As if the race to get IL-17 inhibitors to market for inflammatory skin conditions wasn’t hot enough, MoonLake Immunotherapeutics has posted phase 2 data claiming to show its drug can take on all-comers in treating hidradenitis suppurativa (HS).
The Swiss biotech designed the 234-person MIRA trial to see whether its trivalent camelid nanobody, called sonelokimab, could “meet or beat” the competition. To this end, MoonLake deliberately used a primary endpoint of a 75% or more reduction in total abscess and inflammatory nodules by Week 12, as opposed to a 50% or more reduction more commonly used in trials of HS drugs.
By showing that a “significantly greater proportion” of patients taking sonelokimab achieved the 75% reduction endpoint than those on placebo, the company claimed the trial results had set a “new bar” for treating HS.
It seems investors might agree with them, with the company’s stock soaring almost 62% to $41.87 by 10:45 a.m. ET on Monday from a Friday closing price of $25.88.
The 50% reduction maker was one of the trial’s secondary endpoints, and here MoonLake said sonelokimab demonstrated a p-value of less than 0.0001, which the Zurich-based biotech described as a “greater delta than observed for any other molecules.”
Both the 120 mg and 240 mg doses used in the study performed similarly, the biotech said, with the 120 mg dose coming up slightly on top. “The results suggest that, as early as week 12, the Nanobody sonelokimab, relative to placebo, reaches the highest clinical activity among all other therapies tested in similarly stringent pivotal-like trials,” the company said.
The “meet or beat” trial strategy had been an “ambitious goal” for sonelokimab, MoonLake CEO Jorge Santos da Silva, Ph.D, said in the Sunday morning release. “We have achieved our ‘beat’ goal with the positive outcome of the phase 2 MIRA trial. In doing so, we have raised the bar for what can be accomplished for HS and these positive topline data provide us with even greater confidence as we look forward to our next steps and our aspiration to become a leader in the inflammation and immunology space.”
The biotech is also testing sonelokimab, which inhibits both IL-17F and IL-17A, in a phase 2 trial in psoriatic arthritis, which is due to read out in the fourth quarter. It has already completed a midstage trial in psoriasis.
Holding $63.1 million in cash and equivalents as of the end of March, MoonLake isn’t flush with funds by biotech standards, but the company stated last month that “careful financial management” means it should eek this money out into the end of 2024. This “robust” cash position will not only see the biotech through its two phase 2 trials but also fund phase 3 preparations. Having just the one asset to focus on probably doesn’t hurt, either.
Coming just days after Eli Lilly handed over $2.4 billion upfront to acquire Dice Therapeutics, MoonLake’s data are a reminder of why IL-17 is such a hot R&D target at the moment.
In a note published ahead of the data drop, Jefferies analysts said the improved efficacy of IL-17 drugs when compared to Humira—which remains the only FDA-approved biologic for HS—should lead to at least a doubling of treatment duration once these drugs reach the market. Novartis’ Cosentyx, which received European approval for HS earlier this month, has shown “good durability” in phase 3 trials of HS, the analysts noted.
At stake is an HS market that the Jefferies analysts estimated could reach more than $5 billion by 2030.