Arix Bioscience PLC (ARIX) Imara Announces Results of Interim
Analyses of Tovinontrine (IMR-687) Phase 2b Clinical Trials in
Sickle Cell Disease and Beta-Thalassemia 05-Apr-2022 / 16:28
GMT/BST Dissemination of a Regulatory Announcement, transmitted by
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PRESS RELEASE
Arix Bioscience plc
Imara Announces Results of Interim Analyses of Tovinontrine
(IMR-687) Phase 2b Clinical Trials in Sickle Cell Disease and
Beta-Thalassemia
LONDON, 05 April 2022: Arix Bioscience plc ("Arix", LSE:ARIX), a
global venture capital company focused on investing in breakthrough
biotechnology companies, notes that its portfolio company, Imara
Inc. (Nasdaq: IMRA), today announced results from interim analyses
of its Ardent Phase 2b clinical trial of tovinontrine (IMR-687) in
patients with sickle cell disease (SCD) and Forte Phase 2b clinical
trial of tovinontrine in patients with beta-thalassemia. Imara also
announced that because of the data generated by these interim
analyses, the company will discontinue the Ardent and Forte trials
as well as the further development of tovinontrine in sickle cell
disease and beta-thalassemia.
As of close of business on 4 April 2022 Arix held 2,344,072
shares in Imara.
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 ANNOUNCES RESULTS OF INTERIM ANALYSES OF TOVINONTRINE
(IMR-687) PHASE 2B CLINICAL TRIALS IN SICKLE CELL DISEASE AND
BETA-THALASSEMIA
April 5, 2022 at 6:45 AM EDT
Interim results in Ardent trial for sickle cell disease showed
no significant difference in median annualized rate of
vaso-occlusive crises in high-dose group versus placebo in an
intent-to-treat population
Interim results in Forte trial for beta-thalassemia demonstrated
no meaningful benefit in transfusion burden or improvement in most
disease-related biomarkers
Tovinontrine was generally well-tolerated across studies
Both Phase 2b clinical trials and further development of
tovinontrine in sickle cell and beta-thalassemia to be
discontinued
BOSTON, April 05, 2022 (GLOBE NEWSWIRE) -- Imara Inc. (Nasdaq:
IMRA) today announced results from interim analyses of its Ardent
Phase 2b clinical trial of tovinontrine (IMR-687) in patients with
sickle cell disease (SCD) and Forte Phase 2b clinical trial of
tovinontrine in patients with beta-thalassemia. Imara also
announced that because of the data generated by these interim
analyses, the company will discontinue the Ardent and Forte trials
as well as the further development of tovinontrine in sickle cell
disease and beta-thalassemia.
"We are disappointed in the outcome of both of the interim
analyses in our Phase 2b studies for sickle cell disease and
beta-thalassemia, and particularly that the Ardent trial interim
analysis did not replicate our previously observed positive
vaso-occlusive crisis data," said Rahul Ballal, Ph.D., President
and Chief Executive Officer of Imara. "We plan to discontinue both
studies during the second quarter. As we do this, we remain deeply
grateful to the patients, investigators and their teams for their
participation in these trials and to the extended Imara team for
their role and dedication in generating the comprehensive interim
results."
Dr. Ballal continued, "Moving forward, we plan to consider our
strategic options, including development of tovinontrine in heart
failure with preserved ejection fraction (HFpEF) as well IMR-261
clinical development plans."
Ardent Phase 2b Sickle Cell Disease Interim Analysis: The
interim analysis for the Ardent trial was conducted when all
participants completed the week 24 assessment or terminated early.
The intent-to-treat (ITT) population was used for the primary
efficacy analysis, which is a comparison of the median annualized
vaso-occlusive crisis (VOC) rate between the high dose tovinontrine
group (n=47, once daily oral dose of 300 mg or 400 mg based on
patient weight) and placebo group (n=32).
