Dive Brief:
- Results from a Phase 2 study of TG Therapeutics Inc.'s CD20-targeting monoclonal antibody ublituximab showed both safety and efficacy for accelerated dosing regimens, some as rapid as one hour. The company's share price in early trading ticked up just over 4% on the news.
- All T1 Gd-enhancing lesions were eliminated at week 24 in 38 of 40 patients; all 40 patients had depletion of B-cells maintained at week 24; and 39 of 40 patients were relapse-free at week 24. The rapid infusion was well-tolerated.
- The Phase 2 study will continue through to 52 weeks, and recruitment for the two ULTIMATE Phase 3 trials is expected to be completed in the first quarter of 2019.
Dive Insight:
The multiple sclerosis marketplace has become crowded. Competition includes Biogen's Tecfidera (dimethyl fumarate) and Avonex (interferon beta-1a) , Novartis' Gilenya (fingolimod), Teva's Copaxone (glatiramer acetate), and Roche's Ocrevus (ocrelizumab).
Potentially the key competitor for ublituximab will be Ocrevus. Also a CD-20-targeting monoclonal antibody, Ocrevus was the first treatment approved to treat both relapsing and the primary progressive form of multiple sclerosis. Its sales were $524 million since its launch in 2017. Ocrevus is initially dosed as an IV infusion two weeks apart and then a single IV infusion every six months, lasting 3.5 hours or longer.
The Phase 2 study reported at ECTRIMS 2018 included two new cohorts that looked at an accelerated dose of 1 hour for ublituximab, which could provide an advantage for the newer drug.
"We continue to view ublituximab as a highly comparable anti-CD 20 monoclonal antibody to Ocrevus, and possibly preferable for patients and physicians based on a more rapid infusion period and to payers, as TG Therapeutics expects to price ublituximab at a meaningful discount," said Matthew Andrews, equity analyst at Jefferies, in a note to investors.
"The 1 hour infusion appears to be well tolerated and could represent a more convenient alternative to the currently marketed anti-CD20 monoclonal antibody," said Michael S. Weiss, executive chair and CEO. "We look forward to presenting additional updated Phase 2 data, including data from all 48 patients enrolled in the Phase 2 study through 52 weeks, while we continue to enroll into our global Phase 3 ULTIMATE trials."
Ublituximab is also in late-stage development in a blood cancer combination therapy. Last October, TG Therapeutics saw a share slump of nearly 16% after feedback from the Food and Drug Administration. This concerned the data needed for approval of the combination of ublituximab with AbbVie Inc.'s Imbruvica (ibrutinib) in adults with previously treated, high-risk chronic lymphocytic leukemia. The GENUINE Phase 3 study, combining the two agents, is ongoing, and is expected to complete in August 2018.