On 19 January, Caladrius Biosciences announced the initiation of its Phase IIb FREEDOM trial evaluating the efficacy and safety of CLBS16 as a treatment for coronary microvascular dysfunction (CMD). CMD is a type of non-obstructive coronary artery disease attributed to dysfunctional microvasculature that leads to reduced blood flow to the heart and symptoms of angina. CLBS16 is an intracoronary injection of autologous CD34+ cells with the potential to stimulate the growth of new microvasculature in the oxygen-deprived heart. GlobalData believes that while the early, preliminary data generated so far are promising and there is an established unmet need for novel treatments approaches in the space, concerns around the therapy’s scalability, cost, and durability of a potential treatment effect will impact its market uptake. Despite its expected minimal penetration, given its estimated high annual cost of therapy and the projected market growth, CLBS16 is forecast to generate US sales of $346M by 2028, according to GlobalData.

The number of diagnosed prevalent cases of microvascular angina will grow between 2018 and 2028 from 3,886,426 cases in 2018 to 4,518,109 across the seven major markets (7MM: the US, Germany, France, Italy, Spain, the UK, and Japan). In the US, diagnosed prevalent cases are forecast to reach 1,319,214 cases in 2028.

Key opinion leaders (KOLs) interviewed by GlobalData emphasised that microvascular angina has been gaining increasing recognition among the medical community and there is renewed interest in better understanding its underlying causes. Furthermore, optimal medical treatment for angina due to CMD is undefined. There are no drugs that specifically target the different mechanisms that trigger microvascular angina in different patients. Standard antianginal drugs are thus employed to relieve symptoms, yet this approach frequently proves ineffective. While the need for therapy such as CLBS16 is evident, KOLs raised concerns regarding the potentially high cost of therapy associated with cell therapies, which could significantly dampen market prospects. Compared to the angina standard of care, a market that is mostly filled with generics, cell therapy prices could be priced in the $50,000–100,000 range per full course of treatment, a factor that would constitute a significant barrier to entry. What’s more, the high cost cannot be justified before significant durability of response is demonstrated, which could lead to initial reimbursement issues

In November 2019, Caladrius Biosciences presented initial results from CLBS16’s Phase IIa ESCaPE-CMD at the American Heart Association Scientific Sessions and full data at the Society for Cardiovascular Angiography & Intervention (SCAI) 2020. Data showed highly statistically significant improvement in coronary flow reserve correlating with symptom relief after a single intracoronary injection of CLBS16. The FREEDOM trial is a 105-patient double-blind and placebo-controlled clinical trial further investigating the efficacy and safety of CLBS16.

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