IMRA IMARA Inc.

12.59
+0.09  (+1%)
Previous Close 12.5
Open 12.58
52 Week Low 11.85
52 Week High 62.71
Market Cap $219,159,682
Shares 17,407,441
Float 7,709,052
Enterprise Value $128,466,988
Volume 77,650
Av. Daily Volume 145,378
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Upcoming Catalysts

Drug Stage Catalyst Date
IMR-687
b-thalassemia
Phase 2b
Phase 2b
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IMR-687 (Ardent)
Sickle cell disease (SCD)
Phase 2b
Phase 2b
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Drug Pipeline

Drug Stage Notes
IMR-687
Sickle cell disease
Phase 2a
Phase 2a
Phase 2a data released January 6, 2021. Biomarker results showed no meaningful changes in F-cells, fetal hemoglobin (HbF) levels, or Hb levels from baseline through week 24 in monotherapy arm. In combo arm an overall increase in F-cells and HbF levels from baseline to week 24 was shown, but Hb levels did not meaningfully change.

Latest News

  1. BOSTON, Feb. 26, 2021 (GLOBE NEWSWIRE) -- 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 that the company will host a conference call and live webcast on Friday, March 5, 2021 at 8:30 a.m. ET to discuss its financial results for the year ended December 31, 2020 and review recent business highlights.

    A 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 (914) 800-3873 (international) and referring to conference ID 1368162…

    BOSTON, Feb. 26, 2021 (GLOBE NEWSWIRE) -- 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 that the company will host a conference call and live webcast on Friday, March 5, 2021 at 8:30 a.m. ET to discuss its financial results for the year ended December 31, 2020 and review recent business highlights.

    A 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 (914) 800-3873 (international) and referring to conference ID 1368162. A replay of the webcast will be archived on the Imara website following the presentation.

    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. 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

    Media Contact:

    Gina Nugent

    Ten Bridge Communications

    617-460-3579



    Investor Contact:

    Michael Gray

    617-835-4061



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  2. BOSTON, Feb. 19, 2021 (GLOBE NEWSWIRE) -- 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 that Rahul Ballal, Ph.D., President and Chief Executive Officer, will participate in a Fireside Chat at the SVB Leerink 10th Annual Global Healthcare Conference on Friday, February 26, from 1:40-2:10 p.m. ET. 

    A replay of the webcast will be archived on the "Events and Presentations" section of Imara's website

    About Imara
    Imara Inc. is a clinical-stage biotechnology company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare…

    BOSTON, Feb. 19, 2021 (GLOBE NEWSWIRE) -- 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 that Rahul Ballal, Ph.D., President and Chief Executive Officer, will participate in a Fireside Chat at the SVB Leerink 10th Annual Global Healthcare Conference on Friday, February 26, from 1:40-2:10 p.m. ET. 

    A replay of the webcast will be archived on the "Events and Presentations" section of Imara's website

    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. 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.

    Media Contact:

    Gina Nugent

    Ten Bridge Communications

    617-460-3579

    Investor Contact:

    Michael Gray

    617-835-4061

     



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  3. BOSTON, Jan. 20, 2021 (GLOBE NEWSWIRE) -- 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 appointment of Kenneth Attie, M.D. as Senior Vice President and Chief Medical Officer. Dr. Attie joins Imara with over 30 years of experience within academia and the biopharmaceutical industry, most recently at Acceleron Pharma, Inc. where he led global clinical development efforts that led to the recent FDA and EMA approvals of a new treatment for patients with rare anemias, including beta-thalassemia. 

    "We are excited to have the benefit of Ken's global medical experience…

    BOSTON, Jan. 20, 2021 (GLOBE NEWSWIRE) -- 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 appointment of Kenneth Attie, M.D. as Senior Vice President and Chief Medical Officer. Dr. Attie joins Imara with over 30 years of experience within academia and the biopharmaceutical industry, most recently at Acceleron Pharma, Inc. where he led global clinical development efforts that led to the recent FDA and EMA approvals of a new treatment for patients with rare anemias, including beta-thalassemia. 

    "We are excited to have the benefit of Ken's global medical experience as we continue to advance IMR-687 in multiple clinical studies worldwide," said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara. "Ken's deep expertise in rare anemias and disorders of hemoglobin, combined with his established clinical management experience, will be a great addition to our leadership team."

    "I am excited to be part of the Imara team as we move closer toward our goal of providing novel and accessible treatments for patients suffering from hemoglobinopathies, including sickle cell disease and beta-thalassemia," commented Dr. Attie. "I look forward to providing medical leadership as Imara continues to advance IMR-687 in its ongoing global Phase 2b trials in those indications, as well as in potential future indications amenable to PDE9 inhibition, such as heart failure with preserved ejection fracture."

