Imara Inc. (Nasdaq: IMRA), a clinical-stage biopharmaceutical
company dedicated to developing and commercializing novel
therapeutics to treat patients suffering from rare inherited
genetic disorders of hemoglobin, today announced the presentation
of data from the Phase 2a clinical trial and its open label
extension (OLE) trial of IMR-687 in adults with sickle cell disease
(SCD) at the European Hematology Association (EHA) Annual Congress,
being held virtually June 9-17, 2021.
“The impact of IMR-687 on several VOC-related parameters is
potentially an exciting development for the treatment of sickle
cell disease,” said Biree Andemariam, M.D., Associate Professor at
UConn School of Medicine, Director of the New England Sickle Cell
Institute at UConn Health, and lead investigator for the Phase 2a
clinical trial. “These data include lower annualized VOC rates,
fewer VOC-related hospitalizations, increased time to first VOC,
and improvements in patient-reported VOC pain severity score. VOCs
and associated pain are a leading cause of emergency room visits
and morbidity in SCD and as result, a meaningful measure of
clinical benefit to this patient community.”
“The VOC data in our 93-patient Phase 2a clinical trial point to
a potential multimodal mechanism-of-action of IMR-687 in sickle
cell disease that acts primarily on red blood cells and has the
potential to act on white blood cells, adhesion mediators and other
cell types. In addition, it is encouraging to see that patients in
the OLE clinical trial are continuing to benefit from lower
annualized VOC rates for an additional eight months, extending the
results seen in the six-month Phase 2a trial,” said Rahul Ballal,
Ph.D., President and Chief Executive Officer of Imara. “These
clinical outcome data have also prompted us to elevate annualized
VOC rates to the key secondary endpoint in the ongoing Ardent Phase
2b clinical trial. We look forward to engaging the FDA in the
coming months on these two datasets.”
Dr. Ballal continued, “We are also pleased that 36% (4/11) of
patients in the OLE clinical trial had absolute HbF increases of
more than 3% at the eight-month timepoint while receiving a 200 mg
dose of IMR-687. We believe that higher doses of IMR-687 have the
potential to show even more robust HbF increases. The Ardent Phase
2b clinical trial, currently dosing up to 400 mg daily, is powered
to show an absolute HbF increase at Week 24 of at least 3% in 35%
of subjects on IMR-687 versus 5% on placebo. We look forward to
reporting interim data from both the Ardent Phase 2b clinical trial
in patients with sickle cell disease and the Forte Phase 2b
clinical trial in patients with beta-thalassemia later this
year.”
Phase 2a Data Highlights (n=93):The Phase 2a
clinical trial evaluated the safety, tolerability, PK and
exploratory PD and clinical outcomes of IMR-687 in 93 adults with
SCD. Final results for this trial indicate a well-tolerated safety
profile, lower VOC rates, improved patient reported pain severity
score, and variable biomarker results, including with respect to
fetal hemoglobin (HbF).
- VOC results for all 93 subjects enrolled:
- 40% lower mean annualized VOC rate in IMR-687-treated groups
versus placebo groups with a significant difference between the
median values of zero per year in IMR-687-treated groups versus
1.87 per year in placebo groups
- Significant increase in time to first VOC of 169 days for
IMR-687-treated groups versus 87 days for placebo groups
- Lower mean annualized rate of VOC-related hospitalizations of
0.84 per year in IMR-687-treated groups versus 1.36 per year in
placebo groups
- Mean annualized VOC rate was also lower in those subjects on
IMR-687 + background hydroxyurea (HU) versus placebo + HU
- Improved patient-reported outcomes regarding severity of pain
episodes (ASCQ-Me) for patients in IMR-687 100/200 mg group as
compared to placebo groups
- Significant mean increase in F-cells in pooled IMR-687-treated
groups versus placebo groups; increases in F-cells were correlated
with HbF and with increased IMR-687 exposure
OLE Data Highlights (n=24):Imara
is conducting a four-year OLE clinical trial which allows
patients to enroll in a long-term safety and tolerability study of
IMR-687 following completion of the Phase 2a clinical trial.
Updated interim data from the ongoing OLE trial in 24 adults with
SCD showed IMR-687 continued to be well-tolerated. Improvements in
VOC rates observed in the Phase 2a clinical trial were maintained
and improvements in HbF and F-cells were seen in OLE clinical trial
subjects with data available at eight months or longer.
- The low mean annualized VOC rate for IMR-687-treated patients
in the Phase 2a clinical trial was maintained in patients who
remained on IMR-687 in the OLE clinical trial (N=13), with mean
annualized VOC rates of 1.3 (Phase 2a) and 1.8 (OLE) per year
- The mean annualized VOC rate was reduced by 39% in subjects
previously in the placebo group in the Phase 2a clinical trial
(N=5), with mean annualized VOC rates of 4.7 (Phase 2a) and 2.9
(OLE) per year.
- 36% (4/11) of patients had absolute HbF increases ≥3% with a
mean absolute increase of 1.7%; 47% (7/15) of patients had absolute
F-cell increases of ≥6% with a mean absolute increase of 6.8%;
variable results with respect to other biomarkers. The two patients
previously documented as part of case narratives and with the
longest duration of therapy in the OLE trial, have shown persistent
increases in F-cells and HbF of greater than 3% through 12-24
months, along with reductions in selected biomarkers of RBC
hemolysis.
