BioCardia is resuming its Phase III CardiAMP Heart Failure (HF) trial for its stem cell therapy regimen, CardiAMP, after halting the study due to the Covid-19 pandemic. On June 29, 2020, the first patient was announced to have been treated in the trial setting. The entire therapy solution, which comprises biopsy testing and a stem cell reinsertion procedure, is being trialled in patients who have previously suffered from myocardial infarction (MI) and consequently developed HF. The entire therapy process involved with CardiAMP is unlike any other treatment regimen currently seen within the HF market, which is crowded with generic drugs and novel small molecule therapies and could be a game-changer for patients and physicians alike. If CardiAMP is successful in trials, GlobalData expects that BioCardia could become a strong contender in the HF space as patients with cardiac damage post-MI could have an efficient therapy option for reverse cardiac re-modelling.

CardiAMP treatment entails the patient undergoing a hip bone marrow biopsy to render the cells viable or nonviable. These cells are then reinserted into the damaged myocardial cells via catheterisation as an autologous stem cell therapy. This treatment, therefore, involves two critical steps, the point-of-care (bedside) cell processing platform and the biotherapeutic delivery system, both of which are being assessed in the Phase III trial. The trial endpoints include six-minute walk distance, survival rate, major adverse cardiac events (MACE), time to first MACE, and a change in score of the Minnesota Living with Heart Failure Questionnaire, which are similar to those used in other major HF trials.

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In a market of expensive therapies, the limited invasiveness of the CardiAMP procedure and the one-day hospital stay post-procedure is beneficial, as many patients will have spent approximately seven days in the hospital recovering from the prior causative MI. Furthermore, with the potential regenerative nature of the therapy itself, the expense of HF medications post-heart attack might be avoided if this method proves to be a plausible alternative.

The HF market has begun to adopt a new therapeutic strategy of post-acute care, wherein patients are treated post HF exacerbation hospitalisation or MI. This strategy is aimed at tackling the high post-discharge mortality seen in HF patients. Bayer and Merck’s vericiguat, Lexicon’s antidiabetic agent Zynquista (sotagliflozin), and Amgen and Cytokinetics’ omecamtiv mecarbil are being trialled as additional therapies to standard of care; they target patients who are hospitalised for HF but are stable, or who have recently been hospitalised. Vericiguat and Zynquista have completed Phase III trials for worsening chronic HF, while omecamtiv mecarbil is undergoing Phase III trials for HF patients who are hospitalised or who were hospitalised within the past year. The objective is to target this high-risk subset of patients to improve outcomes, such as all-cause mortality and readmission for HF. Therefore, BioCardia is rejoining the HF space at a time when treatments targeting post-hospitalisation patients are at the forefront.

BioCardia’s Phase III trial aims to enrol up to 260 patients across 24 trial locations in the US and is the first multicenter clinical trial of autologous cell therapy to pre-assess the validity of cell potency in order to ensure the patients selected for treatment are those who will greatly benefit from the procedure.

As Covid-19 disrupts trials across the globe, the resumption of the CardiAMP Phase III trial is positive news for BioCardia, which endeavours to have the first FDA approved pre-screened autologous stem cell therapy for post-MI HF patients.

Cell & Gene Therapy Coverage on Pharmaceutical Technology supported by Cytiva.

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