Citius Pharmaceuticals Kicks Off Pivotal A Phase III Trial

Citius Pharmaceuticals Kicks Off Pivotal A Phase III Trial

Picking up a position in a healthcare stock ahead of a major catalyst can be a risky strategy but is also one that serves up the potential for a high degree of reward on the position in question.

In the biotechnology space, two events more than any other are generally regarded as the major binary catalysts – pivotal trial completion (and, in turn, the reporting of data from the study in question) and PDUFA, the date by which the FDA reports its decision on a New Drug Application (NDA).

There are ways to reduce the risk associated with both of these binary events. For the former, looking for an asset with a strong mid-stage dataset in place, as collected from phase II studies, can tip the scales in favor of a successful pivotal top line data readout. For the latter, the same is true, but the data that tips the scales in favor of an FDA green light derives from a strong phase III study.

I’m always on the lookout for companies that are approaching either of these two events and that meet the just mentioned scale-tipping criteria.

One that I’m looking at right now is Citius Pharmaceuticals, Inc. (NASDAQ:).

This one is a New Jersey based biotech that has spent the last few years trying to get an asset called Mino-Lok to market. I’ll get into the asset in a bit of detail shortly but, for now, suffice to say it’s designed to overcome a problem associated with what are called central venous catheters (CVCs), which are long, thin, flexible tubes used to give medicines or blood products to patients over a long period of time, usually several weeks or more.
They are especially prevalent in oncology, where they are used to deliver chemotherapy drugs to patients with various types of cancer.

Anyway, Citius just kicked off a phase III trial that’s designed to underpin a registration application in the US on completion. The trial follows a host of early to mid-stage investigations, each of which has produced data supportive of a regulatory green light, meaning the study completion and its subsequent top line data release is exactly the type of risk-mitigated binary biotechnology event described above.

So what’s the asset?

As noted, it’s called Mino-Lok and it’s designed to reduce the requirement for physicians to remove CVCs from patients, post-insertion. The longer a patient has a CVC inserted, the higher the risk of infection. Bacteria gets caught up in the tube and spreads, increasing the risk. With that said, however, having a CVC removed is not only risky and expensive, it’s also pretty unpleasant for the patient in question.

Right now, physicians essentially try to leave the CVC in as long as possible (to avoid the risk of frequent removal) while also minimizing the risk of infection. It’s a balancing act and it’s one that sometimes goes wrong. And when infection hits, it can be a serious problem. These are cancer patients, whose immune systems are already weakened by both disease and treatment (chemotherapy). So much so that infections of this type are responsible for mortality rates up to 25% in some patients, and contribute to significant morbidities.

And this is where Min-Lok comes in. It’s an antibiotic lock therapy (the word lock here refers to the instillation of a highly concentrated antibiotic solution into an intravascular catheter) that combines minocycline with edetate disodium in 25% ethanol solution.

Essentially, it’s designed as a sort of antibiotic flush type mechanism that runs through the catheter two hours out of every day (leaving the remaining 22 hours free for treatment with an active compound) and that, theoretically, should reduce the risk of infection. Reduced infection risk reduces the necessity for removal.
So, the company wants to show that treatment with Mino-Lok can eliminate an infection (in patients that already have one) to the point that it negates the necessity for CVC removal and it’s aiming to do so as part of a phase III study (the protocol is available here, for anyone interested) that, as mentioned, just kicked off last week.

A couple of things are worth noting here.

First, that the fact that the company is going after patients that have already developed CRBSI/CLABSI (these are the types of infection being targeted) is risky in that it’s a tougher endpoint than might have been the case if the company just went after a target of reducing the potential for infection, for example.

With that said, however, it demonstrates confidence and – at the same time – falls in line with the endpoints targeted during the earlier stages of this development program.

Second, Citius is following these patients through to completion, using a clinical cure as a secondary endpoint. This could make a big difference to the labeling (and, in turn, revenue potential) of the asset when (and if) it hits markets, so it’s going to be a key data point to keep an eye on at trial completion.

So what should markets be looking for going forward?

The trial is slated to complete (primarily) in June 2018. Study completion (final) is slated for September 2018. Chances are we’ll get an interim update after primary completion but the major catalyst is top line subsequent to the September end date.

Disclosure: the author holds no positions in any of the stocks mentioned.

(Why?)

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