Kiniksa preps BLA as Regeneron drug cruises to a PhIII win — shares soar
Kiniksa made a modest $5 million cash bet on Regeneron’s Arcalyst (rilonacept) back in 2017. The startup forged a pact to use the drug, which targets IL-1α and IL-1β, and see how it works against recurrent pericarditis, agreeing to split any profits to come while putting another $27 million in milestones up for grabs.
And the wager paid off handsomely today, as the biotech’s stock surged on their report of a Phase III success that sets up a near-term FDA application. The drug has already won the FDA’s breakthrough drug designation here, heightening expectations of a regulatory success.
Their stock $KNSA jumped 31% in early morning trading Monday.
Researchers at the company say the patient arm recorded a 96% reduction in the rate of recurrence compared to the placebo arm, and were unable to calculate the time to pericarditis recurrence for rilonacept recipients “due to the low number of recurrences in the rilonacept treatment arm.” Noted the biotech:
• 81% of rilonacept recipients maintained clinical response at Week 16 of the randomized withdrawal period, compared to 20% of placebo recipients (p=0.0002). Consistent results were observed at Week 8 and Week 24 and were also highly statistically significant (p<0.0001 and p=0.0022, respectively).
• The proportion of rilonacept recipients with absent or minimal pericarditis symptoms at Week 16 of the randomized withdrawal period was 81% compared to 25% for placebo recipients (p=0.0006). Consistent results were observed at Week 8 and Week 24 and were also highly statistically significant (p<0.0001 and p=0.0002, respectively).
“We believe that, by treating and preventing disease recurrence, rilonacept has the potential to be a transformational therapeutic advancement in the treatment of patients with recurrent pericarditis and to become the first FDA-approved therapy for this debilitating autoinflammatory disease,” noted Kiniksa CMO John Paolini.
Social: Sanj Patel, Kiniksa CEO (Kiniksa via YouTube)