Phase III ULTIMATE I & II trials of TG 1101 shows improvement for multiple sclerosis.- TG Therapeutics

As previously reported, both studies met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) over a 96-week period (p<0.005 in each trial). these studies investigated the safety and efficacy of a one-hour 450mg infusion of ublituximab every six months, following the day 1 infusion (150mg over four hours). the ultimate i & ii trials were conducted under a special protocol assessment (spa) agreement with the fda and formed the basis for a biologics license application (bla) submission for ublituximab in rms which was submitted late last month.></0.005>

In ULTIMATE I, treatment with ublituximab resulted in an ARR of 0.076 compared to 0.188 for teriflunomide, representing a relative reduction of approximately 60% (p<0.0001). in ultimate ii, treatment with ublituximab resulted in an arr of 0.091 compared to 0.178 for teriflunomide, representing a relative reduction of approximately 50% (p="0.0022)." total number of t1 gadolinium (gd) enhancing lesions were reduced as a result of ublituximab treatment by 97% and 96% relative to treatment with teriflunomide in ultimate i & ii, respectively (p><0.0001). new or enlarging t2 lesions were reduced as a result of ublituximab treatment by 92% and 90% relative to treatment with teriflunomide in ultimate i & ii, respectively (p><0.0001).></0.0001).></0.0001).></0.0001).>

Ublituximab was generally well tolerated with no unexpected safety signals. Overall, the proportion of patients in the ublituximab group with adverse events was similar to the teriflunomide group in a pooled analysis of both studies (approximately 88% in each treatment group). During the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) additional data were presented in two presentations.

If approved, ublituximab would become the third MS drug cleared that works by targeting a protein found on B cells after Ocrevus and Novartis' Kesimpta. There are a wide range of options that include oral drugs like Biogen's Tecfidera and Novartis' Gilenya as well as older biologic medicines.

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