ContraVir Pharmaceuticals Inc (NASDAQ:CTRV) soared into the close of last week on the back of a data release from its lead hepatitis B trial, and t looks as though this week is set to bring with it more of the same, with the company already up close to 20% just an hour into the US session.
The drug has huge potential in its target indication if it can demonstrate efficacy and (more importantly, we’ll get to why shortly) tolerability, and as such, the data just released could mark the start of a longer term upside run for ContraVir and its market capitalization.
Here’s what the latest data showed, and why it’s such an opportunity for the company.
First, a quick introduction to the drug and the indication. It’s called CMX157, and as mentioned, it’s going after hepatitis B. The current standard of care in the space right now is a drug called Viread, which Gilead Sciences, Inc. (NASDAQ:GILD) developed and now markets. The goal of any of these sorts of antiviral treatments is to reduce what’s called viral load – a measurement of the amount of a virus in an organism, typically in the bloodstream. Viread’s viral load reduction is very high – up to 99% in the vast majority of cases – and so for a drug to potentially compete with this SOC it needs to achieve a similarly high VL reduction in trials.
Of course, with Viread already well established, it would be foolish to bring a fresh antiviral to market without a kicker.
ContraVir has one, and it’s rooted in toxicity.
Viread is systemic, meaning it is administered and spread through the blood stream, and it’s active as soon as it hits the human body. This constant activation means it affects healthy cells as well as those that are infected with the virus, and the fact that systemic administration is required means that a very high dose is necessary o reduce viral load to optimal efficacy. Constant activation at high dosage levels translates to one thing in healthcare – toxicity. Side effects can be nasty, and that’s been a major draw back for Gilead and its Viread treatment since day one.
ContraVir is trying to change this with CMX157. We won’t go in to too much detail on the scientific side of things as it’s not overly necessary for the purposes of this discussion, but it’s suffice to say that the drug only activates when it hits the liver. This is where the vas majority of viral particles reside, and because of this highly selective targeting, a far lower dose of the drug s required to reduce the viral load to a similar rate as does Viread.
Or at least, that’s what the company wanted to try and show. And it did.
The data showed that the drug was as effective as Viread – achieving 99% reduction in viral load when compared to baseline, on average across the sample – and at (and here’s the kicker) less than one tenth of the dose.
So essentially here we’ve got the same drug (the active compound is the same – tenofovir) achieving the same impact (99% reduction) at a dose that vastly reduces the toxicity associated with therapy.
That’s why markets are so excited about this one, and why the company is up nearly 70% on last weeks’ average price.
So what’s next?
Well, this was just interim, and the trial isn’t set to close out officially until December. There are two more dosing levels to look at – 50mg and 100mg – and these datasets will complete the analysis when they come in. We’d like to see a continuation of the viral load reduction from baseline across all dose levels as indicative of a clean sweep of efficacy for the trial.
Topline is the next major upside catalyst, and if the company can successfully put together a protocol for a pivotal, there’s plenty of upside run room left medium to long term.
One to watch.