutical company Calliditas Therapeutics has initiated the Phase 3 NEFIGARD trial to evaluate its lead drug candidate, Nefecon, for treating IgA nephropathy (IgAN), commonly known as Berger’s disease.

The NEFIGARD trial marks a significant step for Calliditas Therapeutics as it begins enrolling patients for a late-stage study designed to assess the effectiveness of Nefecon compared to a placebo in reducing proteinuria—a key indicator of kidney function impairment in IgA nephropathy patients. This chronic autoimmune disease occurs when immunoglobulin A (IgA) antibodies deposit in the kidneys, leading to inflammation and potentially damaging kidney function over time.

Phase 3 NEFIGARD Trial Details

Calliditas Therapeutics has commenced the trial with the enrollment of its first patient. The NEFIGARD study aims to include approximately 450 participants who will receive either the investigational drug Nefecon or a placebo in a nine-month, once-daily oral regimen. The trial is set to take place at nearly 150 clinical sites across 19 countries.

Renee Aguiar-Lucander, CEO of Calliditas Therapeutics, expressed enthusiasm about the trial’s initiation: “As outlined at our IPO, we have a clear strategy to maximize the potential of Nefecon as a disease-modifying treatment for patients suffering from this chronic autoimmune disease. I am very pleased to announce the study start, which is a critical step as we accelerate the development of Nefecon through Phase 3 clinical trials.”

Background and Previous Success

The NEFIGARD trial follows promising results from a Phase 2b study of Nefecon, which demonstrated potential benefits for IgA nephropathy patients. Jens Kristensen, Chief Medical Officer of Calliditas Therapeutics, commented, “We are pleased to announce the randomization of the first patient in this important Phase 3 study. We have previously shown good efficacy and safety of Nefecon in the comprehensive NEFIGAN study, which as of today is the only successful, placebo-controlled Phase 2b study in this indication. We expect to see similar results in reducing proteinuria and stabilizing kidney function, coupled with the benign safety profile observed so far.”

The results from the initial 200 patients are anticipated to guide the company’s decision on seeking regulatory approval. Top-line data from the NEFIGARD trial is expected to be released in the second half of 2024.

Next Steps and Expectations

Should the Phase 3 trial yield positive results, Calliditas Therapeutics plans to pursue regulatory approval for Nefecon. This trial represents a crucial milestone in the company’s efforts to address the unmet needs of patients with IgA nephropathy.

  Calliditas Therapeutics, IgA nephropathy, Jens Kristensen, Nefecon, Proteinuria, Renee Aguiar-Lucander, Sweden