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Novartis (NVS) Posts Positive Data on Kidney Disease Candidate

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Novartis AG (NVS - Free Report) announced positive data from a mid-stage study on iptacopan (LNP023), a first-in-class, oral, targeted factor B inhibitor, at the 58th ERA-EDTA Congress.

Patients (n=112) with immunoglobulin nephropathy (IgAN) were randomized to placebo or different doses of iptacopan in the phase II study (NCT03373461).

Iptacopan met its primary endpoint for rare kidney disease IgA nephropathy (IgAN). The candidate reduced protein in the urine (proteinuria), an increasingly recognized surrogate marker correlating with progression to kidney failure, and showed immense promise in stabilizing kidney function among patients with IgAN.  

The primary endpoint was met with a statistically significant dose response effect on reduction in proteinuria with iptacopanas compared to placebo at 90-day regimen. Iptacopan also showed a trend toward stabilization of kidney function.

It is significant to note here that IgAN currently does not have approved treatments.

Hence, the efficacy data, seen after 90 days of treatment, along with the safety profile raises hope that inhibition of the alternative complement pathway with iptacopan could be an effective way to delay the IgAN disease progression. This, in turn, also increases the probability of a likely approval if the subsequent data is found favorable.

A phase III study APPLAUSE is already underway.

Iptacopan is the most advanced asset in Novartis’ nephrology pipeline and targets the alternative complement pathway, a key driver of complement-driven renal diseases (CDRDs), which include IgAN and C3 glomerulopathy (C3G), and the blood disorder paroxysmal nocturnal hemoglobinuria (PNH).

The candidate received an orphan drug designation in Europe for IgAN, apart from orphan drug designations from the FDA and EMA for C3G and PNH, an FDA Breakthrough Therapy Designation for PNH and an EMA PRIME designation for C3G.

The company also announced results from the phase III RATIONALE 302 study at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Results showed that the investigational anti-PD-1 immune checkpoint inhibitor tislelizumab improved overall survival (OS) compared to chemotherapy.

Shares of Novartis have lost 4.9% so far this year against the industry’s growth of 5.5%.

 

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In April 2021, Calliditas Therapeutics AB (CALT - Free Report) announced that the FDA accepted its submission and granted a Priority Review to the New Drug Application (NDA) for Nefecon, a down regulator of IgA1 for the treatment of IgA nephropathy (IgAN.)

Omeros (OMER - Free Report) is also evaluating narsoplimab for IgAN.

Novartis currently carries a Zacks Rank #4 (Sell).

A better-ranked stock in the large cap pharma space is Bayer AG (BAYRY - Free Report) , which currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Bayer’s earnings estimates have been revised 4% upward for 2021 and 5.8% for 2022 over the past 30 days.

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