Arix Bioscience PLC (ARIX) Imara Announces Interim Analysis Data
From Forte Phase 2b Clinical Trial Of Tovinontrine (Imr-687) In
Transfusion-Dependent Subjects With Beta-Thalassemia 17-Nov-2021 /
17:04 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 Announces Interim Analysis Data From Forte Phase 2b
Clinical Trial Of Tovinontrine (Imr-687) In Transfusion-Dependent
Subjects With Beta-Thalassemia
LONDON, 17 November 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, has announced data from a pre-specified interim analysis
from its ongoing Forte Phase 2b clinical trial of tovinontrine
(IMR-687) in transfusion-dependent subjects (TDT) with
beta-thalassemia.
Imara observed a positive trend in transfusion-dependent
subjects treated with higher dose tovinontrine for reduced
transfusion burden and that tovinontrine was generally
well-tolerated in this patient population.
Additional data will be presented as part of a key efficacy
analysis expected 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
Optimum Strategic Communications
Mary Clark, Manel Mateus
+44 (0)20 3922 1906
optimum.arix@optimumcomms.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 ANNOUNCES INTERIM ANALYSIS DATA FROM FORTE PHASE 2B
CLINICAL TRIAL OF TOVINONTRINE (IMR-687) IN TRANSFUSION-DEPENDENT
SUBJECTS WITH BETA-THALASSEMIA
-- Positive trend observed in transfusion-dependent subjects
treated with higher dose tovinontrine forreduced transfusion
burden
-- Tovinontrine was generally well-tolerated in this patient
population
BOSTON, Nov. 16, 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 data from a pre-specified
interim analysis from its ongoing Forte Phase 2b clinical trial of
tovinontrine (IMR-687) in transfusion-dependent subjects (TDT) with
beta-thalassemia.
"Today's announcement of the first clinical data exploring
tovinontrine's potential in transfusion-dependent patients with
beta-thalassemia marks an important milestone for Imara and
patients with beta-thalassemia seeking oral therapies," said Rahul
Ballal, Ph.D., President and Chief Executive Officer of Imara. "We
are encouraged by the positive trend for transfusion burden
reduction at the higher dose of tovinontrine. Furthermore, we are
pleased that the interim data continue to demonstrate a favorable
safety and tolerability profile at doses of tovinontrine up to 400
mg once daily. We look forward to a key efficacy analysis, which we
expect will occur in the first quarter of 2022, with more subjects
treated through 24 weeks. In addition, we are continuing to advance
enrollment in the non-transfusion-dependent (NTDT) cohort of the
trial and expect to report initial NTDT data in the first half of
2022."
Highlights of the Forte Phase 2b Interim Analysis
Subjects in the Forte trial were randomized to either a lower
dose group (200 mg or 300 mg), higher dose group (300 mg or 400
mg), or placebo, utilizing a pre-defined weight gate. Of the 43 TDT
subjects in this interim dataset, 35 completed at least 12 weeks of
treatment and were in the analysis population for transfusion
burden. Safety data through week 24 from higher and lower dose
groups were pooled for this interim analysis to prevent unblinding
of the study. The median baseline transfusion burden in each of the
higher dose tovinontrine and placebo groups was 7.5 red blood cell
(RBC) units/12 weeks. Furthermore, 54% of the subjects in the
analysis population (19/35) had the more severe ?0/?0 genotype.
Interim data from the Forte study demonstrated tovinontrine was
well-tolerated, with the most frequent adverse events (>=10% of
subjects in pooled tovinontrine dose groups) being nausea, headache
and dizziness. Four (9.3%) subjects discontinued due to adverse
events considered at least possibly related to study drug.
The proportion of subjects who had a >=33% reduction in
transfusion burden (of at least 2 units) in any 12-week interval as
compared to the 12-week interval prior to randomization was greater
in the higher dose tovinontrine group (7/8) versus placebo, despite
an unexpectedly high response rate in the placebo group (8/12).
Lower dose tovinontrine did not show a higher response rate when
compared to the placebo group. No substantial differences between
groups were observed in transfusion burden response rate using a
fixed interval (weeks 13-24). Red blood cell markers are not
evaluable in these regularly transfused subjects. Additional data
will be presented as part of a key efficacy analysis expected in
the first quarter of 2022.
About the Forte Phase 2b Clinical Trial
The Forte study is a 9-month, global, randomized, double-blind,
placebo-controlled, multicenter Phase 2b clinical trial evaluating
the safety and tolerability of tovinontrine (IMR-687) in
approximately 120 adult subjects with beta-thalassemia. Patient
randomization is stratified by transfusion-dependent thalassemia
(TDT) or non-transfusion-dependent thalassemia (NTDT). The primary
objective of the study is safety and tolerability. For TDT
subjects, the clinical trial is evaluating the effect of
tovinontrine versus placebo in reducing transfusion burden. For
NTDT subjects, the clinical trial is evaluating the effect of
tovinontrine versus placebo on fetal hemoglobin as well as total
hemoglobin. For more information about the Forte trial visit
https://www.clinicaltrials.gov/ct2/show/ NCT04411082.
The U.S. Food and Drug Administration (FDA) has granted Orphan
Drug, Fast Track and Rare Pediatric Disease designations for
tovinontrine for the treatment of beta-thalassemia.
About Tovinontrine (IMR-687)
Tovinontrine is a highly selective and potent small molecule
inhibitor of phosphodiesterase-9 (PDE9). PDE9 selectively degrades
cyclic guanosine monophosphate (cGMP), an active signaling molecule
that plays a role in vascular biology and hemoglobin production in
red blood cells. Lower levels of cGMP are found in people with
sickle cell disease (SCD) and beta-thalassemia and are associated
with reduced blood flow, increased inflammation, greater cell
adhesion and reduced nitric oxide mediated vasodilation. Blocking
PDE9 acts to increase cGMP levels, which is associated with a
number of 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 Beta-Thalassemia
Beta-thalassemia, a hemoglobinopathy, is a rare inherited red
blood cell disorder. The disease can lead to severe anemia,
splenomegaly, skeletal abnormalities and iron overload leading to
organ failure and early death. The prevalence of beta-thalassemia
globally is estimated to be approximately 288,000, with an
incidence of 60,000 births per year, and it is especially prevalent
in northern Africa, South Asia, Southeast Asia, the Mediterranean
region and the Middle East. The total combined prevalence of beta
thalassemia in the European Union and United States is estimated to
be approximately 19,000 patients.
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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ISIN: GB00BD045071
Category Code: MSCM
TIDM: ARIX
LEI Code: 213800OVT3AHQCXNIX43
OAM Categories: 3.1. Additional regulated information required to be disclosed under the laws of a Member State
Sequence No.: 127093
EQS News ID: 1249991
End of Announcement EQS News Service
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