- An experimental drug from Waltham, Mass.-based biotechnology company CinCor Pharma failed a Phase 2 trial in patients with stubbornly high blood pressure known as uncontrolled hypertension.
- CinCor on Monday said the drug didn’t meaningfully lower blood pressure compared to a placebo, missing the study’s main goal. The drug did succeed in a previous Phase 2 trial in a different group of patients with high blood pressure, though, and CinCor still intends to bring the medicine into late-stage testing next year.
- Prior to the negative results, CinCor had been one of the best performing companies among biotech’s 2022 IPO class, with shares climbing more than 66% since debuting at $16 apiece in January. Most of those gains were erased on Monday, though as shares fell more than 47%, to about $14.
While myriad medicines exist to lower blood pressure, there are fewer options for people whose numbers remain too high even after treatment. CinCor is one of several companies developing medicines for those individuals, and its drug has met its goal in a Phase 2 study among patients who didn’t respond to at least three blood pressure medications.
The CinCor study results announced Monday looked at patients whose blood pressure was “uncontrolled” despite taking up to two medications. The trial results were anticipated by investors, as they were meant to help “inform the path forward and market opportunity” for the drug, wrote Jefferies analyst Dennis Ding in a note to clients.
Investors instead got a surprise, as what Ding described as a “huge placebo effect” caused baxdrostat to miss the main study goal.
In a press release, the company pointed to positive results from a pre-specified subgroup of 116 non-Hispanic patients, who made up 47% of the trial’s participants. In that analysis, those patients saw a nominal statistically significant reduction in seated systolic blood pressure.
The drug’s safety profile was consistent with what was seen in CinCor’s other Phase 2 trial, the results of which were published in the The New England Journal of Medicine earlier this month.
“We are pleased [the study] has achieved our prospective goal of better understanding which patients respond best to baxdrostat, as well as further confirming baxdrostat’s safety profile and tolerability,” Marc de Garidel, CinCor’s CEO, said in a statement.
The company plans to move forward with Phase 3 trials next year, and said it would be “on track” for an approval submission in 2025 if those succeed.
Still, the findings raised doubts among analysts. Ding, for instance, wrote that CinCor’s prospects are “now murkier” than they were before. And Evercore ISI analysts Umer Raffat and Michael DiFiore noted the company’s explanations for the study’s failure — from a high placebo response to patient adherence — are “at odds” with its prior results.
“Overall, this trial is impossible to interpret,” Raffat and DiFiore wrote.
At least one competitor has gotten further with a drug for treatment-resistant hypertension. Idorsia, a Swiss pharmaceutical firm partnered with Johnson & Johnson, is expected to file for regulatory approval for its drug aprocitentan by the end of 2022 after reporting positive Phase 3 results in May.