Viking Therapeutics (VKTX) Stifel 2024 Healthcare Conference summary

Product development and clinical strategy

• Injectable formulation is positioned as the primary therapy for induction of weight loss, with weekly dosing envisioned for 6–9 months or until target weight is reached.

• Transition options include moving to a monthly or oral formulation for maintenance, leveraging the same molecule to minimize new side effects.

• Oral formulation demonstrated over 8% weight reduction from baseline in a 28-day study, with good maintenance of effect and muted rebound after dose reduction.

• Flexibility in dosing regimens is supported, with potential for high-dose induction followed by lower-dose maintenance to optimize supply and patient convenience.

• Tolerability is attributed to gradual absorption and dual GLP-1/GIP mechanism, with GIP activation mitigating GI side effects.

Clinical data highlights and future studies

• VENTURE study update showed durable weight loss, with over 80% maintained seven weeks post-treatment and favorable regression from prediabetic to non-diabetic states.

• Oral formulation studies indicated parallel weight loss curves between continuous and alternate-day dosing, suggesting lower doses may suffice for maintenance.

• Phase 3 planning includes large-scale registration studies (4,500 participants, 52 weeks, 1,500 on placebo), with protocol synopses submitted for obesity and obese diabetic populations.

• Monthly dosing regimens will be explored in separate studies due to statistical complexity, aiming to add these data to the registration package post-phase 3.

• Muscle loss versus fat loss is being evaluated, with animal data showing primary fat loss and a separate oral agent (VK5211) available for muscle gain.

Manufacturing and supply chain considerations

• Manufacturing scale-up is a key focus, with multiple global vendors engaged to ensure future supply of both API and autoinjectors.

• Third-party supply arrangements are targeted for finalization by year-end, prioritizing long-term, multi-ton API suppliers.

• API supply is the immediate priority, with autoinjector lines to follow; Catalent is not a current supplier for autoinjectors.

• Industry-wide supply challenges are acknowledged, but proactive planning is underway to avoid shortages when products launch.