Calliditas Presents Additional Data Analyses from the NefIgArd Phase 3 trial at the American Society of Nephrology (ASN) Kidney Week 2023

Oral Presentation Analyses Oral Presentation Analyses NefIgArd Phase 3 Trial full analysis The Phase 3 double-blind, randomized NefIgArd study evaluated the impact of Nefecon, a novel targeted-release formulation of budesonide, vs placebo on eGFR in adults with IgAN. The 2-year study period consisted of nine months of treatment with Nefecon (16 mg/day) or placebo, followed by a 15-month follow-up period off the study drug. The full analysis of the 364 patients randomized 1:1 to...

Oral Presentation Analyses

NefIgArd Phase 3 Trial full analysis

The Phase 3 double-blind, randomized NefIgArd study evaluated the impact of Nefecon, a novel targeted-release formulation of budesonide, vs placebo on eGFR in adults with IgAN. The 2-year study period consisted of nine months of treatment with Nefecon (16 mg/day) or placebo, followed by a 15-month follow-up period off the study drug. The full analysis of the 364 patients randomized 1:1 to Nefecon or placebo showed:

Late-Breaking Poster Presentation Analyses

NefIgArd Phase 3 trial population sub-analysis

The 2-year NefIgArd trial included 62 patients with IgAN from mainland China (n=32 in Nefecon arm, n=30 in the placebo arm), with similar baseline characteristics as the global study population. In these patients, Nefecon treatment for 9 months resulted in:

Poster Presentations Analyses

Additional analyses were conducted from Part A of the Phase 3 NefIgArd trial(n=160)

Additional analysis from the full Phase 3 NefIgArd trial

Setanaxib

The potential of setanaxib, a novel dual NOX inhibitor to modulate renal function and fibrosis was evaluated in a mouse model of Alport syndrome, a rare genetic disease characterized by fibrosis and progressive kidney damage. Setanaxib was evaluated alone or in combination with standard of care ramipril, an ACE inhibitor.

All presentations are available on the Presentations and Publications page on the Calliditas' corporate website.

CONTACT:

For further information, please contact:

Åsa Hillsten, Head of Investor Relations & Sustanaibility, Calliditas

Tel.: +46 76 403 35 43, email: asa.hillsten@calliditas.com

The information was sent for publication, through the agency of the contact persons set out above, on November 6, 2023 at 20:30 p.m. CET.

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