Prothena Corporation PLC (NASDAQ:PRTA) just gave us an update as to the status of its pipeline, in doing so, presented us with some timeframes to work with from a development milestone perspective. Here are a few of the most important, and the ones we believe have the potential to serve up some actionable upside momentum.
We’ll start with PRX002.
This one is the company’s Parkinson’s disease treatment. It’s the drug for which Prothena and pharma giant Roche Holding Ltd. (ADR) (OTCMKTS:RHHBY) have teamed up to develop, and it’s currently in a phase Ib multiple ascending dose study. The trial is set up to establish the most effective, and the maximum tolerable dose of the drug, and there’s a secondary endpoint that will look at early stage clinical benefit. Of course, the tolerability side is the most important from a technical perspective on this trial, and the establishing of the dose will be key to carrying forward into a phase II trial, but in all honesty, we’re more interested in seeing how the clinical benefit plays out. There are a number of big pharma collaborations ongoing in the Parkinson’s disease space right now, and it’s a really hot area of biotech. If Prothena can come up with some data that hints at efficacy, and even better, replicable efficacy further down the line, we could see some instant upside. The timeline on this one is the end of the year – the company expects to release topline from the phase Ib during the fourth quarter.
Next, our focus is NEOD001. Just as with the above PRX002, NEOD001 is a protein immunotherapy treatment, but this time it’s targeting AL amyloidosis. In patients with this condition, antibody producing cells form abnormal protein fibers called light chains. The light chains stick together, and clumps of them deposit in organs in the body. These deposits cause damage to, and eventually failure of, the organs in which they reside. NEOD001 is an attempt to both clear out these deposits, and also stop them from forming, by way of a dual MOA. The drug is currently in two trials – the first trial is a phase III, and is the company’s lead development program. This should complete enrollment during the second quarter of next year, and this completion will give us some indication of final trial length. If the company hits its target completion period, we consider this as an upside catalyst. The second is a phase IIb, which is ongoing, and expected to complete mid to late next year. Topline from the trial should hit press before the close of 2017, and at the very latest during early 2018. This is a major catalyst, not only because of its relation to the phase IIb, but also because it should serve up some insight into what will by then be a fully enrolled ongoing pivotal.
Finally, we’ve got PRX003. This one is an inflammatory disease target with a current lead focus of psoriasis. It’s currently in a phase Ib multi-ascending dose, and the company expects to offer up interim data from the trial at some point during mid-2017. Psoriasis is a huge market, and is set to double over the next decade to reach $13.3 billion. If Prothena can prove during 2017 that its anti inflammatory candidate is effective in this indication, there’s plenty of upside potential. Topline from the trial is due to hit before the close of next year, so there are two major psoriasis related milestones on the cards.
There’s also the potential initiation of a phase II of the drug in this indication. Prothena expects to offer us some insight into the development strategy for this phase two some point during the final quarter of this year. Chances are we will see it initiated as interim hits, so the second half of 2017 promises to be full of upside anti inflammatory catalysts.
So that’s it – a flurry of potential upside catalyst for the next twelve to eighteen months, in conditions that all have the potential to be blockbuster markets for Prothena if the company can carry the respective drugs through to commercialization.
A nice biotech play at current levels ahead of some major catalysts, and one to keep an eye on going forward.