ContraVir Pharmaceuticals Inc (NASDAQ:CTRV) investors cheer the news that the company has begun enrolling the next dosing group in its head-to-head Phase 2a dose-escalation study comparing the safety and efficacy of ContraVir’s CMX157 to tenofovir disoproxil fumarate (TDF, marketed by Gilead Sciences as Viread®) in patients with chronic hepatitis B (HBV). Importantly, investors should remain encouraged by the recent data safety monitoring board review and recommendation to proceed with the study.
ContraVir Pharmaceuticals shares reacted to the news, jumping nearly 17% to $2.29 in Monday’s trading session.
“Coupled with our recent demonstration of clinical proof of concept for CMX157 in HBV patients, the DSMB’s confirmation of CMX157’s safety profile continues to build the case for this drug’s potential as a cornerstone for combination therapy to cure HBV,” said James Sapirstein, CEO of ContraVir. “We look forward to reporting final Phase 2a data by year end, and continue to believe that CMX157 has the ideal attributes needed for use as a component of a future combination drug strategy where drug-drug interactions put high demands on safety.”
ContraVir recently announced positive interim data demonstrating strong antiviral activity and favorable safety and pharmacokinetics for CMX157. Notably, a 25 mg dose of CMX157 achieved comparable HBV viral load reduction to the standard 300 mg dose of Viread®, but with significantly reduced systemic levels of active tenofovir. Results from the completed Phase 1b and ongoing Phase 2a clinical trials suggest that CMX157 is a highly potent HBV antiviral that may mitigate the risk of kidney and bone toxicities that are associated with Viread®.
The Phase 2a multiple ascending dose clinical trial, which is designed to enroll 60 treatment-naïve patients with chronic HBV infection, compares CMX157 to tenofovir disoproxil fumarate (TDF, Gilead’s Viread®). The sequential dose escalation format consists of 10 patients per cohort receiving four weeks of a once-daily dose of 5, 10, 25, 50 and 100 mg, respectively, of CMX157, plus two patients per cohort receiving 300 mg of TDF, the standard therapeutic dose of Viread®. (Original Source)
On the ratings front, Maxim analyst Jason Kolbert reiterated a Buy rating on CTRV, with a price target of $4.00, in a report issued on October 13. The current price target implies an upside of 51.5% from current levels. According to TipRanks.com, Kolbert has a yearly average return of -15.9%, a 28.0% success rate, and is ranked #4076 out of 4180 analysts.
ContraVir Pharmaceuticals, Inc. is a development stage biopharmaceutical company which is focused primarily on the development of drugs to treat herpes zoster or shingles. The company currently developing a compound called FV-100 for the treatment of shingles. It is also developing CMX157, a potent analog of the successful antiviral drug tenofovir DF.