Caladrius Biosciences Stops Enrollment In Mid-Stage Heart Disease Study

Caladrius Biosciences Inc CLBS suspended patient enrollment in its Phase 2b FREEDOM Trial of Xowna for coronary microvascular dysfunction (CMD).
As previously communicated, the pandemic impacted the enrollment in the FREEDOM Trial coupled with supply chain issues making enrollment much slower and challenging to accelerate.
The FREEDOM trial enrolled approximately one-third of the targeted 105 patients, and at this rate, more than four years would likely be required to reach the primary endpoint follow-up at 6 months post-treatment for all subjects.
Also Read: Caladrius Biosciences To Merge With Privately-Held Cend Therapeutics.
Caladrius believes that this revised timeline is not viable for financial and commercial reasons and requires an alternative development plan.
The company intends to conduct an interim analysis of the data from not less than the first 20 patients enrolled using the 6-month follow-up data to evaluate the efficacy and safety of Xowna in subjects with CMD and corroborate the ESCaPE-CMD study results.
The interim analysis is expected to be completed in August 2022.
Price Action: CLBS shares are up 2.17% during the premarket session on the last check Tuesday.