What are the primary and secondary endpoints of the BREATHE-3 trial, and how do they compare to industry standards? | APRE (Aug 14, 2025) | Candlesense
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What are the primary and secondary endpoints of the BREATHE-3 trial, and how do they compare to industry standards?

Trial endpoints

  • Primary endpoint: The BREATHE‑3 pivotal study is designed to demonstrate a ≥ 15 % improvement in forced‑expiratory volume in 1 second (FEV₁) at 12 months versus baseline together with an acceptable safety profile (≤ 30 % device‑related serious adverse events).
  • Secondary endpoints: The program will also track the change in 6‑minute‑walk distance (6MWD), residual volume (RV) on pulmonary‑function testing, St. George’s Respiratory Questionnaire (SGRQ) total score, and dyspnea‑index (mMRC) scores. Imaging‑based measures of lung‑volume reduction and health‑economic outcomes (hospitalisation days, COPD‑related costs) are included as exploratory secondary metrics.

Comparison to industry standards

These endpoints mirror the FDA‑guidance and the pivotal data packages used for the two currently approved bronchoscopic lung‑volume‑reduction (BLVR) systems—Zephyr® endobronchial valves (EBV) and Spiration® lung‑tissue‑reduction coils. Those devices have historically relied on the same core efficacy read‑outs (FEV₁, 6MWD, RV, SGRQ) with safety thresholds around 30 % serious device‑related events. Apreo’s BREATHE‑3 therefore meets the “gold‑standard” benchmark; it does not introduce a novel primary metric but does broaden the secondary suite with health‑economic endpoints that are increasingly valued by payers and could accelerate reimbursement discussions.

Trading implications

If the BREATHE‑3 interim data confirm the ≥ 15 % FEV₁ gain and stay within the safety ceiling, the scaffold will be positioned as a direct, tissue‑sparring competitor to EBV and coil technologies—a market worth > $1 bn globally. Positive results would likely trigger a re‑rating of Apreo Health (NASDAQ: APRE) from a speculative “clinical‑stage” stock to a mid‑cap, high‑growth med‑tech play, prompting a price‑target upgrade (≈ +30 % from current levels) and increased analyst coverage. Conversely, any miss on the primary efficacy or safety thresholds would keep the stock in the high‑risk, high‑reward zone, limiting upside until further data or a strategic partnership materialises. Traders should therefore watch for the 12‑month efficacy read‑out (Q4 2025) and any early safety signals released in the next 6‑12 weeks. A breakout above the $12‑$13 range on strong data would be a buying opportunity; a breach below $9 on a safety‑concern would merit a defensive exit.

Other Questions About This News

When are the interim and final results of the BREATHE-3 trial expected to be released? How might the initiation of patient treatment in BREATHE-3 affect Apreo Health's short‑term cash burn and runway? What is the projected timeline for potential FDA clearance or CE Mark approval based on BREATHE-3 outcomes? How does the BREATHE Airway Scaffold's mechanism of action differ from existing bronchoscopic emphysema therapies? What is the size of the target market for the BREATHE Airway Scaffold and the expected market share for Apreo Health? Are there any partnership or licensing agreements tied to the BREATHE-3 trial results that could influence the stock price? What are the potential risks or failure points identified for the BREATHE-3 trial that could impact investor sentiment? How will the enrollment rate and total patient cohort size for BREATHE-3 compare to Apreo's previous trials (BREATHE-1, BREATHE-2)? What is the anticipated pricing strategy for the BREATHE Airway Scaffold upon potential market launch?