The phase 2 Believe-PV study observed few adverse events in patients with pemphigus vulgaris.
Investigators of the Believe-PV trial reported few adverse events and just one serious infection among patients with pemphigus vulgaris receiving the investigational treatment PRN1008.
Dedee Murrell, MD, professor and chair of dermatology at the University of New South Wales, Kensington, Australia, spoke with MD Magazine® about the data at the 2019 Annual Meeting of the American Academy of Dermatology (AAD) in Washington, DC.
The phase 2 Believe-PV study reported a positive safety profile in patients with pemphigus vulgaris, however, Murrell noted that the study was not placebo-controlled. A placebo-controlled phase 3 trial of the investigational treatment, PRN1008, is currently recruiting participants.
Murrell’s presentation was given at a late-breaking session at the AAD Annual Meeting on Saturday, March 2, 2019. Here is part 1 of her interview.
MD Mag: What were the safety outcomes for the Believe-PV trial?
Murrell: The trial was non-placebo controlled—we’re starting a phase 3 trial—so, when you're assessing side effects, you really need to look at a placebo-controlled trial to see what the rates are between an active drug and a placebo. So, in this study it was just the tablet alone for 3 months. There were a few minor things, like headache, a bit of nausea. They all continued on the drug and those side effects disappeared, so they could have just been a fluke that they happened.
There was one serious infection. It was in one of my patients who’d had 9 years on steroids for his pemphigus. He’d become a diabetic—he'd been getting recurrent infections in his legs from mile degrees of cellulitis, which his local doctor managed with topical antibiotics. And over the weekend in the middle of the trial—he'd been on 26 days—he noticed the red area on his leg wasn't getting better with the topical antibiotic and he went to the local hospital. He got admitted over the weekend and they put him on IV antibiotics and rang me on Monday. And anyway by then he was better and discharged from the hospital and went back on the trial drug finished the trial and was fine.