APD403 is based on the selective dopamine antagonist amisulpride, the same active ingredient as in BARHEMSYS™. It is being developed as an intravenous injection for cancer patients to be administered immediately before they receive chemotherapy to prevent acute CINV, and as an oral tablet to prevent delayed CINV.
APD403 has successfully completed one proof-of-concept and one Phase 2 dose-ranging study demonstrating it is well tolerated and effective at preventing acute and delayed CINV. Acacia Pharma intends to advance APD403 into Phase 3 studies following completion of a further Phase 2 study.
CINV is one of the most common and feared side effects of cancer chemotherapy. In patients receiving highly emetogenic chemotherapy (e.g. cisplatin and anthracycline/cyclophosphamide in breast cancer) the incidence of CINV is over 90%. There are also many moderately emetogenic chemotherapy agents and regimens which can cause CINV in 30-90% of patients.
Nausea and vomiting can occur on the day of chemotherapy (acute CINV) and can persist for two to five days after chemotherapy (delayed CINV). CINV has a significant effect on quality of life and can compromise patient health. Severe CINV may necessitate a delay or reduction in chemotherapy and can ultimately lead to the withdrawal of treatment. The goal of CINV management is the prevention, rather than treatment, of symptoms.