Arix Bioscience PLC (ARIX) Arix Bioscience PLC: Imara Presents
Clinical and Preclinical Tovinontrine (IMR-687) Data at the
American Society of Hematology (ASH) Annual Meeting 2021
13-Dec-2021 / 15:53 GMT/BST Dissemination of a Regulatory
Announcement, transmitted by EQS Group. The issuer is solely
responsible for the content of this announcement.
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Arix Bioscience plc
Imara Presents Clinical and Preclinical Tovinontrine (IMR-687)
Data at the American Society of Hematology (ASH) Annual Meeting
2021
LONDON, UK, 13 December 2021: Arix Bioscience plc ("Arix",
LSE:ARIX), a global venture capital company focused on investing in
and building breakthrough biotech companies, notes that its
portfolio company, Imara Inc. (Nasdaq: IMRA), a clinical-stage
biopharmaceutical company dedicated to developing and
commercialising novel therapeutics to treat subjects suffering from
rare inherited genetic disorders of hemoglobin and other serious
diseases, today announced the presentation of 12-month data from
its Phase 2a open-label extension (OLE) trial for tovinontrine
(IMR-687) as a potential treatment for sickle cell disease (SCD) at
the American Society of Hematology (ASH) Annual Meeting, being held
between December 11-14, 2021.
In the presentation, Imara observed that tovinontrine was
generally well-tolerated as a monotherapy as well as in combination
with hydroxyurea. There were no clinically significant changes in
lab safety data, ECGs or vital signs, and no patients have
discontinued the study due to adverse events.
In addition to the 12-month OLE data, Imara also reported
preclinical data studying the effects of tovinontrine in
beta-thalassemia mouse models. The preclinical results showed
tovinontrine improved markers of beta-thalassemia, including an
increase in total hemoglobin and red blood cell count. Based in
part on these results, Imara is currently conducting the Forte
Phase 2b clinical trial of tovinontrine in beta-thalassemia and
expects to report data from transfusion-dependent subjects with
beta-thalassemia in the first quarter of 2022.
The announcement can be accessed on Imara's website at:
https://imaratx.com/ and full text of the announcement from Imara
is contained below.
[ENDS]
For more information on Arix, please contact:
Arix Bioscience plc
+44 (0)20 7290 1050
ir@arixbioscience.com
Powerscourt Group
Sarah MacLeod, Ibrahim Khalil
+44 (0)20 7250 1446
arix@powerscourt-group.com
About Arix Bioscience plc
Arix Bioscience plc is a global venture capital company focused
on investing in and building breakthrough biotech companies around
cutting-edge advances in life sciences.
We collaborate with exceptional entrepreneurs and provide the
capital, expertise and global networks to help accelerate their
ideas into important new treatments for patients. As a listed
company, we are able to bring this exciting growth phase of our
industry to a broader range of investors.
www.arixbioscience.com
Imara Press Release
Imara Presents Clinical and Preclinical Tovinontrine (IMR-687)
Data at the American Society of Hematology (ASH) Annual Meeting
2021
12-month Phase 2a open-label extension clinical data in sickle
cell disease shows patients on tovinontrine maintained reduced
annualized rate of vaso-occlusive crises
BOSTON, Dec. 13, 2021 (GLOBE NEWSWIRE) -- Imara Inc. (Nasdaq:
IMRA), a clinical-stage biopharmaceutical company dedicated to
developing and commercializing novel therapeutics to treat subjects
suffering from rare inherited genetic disorders of hemoglobin and
other serious diseases, today announced the presentation of
12-month data from its Phase 2a open-label extension (OLE) trial
for tovinontrine (IMR-687) as a potential treatment for sickle cell
disease (SCD) at the American Society of Hematology (ASH) Annual
Meeting, held December 11-14, 2021.
"These 12-month OLE data highlight the potential for
tovinontrine to have longer term impact on VOC reductions. They
also build upon previously-reported positive VOC results from the
Phase 2a and OLE clinical trials," said Rahul Ballal, Ph.D.,
President and Chief Executive Officer of Imara. "Reducing VOC rate
is an established endpoint for regulatory approval and is becoming
the primary endpoint of our ongoing Ardent Phase 2b clinical trial
of tovinontrine in patients with sickle cell disease. We expect to
report initial VOC data from the Ardent clinical trial in the first
quarter of 2022 and continue to work with the FDA on a path towards
registration."
SCD OLE Data Highlights: Imara is conducting a four-year OLE
clinical trial, a safety and tolerability study comprised of
patients who completed Imara's Phase 2a clinical trial of
tovinontrine in SCD. Subjects in the OLE clinical trial have
received a once-daily dose of tovinontrine of 200 mg, and are in
the process of being dose escalated to a once-daily dose of up to
400 mg. Of the 26 subjects enrolled, 21 were evaluable at month 12
as of the data cut-off.
