Data from a couple of late stage trials hit press in the biotechnology sector yesterday and the numbers have translated to some considerable movement in the market capitalizations of the companies in question.
Here is a look at the two programs that reported data with a description of what was involved in each and where we expect companies sponsoring them to go next in terms of both operational advance related to the programs in question and market capitalization.
So, the two companies in focus are Galectin Therapeutics Inc (NASDAQ:GALT) and Revance Therapeutics, Inc. (NASDAQ:RVNC).
This is actually one that we looked at yesterday, highlighting the company’s announcement on Monday evening that it was set to put out data from a phase IIb trial investigating Galectin’s lead development asset – a drug called GR-MD-02.
The company was trying to show that GR-MD-02 could be effective in treating patients with NASH cirrhosis and this release was the culmination of its efforts to-date to do just that.
And as it turns out, and unfortunately for the company, things don’t look so great.
Some might remember that this one failed to hit on its primary endpoint in a phase IIa study late last year but, for reasons rooted in trial design, expectations were that this phase IIb might turn out some more positive results. As per the data, however, the trial did not meet its primary endpoint of a reduction in hepatic venous pressure gradient versus placebo at year 1, which is pretty much an industry gold standard in this NASH indication.
It might not be all bad, however. The above mentioned hepatic venous pressure gradient is a measure of high blood pressure in vessels that serve the liver and, in many patients with serious liver disease (as is often the case in these NASH patients), esophageal varices, which are enlarged veins in the tube that connects the throat and stomach, can be a problem. Esophageal varices can impact hepatic venous pressure and this – in turn – might affect the results.
And it seems that this might have been the case. In patients that had esophageal varices, the drug failed to meet on its endpoint. Narrow the data to patients without esophageal varices, however, and there was a stat sig improvement in the venous pressure gradient. The split between patients with and without esophageal varices was around fifty-fifty.
So what’s next?
Now it’s all about what the company plans to do in a pivotal. If management can persuade the FDA to accept a protocol that focuses only on those patients without esophageal varices. If this is the case, there’s a decent chance of a successful pivotal.
Next up, Revance.
This one’s a little more positive.
Revance put out data on Tuesday as relates to two pivotal trials set up to investigate a drug called RT002 in a target indication of the alleviation of moderate-to-severe glabellar lines (basically, wrinkles on the forehead).
As per the data, both of the phase III trials met the primary composite endpoint by delivering highly statistically significant improvement against placebo in reducing the severity of glabellar lines.
So that’s great news for the company and its shareholders but there’s more here. The data also showed that the glabellar lines in question only returned to baseline severity after around 6 months’ post-treatment.
Why is this important? Because the company is targeting the same market that Allergan plc (NYSE:AGN) targets with its multi-billion dollar blockbuster Botox. However, Botox only lasts three months. If Revance can get this asset to market in its target wrinkle reduction indication and – at the same time – can get a label that highlights its potential for use as a six-month alternative to Botox, the company could be in for a real payday.
So what’s next?
There’s a long-term safety study that needs completing before submission to the FDA, so that’s next on the list for Revance. The study should wrap up at some point between the the end of the second and the end of the third quarter next year, subsequent to which (assuming there are no major safety concerns flagged up on the back of the study) Revance will submit a new drug application and the asset will go under review.