After the markets closed on Monday, Galectin Therapeutics Inc. (NASDAQ:GALT) announced that it is preparing to release some data from one of its lead development studies before the market open on Tuesday. In the biotechnology space, it’s not unusual to release data ahead of a market opening but, what’s slightly unusual about the situation, is that the company preannounced the announcement.
This points towards Galectin wanting to draw maximum attention to the release and, in turn, suggests that the numbers that it is set to report are going to hit press as positive.
This is speculative, of course, but, it’s not unreasonable speculation. If it’s valid, the company is going to run.
With this in mind, here is what the data relates to and what to look for on release as supportive of the above-outlined suggestion.
So, the trial in question is called NASH-CX and it’s a phase 2B trial set up to investigate the safety and efficacy of a drug called GR-MD-02 in patients with nonalcoholic steatohepatitis (NASH). For those not familiar with this condition, NASH is liver inflammation and damage caused by a buildup of fat in the liver. It’s important to make the distinction between this and something like liver hepatitis, which is similar in implications for the liver but differs in the sense that it is not caused by alcohol consumption.
Anyway, NASH is a real hot topic in the healthcare sector right now with a number of companies, big and small, rushing to try and bring their own respective treatments to market.
GR-MD-02 is Galectin’s effort in this indication and, to date, the company hasn’t had an awful lot of luck with regards to collecting positive data. Specifically, Galectin put out some phase 2 data in September last year and the numbers failed to prove one way or another whether the drug works in its target indication or not.
At the time, markets sold off on the news but suggestions that the trial was set up insufficiently to say with any certainty whether the drug can be effective in treating NASH eased sentiment somewhat. Basically, the trail was too short and patients weren’t treated for a long enough period of time (also, the trial looked at NASH fibrosis as opposed to NASH cirrhosis, which is the more prominent of these two conditions).
Which brings us to the current study and the data that is set to hit press this morning.
As noted, it derives from a phase 2B study and it’s assessing GR-MD-02 in 156 NASH patients. The primary endpoint is the reduction in hepatic venous pressure gradient versus placebo at year 1, which is pretty much an industry gold standard in the indication and, if hit, would be a strong indicator of efficacy for the asset.
As far as mechanism of action is concerned, GR-MD-02 is designed to target what’s called galectin 3, which a protein that plays a key role in the pathogenesis of fatty liver disease and fibrosis. The idea is that by stopping galectin 3 from performing its standard and natural function, the drug can inhibit (or even reverse) the progression of the disease in patients with moderate to severe state NASH.
So what’re we looking for when the data hits press this morning?
Well, the immediate and simple answer is we would love to see the drug bring about a reduction in the above-mentioned hepatic venous pressure gradient in the patients that received the active compound as part of the study. The study is set up to compare the drug to placebo, meaning as a secondary type measurement, we are looking for as wide a gap as possible between patients in the active and patients in the placebo arm, from the point of view of the pressure gradient that is at the center of this investigation. The wider the difference, the more effective the drug and the higher the chances of it reaching commercialization subsequent to a successful pivotal study.
At the same time, we also want to see a clean bill of safety.
These drugs, especially those that target galectin 3, have had some trouble with safety concerns in the past and Galectin will want to show that this iteration of a drug of this type can bring about efficacy without also inducing some potentially prohibitive tolerability concerns.
The numbers should hit press at 8:30 ET as part of a webcast with Galectin management.