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STOCKHOLM, Nov. 6, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas"), today announced data presentations highlighting additional analyses from the Phase 3 NefIgArd study with Nefecon in adults with primary IgA nephropathy (IgAN), as well as pre-clinical data on the treatment of Alport syndrome with setanaxib, a novel NOX inhibitor, presented at the American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA on November 1-5, 2023.
"The additional analyses of data from the NeflgArd Phase 3 trial that we and our scientific collaborators presented at ASN Kidney Week showcased our commitment to advancing the science in understanding IgA nephropathy and to shaping a better future for patients with rare diseases," said Richard Philipson, Chief Medical Officer at Calliditas.
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.
The following files are available for download:
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