Tovinontrine was generally well-tolerated as a monotherapy as
well as in combination with hydroxyurea. There were no
clinically-significant changes in lab safety data, ECGs or vital
signs, and no patients have discontinued the study due to adverse
events. The median annualized VOC rate was reduced by 38% in
subjects previously in the placebo group in the Phase 2a clinical
trial (N=7), with median annualized VOC rates of 5.0 (Phase 2a) and
3.1 (OLE) per year; median duration of treatment was 6.4 months and
11.6 months, respectively.
The low median annualized VOC rate for tovinontrine-treated
patients in the Phase 2a clinical trial was maintained in subjects
in the OLE clinical trial (N=14), with median annualized VOC rates
of 0 (Phase 2a) and 2.0 (OLE) per year; median duration of
treatment was 6.4 months and 11.8 months, respectively.
22% (4/18) of evaluable subjects had an absolute increase in
fetal hemoglobin (HbF) greater than 3%. 47% (9/19) of subjects had
an absolute increase in F-cells greater than 6%; F-cell increases
were observed in 18 out of 19 evaluable subjects.
"We're happy to be closing out 2021 by sharing positive 12-month
VOC data for tovinontrine as a potential candidate to treat sickle
cell disease," said Dr. Ballal. "The Imara team is looking forward
to making further progress in 2022 towards our goal of delivering
accessible, effective treatment options for patients suffering from
disorders of hemoglobin."
Beta-thalassemia Preclinical Data Highlights: In addition to the
12-month OLE data, Imara also reported preclinical data studying
the effects of tovinontrine in beta-thalassemia mouse models. The
preclinical results showed tovinontrine improved markers of
beta-thalassemia, including an increase in total hemoglobin and red
blood cell count. Based in part on these results, Imara is
currently conducting the Forte Phase 2b clinical trial of
tovinontrine in beta-thalassemia and expects to report data from
transfusion-dependent subjects with beta-thalassemia in the first
quarter of 2022.
Presentations at the American Society of Hematology (ASH) Annual
Meeting:
Title: Treatment with IMR-687, a Highly Selective PDE9
Inhibitor, Increases HbF and Reduces VOCs in Adults with Sickle
Cell Disease in a Long-Term, Phase 2a, Open-Label Extension Study
Abstract: 2046 Presenter: Biree Andemariam, M.D., Associate
Professor at UConn School of Medicine, Director of the New England
Sickle Cell Institute at UConn Health
Title: PDE9 Inhibition By IMR-687 Improves Markers of
Beta-Thalassemia in the Hbbth1/th1 Experimental Mouse Model
Abstract: 945 Presenter: Jennifer O'Cain, Ph.D., Imara Inc. The
presentations will be available on the Investors section of the
Imara website.
About Tovinontrine (IMR-687) Tovinontrine is a highly selective
and potent small molecule inhibitor of phosphodiesterase-9 (PDE9).
Tovinontrine has a multimodal mechanism of action that acts
primarily on red blood cells, or RBCs, and has the potential to act
on white blood cells, or WBCs, adhesion mediators and other cell
types. PDE9 selectively degrades cyclic guanosine monophosphate
(cGMP), an active signaling molecule that plays a role in vascular
biology and hemoglobin production on RBCs. Lower levels of cGMP are
found in people with sickle cell disease (SCD) and
beta-thalassemia. Blocking PDE9 acts to increase cGMP levels, which
is associated with lower WBC activation and reduced adhesion across
various cell types, both of which also contribute to SCD, including
the occurrence of vaso-occlusive crises (VOCs). Increasing cGMP
levels is also associated with several additional benefits
including the potential reactivation of fetal hemoglobin (HbF), a
natural hemoglobin produced during fetal development. Increased
levels of HbF in RBCs have been demonstrated to improve
symptomology and substantially lower disease burden in both
patients with SCD and patients with beta-thalassemia.
About Imara Imara Inc. is a clinical-stage biotechnology company
dedicated to developing and commercializing novel therapeutics to
treat patients suffering from rare inherited genetic disorders of
hemoglobin and other serious diseases. Imara is advancing
tovinontrine (IMR-687), a highly selective, potent small molecule
inhibitor of PDE9 that is an oral, potentially disease-modifying
treatment currently in clinical development for sickle cell disease
and beta-thalassemia and preclinical development for heart failure
with preserved ejection fraction, or HFpEF. Imara is also advancing
IMR-261, an oral activator of nuclear factor erythroid 2-related
factor 2, or Nrf2. For more information, please visit
www.imaratx.com.
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