Cidara Therapeutics’ CD388 Progress and Challenges Highlighted in Earnings Call

Cidara Therapeutics Inc. ((CDTX)) has held its Q1 earnings call. Read on for the main highlights of the call.

Cidara Therapeutics Inc. recently held an earnings call that highlighted significant advancements in their CD388 program, a novel drug aimed at preventing influenza. The sentiment during the call was generally optimistic, with promising trial results and future plans for a phase 3 study. However, concerns were raised about the company’s current non-revenue generating status and challenges related to the NAVIGATE study’s design and dose-dependent efficacy.

Introduction of CD388

CD388 is positioned as a groundbreaking solution for influenza prevention, offering universal activity against all flu strains without relying on the host immune system. This innovative approach combines a novel multivalent presentation of zanamivir with a human antibody fragment to extend the drug’s half-life.

Successful Phase 1 and Phase 2a Trials

The Phase 1 single ascending dose study demonstrated that CD388 is well tolerated and has an extended half-life. Additionally, the Phase 2a human challenge study revealed substantial protective efficacy, paving the way for its progression to a phase 2b study.

Progress of NAVIGATE Phase 2b Study

The NAVIGATE study, which completed dosing of 5,041 subjects by December, is a critical step in determining the appropriate dose for the upcoming phase 3 study. Top-line data from this study are anticipated by June.

Potential Phase 3 Study

Cidara plans to initiate a phase 3 study in February, targeting high-risk comorbid and immune-compromised patients. This study aims to address unmet needs and is contingent on the results of the phase 2b study and discussions with the FDA.

R&D Day Announcement

An R&D day is scheduled for May 22, where Cidara will provide updates on the NAVIGATE trial, regulatory discussions, and plans for the phase 3 study. This event will underscore the commercial potential of CD388.

Non-Revenue Generating Status

Currently, Cidara Therapeutics is not generating revenue, as the company is primarily focused on advancing its CD388 program.

NAVIGATE Study Not Powered for Statistical Significance

The initial design of the NAVIGATE study did not account for statistical significance, prompting ongoing discussions with the FDA to revise the statistical analysis plan.

Challenges in Determining Dose-Dependent Efficacy

The NAVIGATE study faced challenges in determining dose-dependent efficacy due to varying exposure levels, which affects data confidence and subsequent steps.

Forward-Looking Guidance

Looking ahead, Cidara Therapeutics is focused on the progress of CD388, with the completion of dosing for the phase 2b NAVIGATE study and top-line data expected by June 2025. The company is in discussions with the FDA to amend the study’s statistical analysis due to the severity of the February 2025 flu season. A phase 3 study is planned for February 2026 in the Southern Hemisphere, targeting high-risk and immune-compromised populations.

In summary, Cidara Therapeutics’ earnings call conveyed a sense of optimism about the future of CD388, despite challenges related to the NAVIGATE study. The company is poised to make significant strides in influenza prevention, with upcoming trials and regulatory discussions set to shape its path forward.