Caladrius Biosciences’ initiation of the Phase IIb FREEDOM trial of its autologous CD34+ stem cell therapy, CLBS16, in coronary microvascular dysfunction (CMD), is an important development milestone. While concerns regarding the therapy’s scalability, potential cost and durability of the treatment effect will impact its market uptake, the drug is forecast to generate US sales of $364m by 2028, according to GlobalData, a leading data and analytics company.

Kelly Lambrinos, Managing Analyst at GlobalData, comments: “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 there is an established unmet need for novel treatment approaches for this indication, such as CLBS16, key opinion leaders (KOLs) interviewed by GloblaData noted that the potential high cost of the therapy associated with cell therapies 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 a treatment, a factor that would constitute a significant barrier to entry. Furthermore, the high cost cannot be justified before a significant durability of response is demonstrated, which could lead to initial reimbursement hurdles.

The number of diagnosed prevalent cases of microvascular angina will grow between 2018 and 2028 from 3.9 million cases in 2018 to 4.5 million across the seven major markets (7MM*). In the US, diagnosed prevalent cases are forecast to reach 1.3 million cases in 2028. Despite its expected minimal penetration, given its estimated high annual cost of therapy and the projected market growth, GlobalData forecasts that CLBS16 will generate US sales of $346m by 2028.

Lambrinos adds: “KOLs interviewed by GlobalData emphasized that microvascular angina has been gaining increasing recognition among the medical community and there is renewed interest in better understanding and treating its underlying causes.

“In November 2019, Caladrius 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.”

7MM*: the US, Germany, France, Italy, Spain, the UK, and Japan.