New York-headquartered biopharma company TG Therapeutics has revealed new data for its investigational therapy ublituximab, which demonstrated superiority over Sanofi’s Aubagio in patients with relapsing forms of multiple sclerosis (MS).
The data, from the Phase III ULTIMATE I & II studies, evaluated ublituximab – a novel glycoengineered anti-CD20 monoclonal antibody – in patients with RMS.
Both studies hit their primary endpoint, with ublituximab treatment demonstrating a statistically significant reduction in the annualised relapse rate (ARR) over a 96-week period compared to Aubagio (teriflunomide).
In the ULTIMATE I trial, ublituximab treatment resulted in an ARR of 0.076 compared to 0.188 for Aubagio – a relative reduction of approximately 60%.
Similarly, in the ULTIMATE II trial, treatment with TG Therapeutics’ drug resulted in an ARR of 0.091 compared to 0.178 for Aubagio, representing a relative reduction of around 50%.
In addition, MRI results found the total number of T1 Gadolinium (Gd) enhancing lesions were reduced following treatment with ublituximab by 97% and 96% relative to Aubagio treatment in the ULTIMATE I & II trials respectively.
Further results from the ULTIMATE I trial found that 44.6% of ublituximab treatred patients achieved no evidence of disease activity (NEDA) – a 198% improvement over Aubagio.
In the ULTIMATE II trial, 43% of ublituximab treated patients achieved NEDA, representing a 277% improvement over Sanofi’s drug.
Researchers found that ublituximab was also generally well tolerated, with the proportion of patients in the ublituximab group with adverse events found to be similar to the Aubagio group in a pooled analysis of both studies.
Data from the ULTIMATE I & II studies are expected to support a biologics license application (BLA) submission to the US Food and Drug Administration for ublituximab in RMS in the third quarter of 2021.
We believe these data showcase ublituximab to be a highly efficacious treatment option with a generally well tolerated safety profile. If approved, ublituximab will be the only CD20 offered in a convenient one-hour infusion every six months, following the first dose,” said Michael Weiss, executive chairman and chief executive officer of TG Therapeutics.