Benzinga | Nov 4, 2021 01:45PM EDT

Novartis' Iptacopan Meets Primary Endpoint Goal In Rare Kidney Disease Trial

* Novartis AG (NYSE:NVS) has announced Phase 2 trial data of iptacopan, a selective factor B inhibitor, in patients with C3 glomerulopathy (C3G).

* In C3G, an overly-active alternative complement pathway causes deposits of C3 protein to build up in blood vessels that filter waste and remove extra fluids from the blood.

* The data were presented at the American Society of Nephrology (ASN) 2021 Annual Meeting.

* The trial met primary endpoints in both patient cohorts.

* Patients were treated with 200mg of iptacopan twice daily for 12 weeks, in addition to background therapy.

* Patients in cohort A (n=16) who have not had a kidney transplant [native C3G]) showed a significant 45% reduction in proteinuria (protein in urine) compared to baseline.

* Patients in cohort B (n=7) whose C3G had returned following a kidney transplant) showed significantly reduced C3 protein deposits compared to baseline.

* Additionally, both cohorts showed sustained and robust inhibition of alternative complement pathway activity and normalization of serum C3 levels over 12 weeks.

* Iptacopan showed a favorable safety and tolerability profile, with no serious adverse events suspected to be related to iptacopan.

* Related Link: Novartis's Iptacopan Aces Mid-Stage Kidney Disease Trial.

* Price Action: NVS shares are down 0.18% at $83.44 during the market session on the last check Thursday.