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Expert Interview

Slingshot members are talking to an expert! The topic is:

Analyzing the Pivotal VALIANT Phase 3 Results for Pegcetacoplan in C3G and IC-MPGN from Apellis Pharmaceuticals (APLS)

Ticker(s): APLS

Who's the expert?

Institution: University of Leicester

  • Consultant Nephrologist at University Hospitals of Leicester NHS Trust & Senior Lecturer at University of Leicester.
  • Worked extensively in the area of glomerular diseases, especially IgA nephropathy, and chronic kidney disease.
  • Principal investigator and UK chief investigator on numerous clinical trials in IgAN & CKD.

Interview Questions
Q1.

The VALIANT study reported a statistically significant 68% reduction in proteinuria for pegcetacoplan-treated patients compared to placebo. How meaningful is this level of reduction in delaying disease progression and improving outcomes for C3G and IC-MPGN patients?

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Q2.

The stabilization of eGFR observed in pegcetacoplan-treated patients is a critical marker of kidney function. Could you discuss the implications of this finding for long-term kidney health in C3G and IC-MPGN patients?

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Q3.

With 71% of pegcetacoplan-treated patients achieving zero C3c staining intensity, what does this level of deposit clearance suggest about the treatment’s ability to reduce disease activity and inflammation?

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Q4.

The results were consistent across C3G and IC-MPGN patients, as well as adolescents, adults, and both native and post-transplant kidneys. How significant is this broad applicability for meeting the treatment needs of diverse patient groups?

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Q5.

Given the favorable safety profile demonstrated in VALIANT, how does pegcetacoplan’s safety and tolerability compare to current options, and how critical is this for patients requiring long-term treatment?

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Q6.

Considering the high recurrence rate of disease in post-transplant patients, what does this study indicate about pegcetacoplan’s potential to support transplant longevity and reduce recurrence risk?

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Q7.

With plans to submit regulatory filings in the U.S. and EU in early 2025, what are the main considerations for pegcetacoplan’s approval, especially given the rarity and severity of C3G and IC-MPGN?

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Q8.

The VALIANT study results provide an optimistic outlook, but what are your expectations for the long-term efficacy and durability of pegcetacoplan as patients transition into the open-label phase and the long-term VALE study?

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