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Item 8.01 Other Events.
On March 1, 2023, Cidara Therapeutics, Inc. (the “Company”), announced efficacy and safety data from a planned interim analysis of the Company’s ongoing Phase 2a trial evaluating the pre-exposure prophylactic activity of CD388 against the H3N2 influenza A virus strain, as of a February 13, 2023 data cut-off. The Phase 2a trial is a single-center, randomized, double-blind influenza challenge study in healthy volunteers designed to assess the prophylactic antiviral activity, safety, tolerability and pharmacokinetics of CD388 in healthy volunteers. The interim analysis is based on 56 subjects enrolled in the trial, with 28 subjects receiving a single dose of CD388 (150 mg) and 28 subjects receiving a placebo. The interim data for the primary efficacy endpoint of Area Under the Viral Load-Time Curve (VL-AUC) and for the secondary efficacy endpoint of influenza infection incidence for 150 mg CD388 versus placebo are shown below in Table 1.
Table 1.
| Placebo (n=28) | CD388 150 mg (n=28) | |||
| Area Under the Viral Load-time Curve (VL-AUC)- Mean (SD) |
16.1 (11.9) | 10.7 (8.0) | ||
| PCR confirmed influenza infection- n (%) |
14 (50%) | 6 (21.4%) |
As shown in Table 1, despite the small sample size in this planned interim analysis, a decrease in viral replication in the upper respiratory tract and influenza infection was observed in participants receiving a single dose of CD388 when compared to placebo. No treatment emergent adverse events leading to study discontinuation or serious adverse events were reported in the interim analysis. All participants included in the interim analysis received either CD388 or placebo and were then challenged with influenza five days later.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Cidara Therapeutics, Inc. |
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| Date: March 1, 2023 | /s/ Jeffrey Stein, Ph.D. | |||
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Jeffrey Stein, Ph.D. | |||
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President and Chief Executive Officer (Principal Executive Officer) | |||