VKTX cc on VK2735 was very well received by the analyst community. Most seemed amazed by the tolerability/safety results. Here are some initial thoughts:
Outstanding tolerability. "Almost no side-effects”. No clinically significant difference between study participants and placebo
2 subjects had diarrhea in placebo compared to 1 in the 2nd highest dose of 20 mg.
placebo effect was high at 2.1% weight loss. Possible reason was the small numbers (n=10 for placebo) and 2 subjects had diarrhea.
2 total discontinuations- one for family reasons- other was for abdominal reasons.
Noted that effect was durable 6 days after study dosing stopped while placebo group gained 0.5% weight. Had this been included the placebo adjusted weight loss would have been 3.8%. Also noted that other drugs in testing had rebounds immediately after dosage stopped.
PK was such that they saw slow accumulation- seems like VK2735 is almost "self-titrating". Brian Lian when asked if there was a need to titrate said "doesn't look like it but we will continue to do titrate"
Found it interesting that one analyst (Justin Zelin at BTIG) asked if oral was safer than Subq version.
Viking did not disclose what the "special formulation" was for an oral peptide that made it work.
Adding another cohort at higher dose- likely to see increased weight loss. Overall study numbers may change slightly. Adding a few more placebo at the same time.
Question about manufacturing a peptide and whether there was a point at where it didn't make sense to dose scale- answer was "we aren't stopping and we are spending a lot of time on manufacturing- currently have plenty of material for registrational studies". Brian Lian did not seem deterred at all by this question.
Regarding food, participants were asked to dose in the am after waking and not to consume food for 30 mins.
Just got data so no Metabolic data available yet (e.g. for lipids, glucose etc.). Will likely release metabolic data towards end of the summer.
I think this was a home run. Placebo adjusted Weight loss close to 4% at 28 days, clear indication of dose response, incredibly good safety profile.
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