Heron Therapeutics said that its experimental drug for treating chemotherapy-induced nausea and vomiting (CINV) met its primary endpoint in a late-stage study.
Following repeated delays, the positive news sent the company’s shares up more than 40 percent in extended trading.
Heron announced top-line results from its Phase III MAGIC study, which evaluated the safety and efficacy of investigational Sustol, the company’s 5-HT3 receptor antagonist product candidate, as part of a three-drug regimen with intravenous (IV) neurokinin-1 (NK1) receptor antagonist fosaprepitant and the IV corticosteroid dexamethasone for the prevention of delayed-onset CINV following administration of highly emetogenic chemotherapy (HEC) agents.
The injected drug, Sustol, is an extended-release version of common 5-HT3 receptor blockers, which are common treatments used for CINV. In the late-stage trial consisting of 942 patients undergoing chemotherapy, Sustol met its primary endpoint of an improvement in the proportion of patients who achieved complete response, defined as not vomiting or needing rescue medications within five days of receiving chemotherapy. The percentage of patients in the Sustol group who achieved complete response was 64.7 percent versus 56.6 percent for the comparator group. The company said that the percentage of patients who achieved complete control, defined as complete response plus no more than mild nausea during the delayed-onset phase, also reached statistical significance in favor of Sustol. The percentage of patients who experienced no nausea or infrequent nausea during the time period was significantly higher in the Sustol group and significantly more patients in the group were satisfied with their therapy based on a quality of life survey.
Heron, formerly known as A.P. Pharma, has failed two prior submissions to the FDA. The company is now on track to resubmit the drug in the middle of the year. The US Food and Drug Administration (FDA) first rejected Sustol in 2010 due to issues with the company’s bioavailability and metabolism data. The agency required Heron to conduct new studies. In 2013, the company resubmitted the drug, however the agency rejected it over manufacturing and data analysis problems.
“The MAGIC study demonstrated that use of Sustol with an NK1 receptor antagonist and dexamethasone for patients receiving HEC significantly reduced symptoms of CINV. It is significant that both arms of the study had a three-drug prophylactic regimen, which has not been previously evaluated in prior Phase 3 trials in this high-risk patient group. Symptom management in patients receiving cancer treatment represents a significant unmet medical need, and the results of this study represent another step forward in this important clinical space,” said Ian Schnadig, MD, Principal Investigator, US Oncology Research, Compass Oncology, Tualatin, Oregon.
Source: Heron Therapeutics, Inc.
Last updated: 5/29/15; 11:50am EST