- Primary Endpoint of Preventing Delayed CINV Met With High Significance
Acacia Pharma Ltd ("Acacia Pharma" or "the Company"), a specialty pharmaceutical company developing supportive care products for post-surgical and cancer patients in the US and international markets, announces positive results from its Phase 2 study of APD403 in the prevention of chemotherapy-induced nausea & vomiting (CINV).
CINV occurs in approximately 70% of all cancer patients receiving chemotherapy and in 90% of those receiving highly emetogenic chemotherapy (HEC). It is one of the most significant and feared side effects of cancer therapy and a major concern for patients and caregivers. CINV occurs in two phases: the acute phase occurring in the first 24 hours after chemotherapy; and the delayed phase, lasting for a further four days. Despite significant improvements in managing the condition and the availability of a range of anti-emetics, there remains a clear unmet need to reduce the incidence of CINV, in particular the occurrence of nausea in the delayed phase.
The randomised, double blind, Phase 2 study was conducted in 342 cancer patients receiving HEC (either high-dose cisplatin, or cyclophosphamide and an anthracycline for breast cancer). The trial compared 3 doses of APD403 against placebo in the delayed phase of CINV. All patients received the same acute-phase anti-emetic prophylaxis.
The primary endpoint was complete response (no vomiting or retching and no requirement for anti-emetic rescue medication) in the period 24-120 hours after the administration of chemotherapy. APD403 was significantly superior to placebo at preventing delayed CINV, with the optimal dose improving the complete response rate by 26% (p=0.002) and significantly (p<0.05) reducing the incidence of both nausea and vomiting, compared to placebo. Complete response in the overall phase (0-120 hours) was also significantly improved (p=0.015). The safety profile was excellent, with fewer adverse events reported in each of the APD403 arms than in the placebo arm. Detailed data from this study will be presented at an upcoming scientific meeting and submitted for publication in a peer-reviewed journal.
Acacia Pharma's CEO, Dr Julian Gilbert, commented: "We are delighted with these results. Oncologists seek a product with an alternative mechanism of action that can be added to current anti-emetic regimens to better manage CINV and, in particular, improve the delayed phase response. Based on these impressive data, APD403 appears to meet this profile. We believe that APD403 has the potential to become a mainstay of CINV management and to contribute greatly to the well-being of cancer patients. We look forward to confirming these results in Phase 3 trials and providing physicians and patients with a new and effective mechanism for managing CINV."
APD403 is a novel and proprietary product containing the dopamine antagonist amisulpride, which Acacia Pharma is also developing as APD421 for the prevention and treatment of post-operative nausea & vomiting (PONV).