ContraVir Pharmaceuticals Inc. (NASDAQ:CTRV) is in the process of comparing a lower dose of its compound called CMX157 with the standard dose of Gilead Sciences, Inc. (NASDAQ: GILD)’s Viread on patients with chronic HBV infection. The Phase 2b study has already kicked off and is expected to conclude in 4Q2016. But ContraVir recently shared the progress it has made in the study, saying that the first of the patients in the study has been dosed.
ContraVir Pharmaceuticals Inc. (NASDAQ: CTRV)’s ongoing Phase 2b study is the first one to directly compare a lower dose of CMX157 to the standard dose of Viread in people afflicted by HBV. The motive behind the study is to find out if CMX157 can be more effective at a lower dose in combating HBV than Viread. The success of the study should pave way for a treatment that has lower risk of side effects associated with existing therapy.
Enrolling 60 patients
ContraVir Pharmaceuticals Inc. (NASDAQ: CTRV) said that the Phase 2b study of CMX157 against Viread will enroll 60 patients. The company said the study will feature dose escalation, citing that 10 per patients per group will receive once-daily dose of 5 mg, 10mg, 25mg, 50mg or 100mg over four weeks. But two patients per cohort will receive 300mg of Viread, which is the standard dose of the drug.
Trial in animals
ContraVir’s CEO, James Sapirstein, said they are hoping that the Phase 2b study of CMX157 in humans will reflect the success they saw in animal trial of the compound. In animal test, CMX157 was found to be incredible successful in combating HBV at a lower dose. Additionally, the drug showed the ability to reduce kidney toxicity risks by significantly targeting the liver.
ContraVir Pharmaceuticals Inc. (NASDAQ: CTRV)Phase 1b trial
Besides the Phase 2b study of CMX157 that has already dosed the first patient, ContraVir is also testing the drug in other programs. The Phase 1b study CMX157 is continuing and the company said that it was on track to make the final 100mg dose. It hopes to conclude the Phase 1b trial without any safety or tolerability red flags.
CMX157 is also being tested in a Phase 2a study where ContraVir Pharmaceuticals Inc. (NASDAQ: CTRV) revealed that it has successfully competed dosing in the 50mg group. It is worth pointing out that Phase 2a study enrolled healthy volunteers in an ascending dose clinical trial.