HALO Program Update
November 28, 2022
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This presentation contains certain forward-looking statements, including, but not limited to, statements related to CinCor's business in general; the development and commercial potential of baxdrostat; expectations with respect to the planned end of Phase 2 meeting with the FDA and the anticipated timing thereof; expectations with respect to the Company's ongoing open label extension trial, ongoing clinical trials and planned Phase 3 trials, including the timing and results thereof; the therapeutic potential of baxdrostat (CIN-107), including its potential to be an effective treatment for patients with treatment-resistant hypertension, uncontrolled hypertension, CKD and primary aldosteronism, and the ability of baxdrostat to address multiple unmet needs in patients; and other statements that are not historical facts. Because such statements are subject to risks and uncertainties, actual results may differ from those expressed or implied by such forward-looking statements. Words such as "anticipates," "believes," "expected," "intends," "plan," "may", "will," "project", "estimate", "continue," and "future" or similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on CinCor's current plans, objectives, estimates, expectations and intentions, involve assumptions that may never materialize or may prove to be incorrect and inherently involve significant risks and uncertainties, including factors beyond CinCor's control, that could cause actual results, performance, or achievement to differ materially and adversely from those anticipated or implied in the statements, including, without limitation, CinCor has incurred significant operating losses since its inception; CinCor has a limited operating history and no history of commercializing products; CinCor will require substantial additional funding to finance its operations; CinCor's business is entirely dependent at this time on the success of one drug, baxdrostat; initial, interim, "top-line" and preliminary data from clinical trials announced or published from time to time may change; CinCor may not be successful in its efforts to expand its pipeline beyond baxdrostat; success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials; enrollment and retention of patients in clinical trials could be delayed; CinCor relies and will rely on third parties to conduct, supervise and monitor
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CinCor Overview 2
HALO Program Update
Phase 2 HALO trial in patients with uncontrolled hypertension
Missed primary endpoint of reduction in SBP at 8 weeks, but CinCor believes key learnings support progression into planned Phase 3 program:
- 12.6 mmHg reduction in pre-specified subgroup of Non-Hispanic/Latinos
- Safety and tolerability profile observed in HALO was similar to profile observed in treatment resistant hypertensive (rHTN) patients in BrigHtn trial
- No patient discontinued due to treatment-related adverse events
CinCor Overview 3
Objectives of HALO Phase 2 Study: uHTN* Population
Informing target population and doses for planned Phase 3 program
HALO
Placebo controlled, dose range finding in uHTN* population on 1 - 2 anti-hypertensive medications
30-35 MILLION PATIENTS with uHTN in the U.S.
Unmet medical need but payers will likely require differentiation to gain appropriate placement and reimbursement
Key Objectives
Does baxdrostat work in uHTN patients?
What doses produce robust blood pressure (BP) lowering?
Are there sub-groups of patients who respond better than others, and if yes:
- Was response defined by background BP meds effect?
- Did levels of aldosterone or renin predict response?
- Did demographic or race/ethnic characteristics contribute to response?
*uHTN: uncontrolled hypertension | CinCor Overview 4 |
HALO Phase 2 Trial in uHTN* - 249 Patients Randomized
>85% of HALO completers enrolled in the ongoing Open Label Extension (OLE) trial**
Key Inclusion Criteria | Primary Endpoint (Part 1, 8 weeks) | ||||||||
• On a stable regimen of anti-hypertensive agents for at least 8 weeks | • | Change from baseline in mean seated systolic BP | |||||||
• Seated BP ≥ 140 mmHg | |||||||||
Key Exclusion Criteria | Key Secondary Endpoints | ||||||||
• Seated SBP ≥ 180 mmHg | • Change from baseline in mean seated diastolic BP | ||||||||
• Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 | • | The percentage of patients achieving a seated BP response <130 mmHg | |||||||
2-4-weeks | 8-weeks | 4-weeks | |||||||
Screening | Run-In | Part 1: QD Double-Blind Treatment | Part 2: QD Single Blind | Safety/OLE | |||||
0.5 mg | |||||||||
Single-blind run- | Follow-Up | ||||||||
Stable medication | 1 mg | 2 mg | |||||||
in to assess | (2 weeks) or enroll | ||||||||
regimen | 2 mg | ||||||||
adherence | in OLE | ||||||||
Placebo | |||||||||
Remain on background anti-hypertensive medication(s) | Remove background Tx | ||||||||
249 Randomized -> 227 Completers of Part 1 | |||||||||
Patient Flow | |||||||||
213 Randomized -> 201 Completers | |||||||||
175 Randomized*** | |||||||||
*uHTN: uncontrolled hypertension, estimate does not include rHTN patients
- 201 patients completed HALO and 170 of those elected to participate in the OLE (170/201=85%)
- 5 patients from Part 1 that did not qualify for Part 2 and were not HALO completers elected to enroll in the OLE yielding 175 patients
CinCor Overview 5
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CinCor Pharma Inc. published this content on 28 November 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 28 November 2022 12:44:06 UTC.