Kancera AB has achieved a significant regulatory milestone after receiving positive feedback from the FDA on its clinical development program for KAND567, an investigational cardioprotective therapy for ST-elevation myocardial infarction (STEMI). The FDA confirmed that the proposed development plan could support a marketing application and qualifies for Fast Track Designation, highlighting the therapy's potential to address a critical unmet medical need.
FDA Validates Clinical Development Strategy
During a written responses only pre-Investigational New Drug (IND) meeting, the FDA provided comprehensive feedback on Kancera's proposed clinical development plan for KAND567 in STEMI patients. The regulatory agency agreed that the clinical development program appears designed to address a serious aspect of the disease and that submitting a request for Fast Track Designation would be reasonable.
"The FDA's feedback validates the quality of our program and clinical development plan. The fact that our program qualifies for Fast Track Designation underlines that we are addressing a significant medical need in this patient population," said Peter Selin, CEO at Kancera.
Comprehensive Development Program Design
Kancera's proposed clinical development plan encompasses a structured approach to evaluating KAND567's therapeutic potential. The program includes a phase IIb, randomized, placebo-controlled, double-blind, multi-center study known as the FRACTIVE study, which will evaluate the cardioprotective effects of both intravenous and oral administration of KAND567 in patients with anterior STEMI undergoing primary percutaneous coronary intervention.
The development plan also incorporates other preclinical and clinical development activities required prior to conducting pivotal studies, followed by a pivotal phase III study to further evaluate KAND567's safety and effects on major cardiovascular outcomes, including mortality and heart failure.
Regulatory Pathway and Dosing Considerations
The FDA confirmed that Kancera's non-clinical data package and planned activities are sufficient for initiating a phase III study. However, the agency recommended evaluating an additional dose in the phase IIb study to better characterize the exposure-response relationship, which would support optimal dose selection for the phase III trial. The proposed dosing regimen for the phase IIb study and the general dosing strategy for the phase III study were deemed reasonable by the FDA.
Next Steps and Partnership Strategy
Following the positive FDA feedback, Kancera plans to seek scientific advice from the European Medicines Agency (EMA) as the next regulatory step. The execution of the planned FRACTIVE study remains contingent on the outcome of joint financing efforts between Kancera and Recardio to secure funding for their combined long-term business plan, as outlined in the letter of intent signed by both companies.
Kancera is a clinical-stage biotechnology company developing a new class of small molecule drugs with an immune cell modulating mode of action, specifically focused on cardiovascular diseases. The company's stock is traded on the Nasdaq First North Premier Growth Market.
