Rugocrixan (KAND567)

Rugocrixan is Novakand Pharma’s lead project with three completed phase II-studies.

The project was acquired from AstraZeneca in pre-clinical stage in 2016. Novakand Pharma has thereafter advanced the project into clinical development and completed six phase I and II studies. As of today, more than 170 healthy subjects and patients have been treated with rugocrixan.

FRACTAL

FRACTAL is a completed clinical phase IIa study of rugocrixan in STEMI in connection with percutaneous coronary intervention (PCI). FRACTAL was a randomized, two-armed, double-blinded, placebo-controlled multicenter study with the primary objective to evaluate safety and tolerability and secondary objective to evaluate signals of cardioprotective effect.

• The primary objective was met and the results demonstrated that rugocrixan is safe and tolerable.
• The secondary objective was also met, as rugocrixan demonstrated a numerical reduction of intramyocardial hemorrhage (>30%, P=0.19), which is associated with an increased risk of death, heart failure or new infarct.

The company intends to advance the development program in acute myocardial infarction through partnerships and is now working with the preparations for the FRACTIVE study, a planned phase IIb study in STEMI.

FRACTIVE

FRACTIVE is a planned phase IIb study with rugocrixan in STEMI in connection with PCI. The phase IIa FRACTAL study demonstrated that rugocrixan has the potential to reduce the risk of intramyocardial hemorrhage (IMH). IMH is the most severe form of cardiac tissue injury post PCI and is strongly associated with an increased risk of major adverse cardiovascular events (death, heart failure and new infarct).

The planned FRACTIVE study is a randomized, two-armed, double-blinded, placebo-controlled multicenter study with the primary objective to demonstrate cardioprotective effects with statistical power (i.e. proof-of-concept in human).

KANDOVA

KANDOVA is a recently completed combined phase Ib/IIa study with rugocrixan in ovarian cancer patients with relapse from carboplatin. All study subjects received active drug, i.e. no study subjects received placebo. In total, 18 patients were recruited in the study and evaluated with regards to the primary objective – safety and tolerability. 15 of these study subjects completed at least two treatment cycles, which was the study requirement to be evaluable with regards to the secondary objective – anti-tumor effect. Study subjects were followed for up to six carboplatin treatment cycles.

In June, 2025, Kancera reported positive top-line results:

• The primary objective was met – to determine the recommended dose and evaluate safety and tolerability.
• The secondary objective – to show signals of KAND567’s anti-tumor effect in combination with carboplatin, was also met.