Last Updated on May 12, 2019 by Sultan Beardsley
The American Academy of Neurology (AAN) annual meeting kicks off this weekend, and runs May 4th through the 10th. In March, TG Therapeutics (TGTX) announced the presentation of data from its ongoing open label extension (OLE) trial of ublituximab in patients with relapsing forms of multiple sclerosis. For a closer look at TGTX, I suggest reading my company analysis: An In-Depth Assessment of TG Therapeutics. Here are three things to be aware of going into this presentation:
- The initial Phase 2 data was extremely promising, prompting TGTX to initiate two phase three trials (ULTIMATE I and ULTIMATE II). This OLE data will further validate this move while providing us information on the durability of treatment with ublituximab.
- This indication could be extremely lucrative for TGTX. The global multiple sclerosis market is estimated to reach over $30 billion by 2025. Furthermore, TGTX estimates they could claim around a $1-2 billion market share in the United States alone.
- In the first quarter of 2019, Roche reported $820.5 million in global sales for Ocrevus, a medication approved for multiple sclerosis with the same mechanism of action as ublituximab. This shows uptake and use of medications similar to ublituximab.
The phase two trial of ublituximab was a 52-week trial that enrolled 48 patients. This OLE provided patients that participated in the phase two trial the option to continue on ublituximab therapy for an additional 96 weeks. Of the 48 initial patients, 37 elected to enroll in this OLE trial. Furthermore, as of October 2018, it was estimated that 11 of these 37 patients have been on the OLE protocol for 48 weeks, which is when they are to have assessments. Seeing as we are now several months later, I anticipate there are several more patients who will be added to the pool of patients from OLE with data at the 48 week follow up.
Why is this 48 week data important or meaningful? The primary endpoint of the ULTIMATE I and ULTIMATE II is the annualized relapse rate at 96 weeks. That means the data for these OLE patients will be the first look investors have at a potential annualized relapse rate for ublituximab at 96 weeks, granted it will be for a limited patient population. We can see that at 24 weeks, ublituximab compared favorably to ocrelizumab, another RMS medication with the same mechanism of action. But now, we will be able to see how it stacks up to ocrelizumab at 96 weeks. This is meaningful because, as outlined above, ocrelizumab has been posting great sales number, showing provider adoption and uptake, paving the way for ublituximab to follow in its footsteps.
In the phase 3 ULTIMATE I and ULTIMATE II trial, ublituximab is being compared to Aubagio (teriflunomide). The annualized relapse rate for Aubagio ranges from 0.319 to 0.389. If ublituximab is able to maintain good durability in preventing relapses and Aubagio performs as it did in its previous trials, I believe that ULTIMATE I and ULTIMATE II have a high likelihood of success, providing TGTX a regulatory path to this massive market.
TG Therapeutics will be presenting their data on Tuesday, May 7th at 5:30 to 6:30 ET. I would expect a press release to be issued around this time outlining details of what is being presented. A link to the current abstract is here, which largely contains information that I have outlines above. As both ULTIMATE I and ULTIMATE II are fully enrolled, top-line results are expected in the middle of 2020. This means there is still plenty of time between now and the pivotal phase 3 results, however these results may spark some buzz around TGTX, and provide positive movement going into summer oncology conference season.
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I/we long TGTX.