Dive Brief:
- An experimental pill from Johnson & Johnson and biotechnology company Protagonist Therapeutics helped relieve the symptoms of patients with moderate-to-severe plaque psoriasis in a Phase 2 trial, findings that support bringing the medicine into late-stage testing, the companies said Tuesday.
- After four months, a greater proportion of patients who received the drug instead of a placebo achieved at least a 75% reduction on a measure known as PASI which assesses the size and severity of skin lesions, hitting the study’s main goal. More drug recipients achieved 90% or total skin clearances as well, J&J said.
- Treatment was “generally well tolerated,” with comparable rates of side effects reported among those who received J&J’s drug or placebo. The most common adverse events were infections and infestations, and there was no evidence that they increased at higher dose levels. J&J is planning a Phase 3 trial in psoriasis and a mid-stage study in ulcerative colitis.
Dive Insight:
J&J’s disclosure is the latest salvo in a competitive race to use pills, rather than injectable medicines, to treat autoimmune conditions like psoriasis. Drugmakers are hoping these treatments can compare favorably with marketed injectable biologic medicines, but with the convenience of a pill.
A number of companies are working on oral treatments that block a protein called TYK2, for instance. The Food and Drug Administration approved the first, a Bristol Myers Squibb medicine called Sotyktu, for psoriasis last year. Several other developers, like Takeda and Ventyx Biosciences, are following with similar medicines.
Others are focused on different targets. Eli Lilly acquired Dice Therapeutics last month for drugs aimed at a immune system-regulating protein named IL-17. And J&J’s medicine, known as JNJ-2113, homes in on an inflammatory protein, IL-23, that its marketed injectables Tremfya and Stelara target.
The drug emerged from a 2017 collaboration between J&J and Protagonist. J&J executives earlier this year said they expected “biologic-like efficacy” from the drug’s approach, heightening anticipation for the results revealed on Tuesday.
Those findings come from a Phase 2b trial that enrolled 255 participants and randomized them to receive either a placebo or one of five different regimens of J&J’s drug. Patients were treated for 16 weeks.
The results were better at higher doses. About 58% of those who received a once-daily dose of 50 mg had at least 75% reduction in PASI scores, versus about 9% of placebo recipients. More than half of them had a 90% improvement, and about a quarter experienced a 100% reduction.
At a once-daily, 100 mg dose, 65% of drug recipients had PASI score reductions of at least 75%. J&J said 90% reductions were observed in 47% of patients in that group, and roughly 23% of them had total skin clearance. (The company tested twice-daily regimens as well, but development partner Protagonist has said J&J will likely advance a once-a-day regimen).
The overall numbers approach or exceed what was observed with Tremfya and are “setting new efficacy/safety bars” for oral therapies in psoriasis, wrote Jefferies analyst Roger Song in a note to clients.
Though it’s difficult to compare drugs across trials, the results also look favorable to mid-stage data that Takeda presented earlier this year, added another Jefferies analyst, Stephen Barker. Yet, shares of Protagonist fell more than 30% when summary results were first disclosed on Monday, as the “market may have had higher expectations,” he wrote.
The findings still give companies like Ventyx and Alumis, which are developing newer TYK2 drugs, “a shot at superior oral efficacy,” wrote Stifel analyst Alex Thompson.
Ventyx shares climbed more than 20% between Monday and early Wednesday.