Safety Summary:IMR-687 was well-tolerated in
monotherapy and in combination with HU in each of the Phase 2a and
OLE clinical trials; the most frequent adverse events (≥20% in one
or more IMR-687 group) included headache and nausea. There were no
treatment-related serious adverse events or treatment related Grade
3 or greater adverse events in the IMR-687-treated groups. There
were no clinically significant changes in laboratory safety data,
electrocardiogram (ECG) or vital signs, and no cases of neutropenia
were observed.
Presentation at European Hematology Association (EHA)
Annual Congress:Title: The Safety,
Pharmacokinetics & Pharmacodynamic Effects of IMR-687, a
Highly-Selective PDE9 Inhibitor, In Adults with Sickle Cell
Disease: Phase-2A Placebo-Controlled & Open-Label Extension
StudiesLive Q&A Session Date and Time:
Tuesday, June 15, 2021, from 10:00 - 10:45 a.m. ET (4:00 - 4:45
p.m. CEST)Oral Abstract Session: Changing the
scene on sickle cell diseaseAbstract:
S263Presenter: Biree Andemariam, M.D., Associate
Professor at UConn School of Medicine and Director of the New
England Sickle Cell Institute at UConn Health
The oral presentation can be accessed on demand by registered
meeting attendees on the EHA Virtual Congress platform as
of Friday, June 11 at 3:00 a.m. ET (9:00 a.m.
CEST) and a copy of the presentation will also be available on
the Investors section of the Imara website.
Conference Call InformationImara will host a
conference call and live webcast today at 8:00 a.m. ET. The live
webcast will be available under “Events and Presentations” in the
Investors section of the company's website. The conference call can
be accessed by dialing 1 (833) 519-1307 (U.S. domestic) or +1 (914)
800-3873 (international) and referring to conference ID 6979424. A
replay of the webcast will be archived on the Imara website
following the presentation.
About IMR-687IMR-687 is a highly selective and
potent small molecule inhibitor of PDE9. PDE9 uniquely degrades
cyclic guanosine monophosphate (cGMP), an active signaling molecule
that plays a role in vascular biology. Lower levels of cGMP are
often found in people with sickle cell disease and beta-thalassemia
and are associated with impaired blood flow, increased
inflammation, greater cell adhesion and reduced nitric
oxide-mediated vasodilation.
Blocking PDE9 acts to increase cGMP levels, which are associated
with reactivation of fetal hemoglobin, or HbF, a natural hemoglobin
produced during fetal development. Increased levels of HbF in red
blood cells have been demonstrated to improve symptomology and
lower disease burden in patients with sickle cell disease and
patients with beta-thalassemia. IMR-687 is designed to have a
multimodal mechanism of action that acts on red blood cells, white
blood cells, adhesion mediators, and other cell types.
About ImaraImara 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. Imara is currently advancing
IMR-687, a highly selective, potent small molecule inhibitor of
PDE9 that is an oral, once-a-day, potentially disease-modifying
treatment for sickle cell disease and beta-thalassemia. IMR-687 is
being designed to have a multimodal mechanism of action that acts
on red blood cells, white blood cells, adhesion mediators and other
cell types. For more information, please
visit www.imaratx.com.
Cautionary Note Regarding Forward-Looking
StatementsStatements in this press release about future
expectations, plans and prospects, as well as any other statements
regarding matters that are not historical facts, may constitute
“forward-looking statements” within the meaning of The Private
Securities Litigation Reform Act of 1995. These statements include,
but are not limited to, statements relating to the (i) clinical
trial design and timing with respect to reporting of data from the
Ardent and Forte Phase 2b clinical trials in patients with sickle
cell disease and beta-thalassemia, (ii) timing and plan to engage
the FDA with regards to the Phase 2a clinical trial and OLE
clinical trial data and (iii) the Company’s beliefs regarding the
strength of its clinical data, the tolerability and therapeutic
potential of IMR-687 and advancement of its clinical program. The
words “anticipate,” “believe,” “continue,” “could,” “estimate,”
“expect,” “intend,” “may,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “will,” “would” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors, including the impact of extraordinary external
events, such as the risks and uncertainties resulting from the
impact of the COVID-19 pandemic on the Company’s business,
operations, strategy, goals and anticipated milestones, including
its ongoing and planned research activities and ability to conduct
and readout data from its ongoing clinical trials of IMR-687; the
Company’s ability to advance the development of IMR-687 under the
timelines it projects in current and future clinical trials,
demonstrate in any current and future clinical trials the requisite
safety and efficacy of IMR-687, replicate scientific and
non-clinical data in both subsequent case report readouts and in
clinical trials and other factors discussed in the “Risk Factors”
section of the Company’s most recent Quarterly Report on Form 10-Q,
which is on file with the Securities and Exchange Commission and in
other filings that the Company makes with the Securities and
Exchange Commission in the future. Any forward-looking statements
contained in this press release speak only as of the date hereof,
and the Company expressly disclaims any obligation to update any
forward-looking statement, whether as a result of new information,
future events or otherwise.
Media Contact:Marin BergmanTen Bridge
Communications818-516-2746Marin@tenbridgecommunications.com
Investor Contact:Michael
Gray617-835-4061mgray@imaratx.com
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