TG Therapeutics to Present Results from the ULTIMATE I & II Phase 3 Trials Evaluating Ublituximab in Multiple Sclerosis at th...
March 04 2021 - 4:30PM
TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that
results of the ULTIMATE I & II Phase 3 trials evaluating
ublituximab, the Company’s novel, glycoengineered anti-CD20
monoclonal antibody, in relapsing forms of multiple sclerosis (RMS)
have been selected for presentation at the upcoming American
Academy of Neurology (AAN) annual meeting, being held virtually
April 17 – 22, 2021. The abstract is available online and can be
accessed via the below link or on the AAN meeting website at
www.aan.com.
Michael S. Weiss, the Company’s Executive Chairman and Chief
Executive Officer stated, “We are highly encouraged by the positive
topline results from the ULTIMATE I & II Phase 3 trials
announced this past December, showing both studies met their
primary endpoint with ublituximab treatment demonstrating a
statistically significant reduction in annualized relapse rate
(ARR) over a 96-week period. Importantly, ublituximab treatment
resulted in an ARR of less than 0.10 in each of the studies.” Mr.
Weiss continued, “We look forward to presenting additional data
from the ULTIMATE I & II Phase 3 trials during the AAN
conference including safety and secondary endpoint analyses and to
working towards a BLA submission targeted around mid-year
2021.”
Presentation Details
Title: Efficacy and safety of ublituximab
versus teriflunomide in relapsing multiple sclerosis: Results of
the Phase 3 ULTIMATE I and II trials
- 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 TRIALSULTIMATE 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 60% and 50%,
respectively, over teriflunomide. Data from these studies are
intended to support a Biologics License Application (BLA)
submission for ublituximab in RMS targeted in mid-year 2021.
Additional information on these clinical trials can be found at
www.clinicaltrials.gov (NCT03277261; NCT03277248).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 StatementThis 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
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) and, if approved,
commercialization, and the potential benefits of ublituximab in
treating patients.
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: |
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Investor Relations |
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Email: ir@tgtxinc.com |
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Telephone: 1.877.575.TGTX (8489), Option 4 |
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Media Relations: |
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Email: media@tgtxinc.com |
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Telephone: 1.877.575.TGTX (8489), Option 6 |
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