Nat Charoensook

Nat Charoensook, on for Thomas Smith of Leerink Partners, asked what the amylin agonist program would need to demonstrate in its Phase I trial, particularly relative to VK2735, to justify continued development.

Answer

President & CEO Brian Lian stated that the goal for the Phase I amylin study is to see an impact on body weight and to understand the tolerability profile. He noted that the industry has matured beyond focusing solely on 28-day weight loss data, and the decision to proceed will be based on the overall trajectory, safety, and tolerability.

Nathanael Charoensook, on for Tom Smith, asked about the expected usage split among the three VYVGART product presentations (IV, Hytrulo, PFS) and how the payer mix is expected to evolve.

Answer

Chief Operating Officer Karen Massey stated that the majority of new patient growth is already coming from Hytrulo and expects this to accelerate with the PFS launch, which is seen as a 'game changer'. Chief Financial Officer Karl Gubitz added that the current payer mix is roughly 50-50 between commercial and Medicare, and he does not expect that to change significantly.

Inquired about the expectations for the ENSURE study's interim futility analysis, the criteria for continuing development in RMS, and details for the planned Phase 2 celiac disease trial, including gating factors, trial size, and potential endpoints.

Answer

The ENSURE interim analysis is strictly for futility and will not include biomarker data; it may result in a sample size adjustment. The Phase 2 celiac disease study is being designed with potential for other GI indications, but it is not yet funded and the company is seeking partnerships.