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Caladrius Biosciences Inc (NASDAQ: CLBS) suspended patient enrollment in its Phase 2b FREEDOM Trial of Xowna for coronary microvascular dysfunction (CMD).
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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.
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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.
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Also Read: Caladrius Biosciences To Merge With Privately-Held Cend Therapeutics.
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Caladrius believes that this revised timeline is not viable for financial and commercial reasons and requires an alternative development plan.
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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.
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The interim analysis is expected to be completed in August 2022.
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Price Action: CLBS shares are up 2.17% during the premarket session on the last check Tuesday.
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