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In a statement, the San Diego-based company said its oral, once-daily compound paltusotine achieved the primary and all secondary endpoints of a randomized and placebo-controlled Phase 3 study.
A total of 83% of patients using paltusotine maintained growth-factor levels, versus 4% who had taken the placebo. According to three analysts cited by Reuters, about 70% of patients receiving paltusotine were expected to keep growth-factor levels steady.
Participants who took the drug saw “no severe or serious adverse events,” Crinetics added.
During the study, “biochemically controlled” patients who had been given injections to treat acromegaly — a disorder where the body naturally produces too much growth hormone — were given the oral alternative. A principal investigator who was quoted by the firm noted that the transition to oral treatments from injections was “done seamlessly” and maintained “symptom control.”
“We could not be more excited by the results from [the study], which further reinforce our conviction that, if approved, paltusotine could address patients’ unmet need for a simple, oral, once-daily therapy,” said Crinetics Founder and Chief Executive Scott Struthers.
He added that the business would look to attain regulatory approval for the drug “as quickly as possible” once a separate trial is completed early next year of acromegaly patients who are “treatment-naive” or not currency receiving any medical therapy.