Safety was analyzed across all participants enrolled in the
Ardent trial, including the high dose, low dose (n=33, 200 mg or
300 mg once daily oral dose based on patient weight) and placebo
groups. Data from the interim analysis demonstrated that
tovinontrine was generally well-tolerated, with the most frequent
adverse events (>=10% of participants in any treatment group)
considered at least possibly related to study drug by the
investigator being nausea, headache, dizziness and vomiting. Four
(3.6%) participants discontinued prior to week 24 due to adverse
events.
The median annualized VOC rate in the placebo group was 2.02
VOCs per year and was 1.89 VOCs per year in the high dose
tovinontrine group, for a treatment difference of 0.13 VOCs per
year, or 6.4%. Based on the minimal decrease observed in VOCs with
the high dose and low VOC rate in the placebo arm, Imara enacted an
addendum to the statistical analysis plan for the trial and noted
trends of VOC benefit with tovinontrine. The median annualized rate
of VOCs in the low dose tovinontrine group was zero, as compared to
2.02 in the placebo group, and as compared to placebo, the low dose
tovinontrine group experienced an increase in median time to first
VOC and a higher proportion of participants who were VOC-free. A
trend for lower median annualized rate of VOCs was also observed
for participants in the high and low dose tovinontrine groups on
monotherapy (not on background hydroxyurea) as compared to placebo.
Although these additional data are encouraging, none were
statistically significant. In addition, no meaningful difference
was observed in fetal hemoglobin (HbF) response in either the high
or low dose tovinontrine groups as compared to placebo.
Collectively, the overall additional data did not materially
increase the likelihood of success for this trial.
Forte Phase 2b Beta-thalassemia Interim Analysis: The Forte
trial interim analysis evaluated safety and biomarker data for both
transfusion-dependent thalassemia (TDT) and
non-transfusion-dependent thalassemia (NTDT) cohorts, as well as
data on transfusion burden reduction in the TDT cohort. In both
cohorts, tovinontrine was well-tolerated, with the most frequent
adverse events (>=10% of participants in any treatment group)
considered at least possibly related to study drug by the
investigator being nausea and headache. One NTDT and eight TDT
participants (3.3% and 10.8%, respectively) discontinued study drug
due to adverse events.
Participants in the TDT cohort of the Forte trial were
randomized to either placebo (n=20), low dose (n=25, 200 mg or 300
mg) or high dose (n=29, 300 mg or 400 mg). No meaningful benefit
was observed in transfusion burden in either tovinontrine group
when compared to placebo. Participants in the NTDT cohort of the
Forte trial were randomized to either placebo (n=7), low-dose group
(n=8, 200 mg or 300 mg), or high-dose group (n=14, 300 mg or 400
mg). No meaningful improvements were observed in most
disease-related biomarkers, including total hemoglobin (Hb).
About the Ardent Phase 2b Clinical Trial The Ardent study was a
randomized, double-blind, placebo-controlled, multicenter Phase 2b
study in adult patients with sickle cell disease (SCD) randomized
to either placebo, low-dose tovinontrine (200 mg or 300 mg) or
high-dose tovinontrine (300 mg or 400 mg). The primary efficacy
endpoint was annualized rate of VOCs in participants dosed with
high dose tovinontrine as compared to placebo. The key secondary
endpoints were time to first VOC and proportion of participants
with fetal hemoglobin (HbF) response, defined as an absolute
increase from baseline of at least 3% in HbF in the high dose group
vs placebo.
About the Forte Phase 2b Clinical Trial The Forte study was a
randomized, double-blind, placebo-controlled, multicenter Phase 2b
clinical trial evaluating the safety and tolerability of
tovinontrine in adult patients with beta-thalassemia. Patient
randomization was stratified by transfusion-dependent thalassemia
(TDT) or non-transfusion-dependent thalassemia (NTDT). The primary
objective of the study was safety and tolerability. For TDT
participants, the clinical trial also evaluated the effect of
tovinontrine versus placebo in reducing transfusion burden. For
NTDT participants, the clinical trial also evaluated the effect of
tovinontrine versus placebo on fetal hemoglobin as well as total
hemoglobin.
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 on red
blood cells, white blood cells, adhesion molecules and blood
vessels. PDE9 selectively degrades cyclic guanosine monophosphate
(cGMP), an active signaling molecule that plays a role in vascular
biology.
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