Shares of
CinCor Pharma, Inc
.
CINC
plunged 46.81% on Nov 28, after the company announced disappointing data from the phase II study, HALO, evaluating its lead candidate baxdrostat for hypertension.
Baxdrostat is a once-daily, potentially first-in-class, highly selective aldosterone synthase inhibitor.
The study was a phase II randomized, double-blind, placebo-controlled, multicenter, parallel-group clinical study designed to assess the safety and efficacy of baxdrostat in subjects taking up to two antihypertensive agents at their maximally tolerated dosages. The study evaluated three active doses of baxdrostat (0.5 mg, 1.0 mg, and 2.0 mg) compared to a placebo control in 249 patients randomized across all four dosing cohorts, with 249 patients completing it. The primary endpoint of the trial was the change in systolic blood pressure (SBP) after eight weeks of treatment.
The study’s primary endpoint, evaluating change from baseline in mean seated SBP, failed to achieve statistical significance.
Nevertheless, a pre-specified subgroup analysis of non-Hispanic patients, representing approximately 81-89% of the hypertension population in the United States, demonstrated a placebo-adjusted reduction in SBP of 12.6 mmHg at the 2 mg dose.
Post these eight weeks, the background antihypertensive therapy was discontinued. Patients only took baxdrostat at the 2 mg dose for four additional weeks in part 2 of the trial to characterize monotherapy responses and to enable long-term safety assessments of the drug in the ongoing 52-week open-label extension study that follows the HALO trial, which is expected to be completed in the second half of 2023.
Shares of CinCor have lost 10.6% so far this year compared with the
industry
’s decline of 19.9%.
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In August 2022, CinCor reported positive top-line data from the phase II BrigHtn trial evaluating baxdrostat for patients with treatment-resistant hypertension (rHTN). BrigHtn successfully met the primary endpoint, delivering a 20.3 mmHg absolute reduction in SBP or an 11 mmHg SBP decline on a placebo-adjusted basis, at the 2 mg dose.
The company targets a potential NDA submission of baxdrostat in 2025.
HALO in combination with BrigHtn determines the dose and study populations anticipated to be recruited into phase III trials.
The company continues to expect to meet with the FDA in January 2023 at an end-of-phase II meeting to discuss the phase III program plans. CinCor expects to initiate pivotal phase III studies in the first half of 2023, post the meeting.
Meanwhile, the Spark-PA open-label trial is evaluating the safety and efficacy of baxdrostat in patients with primary aldosteronism (PA). Top-line data from this study is expected in the second half of 2023.
CinCor currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include
Biogen
BIIB
,
Gilead
GILD
and
Solid Biosciences
SLDB
. All three carry a Zacks Rank #2 (Buy). You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
Over the past 30 days, earnings estimates for Biogen have increased by 30 cents to $16.98. Biogen also surpassed estimates in three of the trailing four quarters, with the average being 7.02%.
Over the past 30 days, earnings estimates for Gilead have increased by 55 cents to $7.09. Gilead also surpassed estimates in three of the trailing four quarters, with the average being 0.35%.
Over the past 30 days, loss estimates for Solid Biosciences have narrowed to $8.04 from $10.15. SLDB missed estimates in three of the trailing four quarters, with the average being -4.15%.
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