TG Therapeutics to Host Investor & Analyst Event to Preview Results from the ULTIMATE I & II Phase 3 Trials of Ublituximab in Multiple Sclerosis
TG Therapeutics (NASDAQ: TGTX) has scheduled a webcast for April 16, 2021, at 8:30 AM ET for the American Academy of Neurology (AAN) Annual Meeting. The event will discuss the ULTIMATE I & II Phase 3 trials of ublituximab for treating relapsing multiple sclerosis (RMS). Results indicate a statistically significant reduction in annualized relapse rates, supporting a Biologics License Application (BLA) submission targeted for mid-2021. The ULTIMATE trials enrolled 1,094 patients across 10 countries and met primary endpoints with promising efficacy results.
- Both ULTIMATE I & II trials met their primary endpoints with a statistically significant reduction in annualized relapse rate (ARR), with reductions of approximately 60% and 50% versus teriflunomide.
- The data aims to support a Biologics License Application (BLA) for ublituximab in RMS, targeted for mid-2021.
- Forward-looking statements regarding the clinical results and BLA submission timelines carry inherent risks and uncertainties.
- Potential safety issues may arise upon full dataset analysis from the ULTIMATE trials.
Webcast to be held tomorrow, April 16, 2021 at 8:30 AM ET
NEW YORK, April 15, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the schedule of events for the upcoming American Academy of Neurology (AAN) Annual Meeting, being held virtually April 17 – 22, 2021.
ULTIMATE I & II Phase 3 Investor & Analyst Webcast
- Date & Time: Friday, April 16, 2021 at 8:30 AM ET
- Key Opinion Leader Participants:
- Lawrence Steinman, MD, of Stanford University and the Global Study Chair for the ULTIMATE I & II Phase 3 trials
- Edward J. Fox, MD, PhD, of Central Texas Neurology Consultants and Chair for the ublituximab Phase 2 trial
- Enrique Alvarez, MD, PhD, of University of Colorado Medicine
- Live Webcast: http://ir.tgtherapeutics.com/events (also archived for future review)
AAN Annual Meeting Poster Presentation Details
- Date & Time: Available for viewing beginning Saturday, April 17, 2021 at 8:00 AM ET
- Abstract Number: 4494
- Lead Author: Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University
ABOUT THE ULTIMATE I & II TRIALS
ULTIMATE I and ULTIMATE II are two independent Phase 3, randomized, double-blinded, active-controlled, global, multi-center studies evaluating the efficacy and safety/tolerability of ublituximab (450mg dose administered by one-hour intravenous infusion every 6 months, following a Day 1 infusion of 150mg over four hours and a Day 15 infusion of 450mg over one hour) versus teriflunomide (14mg oral tablets taken once daily) in subjects with relapsing forms of Multiple Sclerosis (RMS). The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University and were conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). In December 2020, we announced that 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). Ublituximab treatment resulted in an ARR of <0.10 in each of ULTIMATE I & II, with a relative reduction in ARR of approximately
ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is a fully-integrated, commercial stage biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. In addition to an active research pipeline including five investigational medicines across these therapeutic areas, TG has received accelerated approval from the U.S. FDA for UKONIQ™ (umbralisib), for the treatment of adult patients with relapsed/refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen and relapsed/refractory follicular lymphoma who have received at least three prior lines of systemic therapies. Currently, the Company has two programs in Phase 3 development for the treatment of patients with relapsing forms of multiple sclerosis (RMS) and patients with chronic lymphocytic leukemia (CLL) and several investigational medicines in Phase 1 clinical development. For more information, visit www.tgtherapeutics.com, and follow us on Twitter @TGTherapeutics and Linkedin.
UKONIQ™ is a trademark of TG Therapeutics, Inc.
Cautionary Statement
This press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Such forward looking statements include but are not limited to statements regarding the results of the Ultimate I & II studies and the Company’s plans and timelines for submission of a Biologics License Application (BLA) for ublituximab for the treatment of relapsing forms of Multiple Sclerosis (RMS).
Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the following: the risk that the interim, top-line and preliminary data from the ULTIMATE I & II trials that we announce or publish may change, or the perceived product profile may be impacted, as more patient data or additional endpoints (including efficacy and safety) are analyzed; the risk that safety issues or trends will be observed in the ULTIMATE I & II trials when the full safety dataset is available and analyzed; the risk that secondary endpoints from the ULTIMATE I & II will not be positive; our ability to complete the BLA submission for ublituximab in RMS within the timeline projected; the risk that the clinical results from the ULTIMATE I & II trials will not support regulatory approval of ublituximab to treat RMS or that we will not receive regulatory approval within the timeline projected; the risk that if approved, ublituximab will not be commercially successful; our ability to expand our commercial infrastructure, and successfully launch, market and sell ublituximab in RMS if approved; the Company’s reliance on third parties for manufacturing, distribution and supply, and a range of other support functions for our commercial and clinical products, including ublituximab; the uncertainties inherent in research and development; and the risk that the ongoing COVID-19 pandemic and associated government control measures have an adverse impact on our research and development plans or commercialization efforts. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in our other filings with the SEC. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
CONTACT:
Investor Relations
Email: ir@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 4
Media Relations:
Email: media@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 6
FAQ
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