Calliditas Announces Positive NefIgArd Open Label Extension Results
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The Open Label Extension (OLE) results for the NefIgArd study from Calliditas offer a continuation of data that is essential for understanding the long-term efficacy and safety of Nefecon in patients with IgA Nephropathy (IgAN). IgAN, an autoimmune kidney disease leading to end-stage renal disease, has few treatment options, making these results noteworthy for stakeholders. From an investor standpoint, the consistency in treatment response reinforces the drug's potential market longevity and could signal future revenue stability for Calliditas.
Considering the chronic nature of IgAN and the limited treatment landscape, the ability of Nefecon to maintain efficacy over repeated treatment cycles could position it as a preferred treatment option, potentially leading to increased market share. However, it is important to monitor the long-term safety profile, as chronic treatments can pose cumulative side-effect risks. Investors should watch for any changes in this profile that might affect drug adoption rates.
Calliditas' announcement regarding the OLE study results adds a layer of confidence in the financial projection for Nefecon. With FDA approval already secured, the positive OLE outcomes may facilitate off-label insurance approvals and expand the eligible treatment population. The financial implications of broadened market access can lead to an uptick in revenue in subsequent quarters.
Investors should note, however, that these results might already be partially priced into the stock, as FDA approval often accounts for anticipated successful post-market studies. What remains critical is capturing market share and ensuring insurance coverage to realize the sales potential highlighted by these clinical results.
NefIgArd was a global, Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of Nefecon 16 mg once daily vs placebo in adult patients with primary IgAN as an addition to optimized RASi therapy. Patients were randomized 1:1 to receive 16 mg/day of Nefecon or matching placebo for 9 months, followed by a 15-month observational follow-up period without the study drug. The NefIgArd study achieved both its primary and key secondary endpoints and was the basis for full approval by the FDA in December 2023. The full data set was published in The Lancet.
The OLE study was designed to provide 9 months of treatment with Nefecon for all patients who completed the NefIgArd study and who at that time had > 1g/g of proteinuria over 24h and > 30 ml/min of eGFR. All enrolled OLE patients continued on optimized RAS inhibitor therapy (ACEs and/or ARBs) and were treated for 9 months with Nefecon 16mg per day, with a follow-up visit three months after completion of treatment. Primary assessment was based on UPCR and eGFR at 9 months. A total of 119 patients were enrolled, of whom 45 had previously had active treatment.
Topline data from the OLE study showed that the treatment response was consistent with the NefIgArd study's findings regarding the endpoints of UPCR and eGFR at nine months across all patients, irrespective of whether they had previously been treated with Nefecon or with placebo. The safety data after 9 months of treatment or retreatment with Nefecon in patients who completed the NefIgArd study were consistent with previously reported safety data.
"It is exciting to see these results on both proteinuria reduction and eGFR stabilization at 9 months across all patients irrespective of previous treatment regimen in the Phase 3 trial,", said CEO Renée Aguiar-Lucander. "These topline results support the study thesis that the response to retreatment with Nefecon was unaffected by previous treatment cycles. We look forward to presenting data at the upcoming ERA EDTA symposium."
For further information, please contact:
Åsa Hillsten, Head of IR & Sustainability, 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 24 April 2024 at 08:30 a.m. CET.
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SOURCE Calliditas Therapeutics
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