VKTX – Here are my notes/impressions from yesterday’s Viking cc on the VK2735 Venture results:
All analysts on the call were effusive in praise for both efficacy and tolerability.
Almost all AE’s were mild or moderate and noted to be predominantly occurring in the first week while resolving very quickly. Some discussion of clinicians been overly attuned to GI events for the drug class. No elevated liver enzyme events. General reading of the tea leaves indicated extremely good tolerability for VK2735 that should translate to a major competitive advantage.
Some discussion of how discontinuations were reported. As I heard it they said “Discontinued treatment early” meant the participant missed at most 2 doses but stayed in the study while “Discontinued study early” meant the participant didn’t finish the study. Note that only 5 participants in total did not complete the study and that study discontinuations in all cohorts were comparable to placebo.
PK half life not yet available but data from phase 1 plus efficacy shown in Venture is thought to support once monthly dosing for VK2735
Efficacy slopes at all doses did not show any signs of plateauing. One of the higher doses was thought to be showing some acceleration although that could have been from weekly variability.
6-week follow-up data not yet known. (In phase 1 effect was durable) Follow-up data plus lipids due in 2nd quarter (non-committal as to when/how this info would be released.
Phase 2b is next, obesity the focus followed by Mash as important indications for VK2735. Type C meeting with FDA likely mid-year.
Patent/IP protection extends beyond 2040.
“Open door” policy remains for Business Development. (For sale sign still out there but partnering a real possibility)
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