TG Therapeutics Announces Presentation of Data from the ULTIMATE I & II Phase 3 Trials of Ublituximab in Multiple Sclerosis a...
June 18 2021 - 2:00PM
TG Therapeutics, Inc. (NASDAQ: TGTX), today
announced the presentation of data from the ULTIMATE I &
II global, active controlled, Phase 3 trials
evaluating ublituximab, the Company’s investigational novel,
glycoengineered anti-CD20 monoclonal antibody, compared to
teriflunomide, in patients with relapsing forms of multiple
sclerosis (RMS), during the 7th Congress of the European Academy of
Neurology (EAN). This data was previously presented at the
American Academy of Neurology (AAN) 73rd Annual Meeting.
Oral Presentation Title: Ublituximab versus
teriflunomide in relapsing multiple sclerosis (RMS): Results of the
Phase 3 ULTIMATE I and II trials
The ULTIMATE I & II 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
studies were conducted under Special Protocol Assessment (SPA)
agreement with the U.S. Food and Drug Administration (FDA).
Additionally, data from these studies are intended to support a
Biologics License Application (BLA) submission for ublituximab in
RMS targeted in the third quarter of 2021.
Data highlights from the ULTIMATE I & II Phase 3 studies in
patients with RMS include:
Primary Endpoint: Annualized Relapse Rate (ARR) Results
- 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).
MRI Results
- 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).
No Evidence of Disease Activity (NEDA) Results
- In ULTIMATE I, 44.6% of ublituximab treated
patients achieved NEDA representing a 198% improvement over
teriflunomide (p <0.0001).
- In ULTIMATE II, 43% of ublituximab treated
patients achieved NEDA representing a 277% improvement
over teriflunomide (p<0.0001).
Prespecified Pooled Disability Results
- A very low rate of disability progression was observed across
all treatment groups. Only 5.2% of ublituximab treated
patients showed a 12-week Confirmed Disability Progression (CDP),
compared to 5.9% with teriflunomide, and only 3.3% of ublituximab
treated patients showeda 24-week CDP, compared to 4.8% with
teriflunomide; neither was statistically different.
- Ublituximab treatment increased the proportion of patients
with 12-week Confirmed Disability Improvement (CDI) and 24-week
CDI, demonstrating a 116% increased chance in
12-week CDI (12% v. 6%; p=0.0003), and a 103% increased
chance in 24-week CDI (9.6% v. 5.1%; p=0.0026) compared to
teriflunomide.
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); the most common
adverse event associated with ublituximab was infusion related
reactions (47.7% of patients who received ublituximab experienced
at least one infusion-related reaction vs. 12.2 percent for the
teriflunomide group).
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).
Both studies have 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. Key
secondary MRI endpoints have also been met. Data from these studies
are intended to support a Biologics License Application (BLA)
submission for ublituximab in RMS targeted Q3 2021. Additional
information on these clinical trials can be found at
www.clinicaltrials.gov (NCT03277261; NCT03277248).ABOUT
UBLITUXIMAB Ublituximab is an investigational
glycoengineered monoclonal antibody that targets a unique epitope
on CD20-expressing B-cells. When ublituximab binds to the B-cell it
triggers a series of immunological reactions, including
antibody-dependent cellular cytotoxicity (ADCC) and complement
dependent cytotoxicity (CDC), leading to destruction of the cell.
Additionally, ublituximab is uniquely designed, to lack certain
sugar molecules normally expressed on the antibody. Removal of
these sugar molecules, a process called glycoengineering, has been
shown to enhance the potency of ublituximab, especially the ADCC
activity. Targeting CD20 using monoclonal antibodies has proven to
be an important therapeutic approach for the management of B-cell
malignancies and autoimmune disorders, both diseases driven by the
abnormal growth or function of B-cells. ABOUT MULTIPLE
SCLEROSIS Relapsing multiple sclerosis (RMS) is a chronic
demyelinating disease of the central nervous system (CNS) and
includes people with relapsing-remitting multiple sclerosis (RRMS)
and people with secondary progressive multiple sclerosis (SPMS) who
continue to experience relapses. RRMS is the most common form of
multiple sclerosis (MS) and is characterized by episodes of new or
worsening signs or symptoms (relapses) followed by periods of
recovery. It is estimated that nearly 1 million people are living
with MS in the United States and approximately 85% are initially
diagnosed with RRMS.1,2 The majority of people who are
diagnosed with RRMS will eventually transition to SPMS, in which
they experience steadily worsening disability over time. Worldwide,
more than 2.3 million people have a diagnosis of MS.1
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
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 data from the ULTIMATE I & II trials that we announce or
publish may change, or the perceived product profile may be
impacted, as more data or additional endpoints (including efficacy
and safety) are analyzed; the risk that safety issues will emerge
despite our belief that there were no unexpected safety signals
identified in the ULTIMATE I & II trials ; our ability to
complete the BLA submission for ublituximab in RMS within the
timeline projected and the risk that FDA will not accept the
submission; the risk that the clinical results from the ULTIMATE I
& II trials will not support regulatory approval of ublituximab
to treat RMS for efficacy, safety or other issues or, if approved,
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 RelationsEmail:
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 |
_________________________________________________________
1. MS Prevalence. National Multiple
Sclerosis Society
website. https://www.nationalmssociety.org/About-the-Society/MS-Prevalence.
Accessed October 26, 2020. 2. Multiple
Sclerosis International Federation, 2013 via Datamonitor p.
236.
TG Therapeutics (NASDAQ:TGTX)
Historical Stock Chart
From Mar 2024 to Apr 2024
TG Therapeutics (NASDAQ:TGTX)
Historical Stock Chart
From Apr 2023 to Apr 2024