An experimental psoriasis drug developed by biotechnology company Dice Therapeutics showed signs of effectiveness in a Phase 1 trial, results that sent the company’s shares soaring more than 60% on Tuesday morning.
While early and from a very small study, the data indicated the pill, dubbed DC-806, could significantly shrink skin lesions at the highest dose tested and may compare favorably with other marketed psoriasis treatments. Dice shares surged past $40 apiece, to more than double the $17 per share price they debuted at 13 months ago.
The results come from a three-part Phase 1 trial meant to first assess safety in healthy volunteers and find the best dose to advance into further testing. The last stage of the study tested two different doses of DC-806 in psoriasis patients, looking for early signs of effectiveness.
The higher of the two doses, 800 milligrams taken twice daily, resulted in a 44% mean reduction in the score of a measure of symptoms called PASI in the seven patients who completed the 28-week treatment. The 10 placebo recipients who finished the study, by comparison, had an average 13% reduction in PASI scores, Dice said. While the company didn’t enroll enough patients to calculate whether the results were statistically significant, an “exploratory” analysis designed to study patterns in the data suggested it might be, the company said.
A smaller dose of 200 milligrams twice daily was less potent, reducing the PASI score by 15%.
None of the patients exposed to the drug in the Phase 1 trial experienced a severe adverse event. Headaches and nausea were the most common side effect reported.
DC-806 blocks an immune system regulating protein called interleukin-17. That protein is well known to drug developers. IL-17 is the target of the injectable biologics Cosentyx from Novartis and Taltz from Eli Lilly, while the related IL-17RA is the target of Bausch Health’s Siliq. Dice aims to show its drug can match that potency, though as a pill, its drug has marketed competitors in Amgen’s Otezla and Bristol Myers Squibb’s Sotyktu.
Dice’s investor presentation suggested that the reduction in PASI score seen with the 800 milligram dose is on par with the 36% to 37% seen with Otezla and the 40% to 43% reduction observed in the testing of Sotyktu.
“While we think there are some valid nitpicks with the data — small N, absolute PASI reductions could have been larger, low dose didn't separate — we think that taken together, the data are about as good as you could expect from a small [proof-of-concept] study,” wrote Stifel analyst Alex Thompson, in a research note.
Dice plans to advance the drug into mid-stage testing in the first half of 2023. In the meantime, however, a pipeline of oral IL-17-blocking drugs is also emerging. Leo Pharma initiated a Phase 1 psoriasis trial, and Sanofi is working on a preclinical project with C4X Discovery Holdings. Eli Lilly, meanwhile, reportedly sidelined an oral IL-17 program because of liver toxicity.