Patrick Burnett shares about the secondary endpoints and safety data of the CAMP 1 & 2 clinical trials.
Aside from meeting the primary endpoint at week 12, the CAMP 1 and 2 trials met several secondary endpoints. Both studies met the complete clearance endpoint at weeks 9 and 6, and CAMP 1 met this at week 3 as well.
“The primary endpoint was week 12—we also looked at complete clearance at weeks 9, 6, and 3, and all of those met the p-value of less than .05 with the exception of the week 3 endpoint in the CAMP 2 trial,” said Patrick Burnett, MD, PhD, Chief Medical Officer of Verrica Pharmaceuticals and an investigator on the trials.
Burnett spoke with MD Magazine® about the data at the 2019 Annual Meeting of the American Academy of Dermatology (AAD) in Washington, DC. He added that there were no serious adverse events with VP-102 treatment, and the adverse events that did occur were expected based on the treatment’s mechanism of action.
The presentation, “CAMP-1 (Cantharidin Application in Molluscum Patients) and CAMP-2: Phase 3, Randomized, Double-Blind, Placebo-Controlled, Pivotal Studies Investigating VP-102,” was given at a late-breaking session at the AAD Annual Meeting on Saturday, March 2, 2019. Here is part 1 of his interview.
MD Mag: What secondary endpoints did the CAMP studies meet?
Burnett: Yeah, so, there's a couple other end points that I think are really important. The secondary endpoints that we looked at were that complete clearance end point, but at earlier treatment periods. So, I mentioned that the primary endpoint was week 12—we also looked at complete clearance at weeks 9, 6, and 3, and all of those met the p-value of less than .05 with the exception of the week 3 endpoint in the CAMP 2 trial. In CAMP 2 we were numerically better than placebo for complete clearance, but it had a p-value that wasn't less than .05. So, what that showed to me is that even early on in treatment patients are getting a clinical response that they can see and they're showing that they're going to see a difference in their molluscum contagiosum even at these earlier time points.
What adverse effects did you see in patients treated with VP-102?
In both CAMP 1 and CAMP 2, we didn't have any patients on VP-102 who had a serious adverse event. The patients who had adverse events were mostly application site reactions, and this is related to the mechanism of action of the main ingredient in VP-102. So, the main ingredient is cantharidin which is a vesicant, which means that it causes the blister to form and that lifts up and actually removes the lesion from the skin and so based on that, you would anticipate—and we had planned—for patients to have local skin reactions that were appropriate for that mechanism of action. So, things like blister formation, discoloration of the skin, a little bit of redness, and things like that.