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I briefly covered CinCor (NASDAQ:CINC) as it IPO-ed last year. CinCor is an under-the-radar company that managed to raise a good deal of money from its IPO. It is backed by big name funds and biotech investors like Sofinnova, General Atlantic, venBio, and 5AM Ventures. Its lead and only asset is CIN-107, a selective aldosterone synthase antagonist licensed from Roche in 2019 for $3mn.
While at Roche, CIN-107 was known as RO6836191. It went through a number of preclinical and early clinical studies. The science behind aldosterone antagonism has been known for more than 70 years. Aldosterone dysregulation has been known to cause a number of diseases, including hypertension. Aldosterone antagonists have been developed for years now, however they suffer from a peculiar problem. Aldosterone synthase is encoded by the CYP11B2 gene, while CYP11B1, which shares 93% homology with CYP11B2, encodes 11ß-hydroxylase, the enzyme responsible for cortisol synthesis. Now, Aldosterone and cortisol have almost the exact opposite function. Reducing cortisol increases blood pressure, while reducing Aldosterone decreases it. If the Aldosterone antagonist is not selective enough, its effect on blood pressure is nullified because of the opposite effects of cortisol and Aldosterone. In in vitro studies done at Roche, it was seen that CIN-107 retains >100-fold selectivity of Aldosterone synthase over 11β-hydroxylase.
A number of Aldosterone antagonists are being developed which are claimed to be super selective for CYP11B2. In the lead is privately held Mineralys, which is expected to launch a pivotal trial next year. Immediately behind is CinCor with its ongoing phase 2 trial. After that we have PhaseBio and Angion, which also have Aldosterone antagonists in their pipelines.
When it was in the hands of Roche, CIN-107 showed the following:
In healthy subjects, single doses of RO6836191, across a 360-fold dose range, reduced plasma and urine aldosterone levels with maximum suppression at a dose of 10 mg, but unchanged cortisol, on adrenocorticotropic hormone challenge, up to 360 mg, and increase in the precursors 11-deoxycorticosterone and 11-deoxycortisol only at or >90 mg. In conclusion, RO6836191 demonstrates that it is possible to suppress aldosterone production completely in humans without affecting cortisol production.
CinCor completed a MAD (multiple ascending dose) study of CIN-107 after Roche’s SAD (single ascending dose) study. The company now plans two Phase 2 trials and a Phase 3 trial for hypertension, a Phase 2 trial for primary aldosteronism, and one more Phase 2 trial targeting hypertension in chronic kidney disease.
In my previous coverage, I gave the following details about the hypertension trials:
A Phase 2 clinical trial “BrigHtn” is ongoing in patients whose BP is not controlled despite treatment with three antihypertensive agents, including a diuretic, referred to as treatment resistant hypertension (‘rHTN). Topline data is expected in 2H-2022. A separate Phase 2 clinical trial “HALO” was recently initiated in patients with elevated aldosterone levels whose BP is not controlled despite treatment with one antihypertensive agent, referred to as uncontrolled hypertension (‘uHTN). First patient dosing expected in 1Q-2022.
Hypertension is a huge market. According to the company, hypertension affects ~110 million adult Americans and, of those, “~35% of U.S. adults with hypertension are uncontrolled on one or more blood pressure medications.” Treatment and associated costs for high blood pressure is $131bn in the US every year.
Financials
CINC has a market cap of $728mn, and a cash balance of $137mn as of December. Moreover, its IPO raised $193mn. The company says that these funds are enough to see it through 2024. R&D expenses were $21.5 million for the full year ended December 31, 2021, while G&A expenses were $21.0 million.
Bottom Line
CinCor is doing interesting science. I have no particular interest in buying CINC stock right now because things are too early. However, by the end of this year there should be at least the following two data catalysts:
BrigHtn Phase 2 study with CIN-107 for Resistant Hypertension Enrollment Complete with Topline Results Expected in 2H 2022
Topline Data from HALO Phase 2 study with CIN-107 for Uncontrolled Hypertension Expected in 2H 2022
Once we have more data, I will take a closer look at CINC.
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