Liam Hiester

Liam Hiester of Piper Sandler Companies inquired about the SOTA CROSS trial for sotagliflozin, asking for details on its design, dosing, patient criteria, and the rationale for focusing on non-obstructive hypertrophic cardiomyopathy (nHCM).

Answer

SVP & Chief Medical Officer Dr. Craig Granowitz explained that the NIH-supported trial targets nHCM due to the high unmet need, as approved options only exist for obstructive HCM. He noted the crossover design provides significant statistical power despite a small sample size and that the inclusion criteria are very similar to the larger Phase 3 SONATA HCM trial. Dr. Granowitz emphasized that the SOTA CROSS, SOTA Picardia, and SONATA HCM studies collectively build a comprehensive data package for sotagliflozin's potential benefits.

Liam Hiester of Piper Sandler asked about the current toxicology package for VTX3232, the necessary steps to initiate its Phase II obesity trial, the rate-limiting factors for starting VTX2735 trials in MACE and pericarditis, and the level of partnership interest for VTX002.

Answer

CEO Raju Mohan explained that the current VTX3232 tox package supports 28-day studies, with longer-term coverage expected in H2 2024. He described the initiation of Phase II trials for VTX2735 as part of a standard planning process. Regarding VTX002, he mentioned a productive End-of-Phase-2 meeting with the FDA and confirmed that the company is actively seeking a partner, with updates to follow.