    Prior to joining Imara, Dr. Attie served as Vice President of Medical Research at Acceleron Pharma for more than ten years. In this role, he managed clinical studies with several investigational drugs involving TGF-beta superfamily pathways in rare anemias, malignancies, and neuromuscular disorders, leading to regulatory approval of Reblozyl® for patients with transfusion-dependent beta-thalassemia and certain myelodysplastic syndromes. Before Acceleron, Dr. Attie held clinical development and medical affairs leadership roles of increasing responsibility at Altus Pharmaceuticals, Insmed, Inc. and Genentech, Inc. His work in the field of growth hormone and related growth factors contributed to the approval of therapies in numerous indications, including pediatric and adult GH deficiency, chronic renal insufficiency, Turner syndrome, idiopathic short stature and primary IGF-1 deficiency. Dr. Attie, a board-certified pediatric endocrinologist with over 55 publications in peer-reviewed journals, was a visiting professor at the State Institute for Diabetes and Endocrinology in Rio de Janeiro and an assistant clinical professor in the Department of Pediatric Endocrinology at the University of California, San Francisco. He received his education and medical training at the University of Michigan, Ann Arbor, New York University Medical Center, and University of California, San Francisco Medical Center.

    About IMR-687

    IMR-687 is a highly selective and potent small molecule inhibitor of PDE9. PDE9 selectively degrades cyclic guanosine monophosphate (cGMP), an active signaling molecule that plays a role in vascular biology. Lower levels of cGMP are found in people with 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 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. 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 Statements

    Statements 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 Company's plans, strategies and prospects. 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 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 specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

    Media Contact:

    Gina Nugent

    Ten Bridge Communications

    617-460-3579

    tions.com

    Investor Contact:

    Michael Gray

    617-835-4061 



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  4. Promising reductions in rate of VOCs/SCPCs observed in monotherapy IMR-687 treated patients vs. placebo

    Biomarker data from both monotherapy IMR-687 and combination IMR-687+HU groups show improvement in markers of hemolysis with variable HbF results

    Reductions in hsCRP and NTproBNP in monotherapy IMR-687 treated patients suggest potential for lowering inflammation and cardiac stress in SCD

    IMR-687 was well tolerated as a monotherapy and in combination with hydroxyurea

    Additional data from Phase 2a open label extension trial and interim results from Ardent and Forte Phase 2b clinical trials expected in 2021

    BOSTON, Jan. 06, 2021 (GLOBE NEWSWIRE) -- Imara Inc. (NASDAQ:IMRA), a clinical-stage biopharmaceutical company dedicated to developing…

    Promising reductions in rate of VOCs/SCPCs observed in monotherapy IMR-687 treated patients vs. placebo

    Biomarker data from both monotherapy IMR-687 and combination IMR-687+HU groups show improvement in markers of hemolysis with variable HbF results

    Reductions in hsCRP and NTproBNP in monotherapy IMR-687 treated patients suggest potential for lowering inflammation and cardiac stress in SCD

    IMR-687 was well tolerated as a monotherapy and in combination with hydroxyurea

    Additional data from Phase 2a open label extension trial and interim results from Ardent and Forte Phase 2b clinical trials expected in 2021

    BOSTON, Jan. 06, 2021 (GLOBE NEWSWIRE) -- 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 (Hb), today reported results from its Phase 2a clinical trial of IMR-687 in adult patients with sickle cell disease (SCD).

    "I am encouraged by the incremental data from this readout, especially in light of the COVID-19 pandemic challenges," 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 trial. "This includes a favorable safety profile of IMR-687, lower rate of VOCs/SCPCs and VOC-related hospitalizations in the Population A1 monotherapy arm and improvements in several biomarker results across both the monotherapy and combination groups. I am also pleased by the reductions in hsCRP and NT-proBNP in the Population A1 monotherapy arm. Both are clinically utilized biomarkers of inflammation and cardiac stress, respectively, and suggest that higher doses of IMR-687 may have novel anti-inflammatory and cardiovascular benefits in sickle cell disease."

    "I would like to thank the patients, sickle cell disease community, and healthcare providers for their participation in this trial, particularly because the COVID-19 pandemic reduced access to clinical centers," said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara. "These incremental Phase 2a results start an important year of data readouts at Imara. In the first quarter of 2021, we plan to report updates from our Phase 2a open label extension trial, including results on 10-15 patients. In the second half of 2021, we expect to report interim data from our ongoing higher dose Ardent and Forte Phase 2b clinical trials in sickle cell disease and beta-thalassemia, respectively."

    The Phase 2a clinical trial included a total of 93 treated patients across four different sub-studies and was designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and clinical outcomes of escalating doses of IMR-687 administered once daily for 16 to 24 weeks, either as a monotherapy or in combination with hydroxyurea (HU). Overall, the data from the Phase 2a clinical trial demonstrated that IMR-687 was well tolerated as a monotherapy and in combination with HU at all dose levels. There were no observed clinically significant shifts in vital signs or electrocardiogram data, including no hypotension or neutropenia in either the monotherapy or combination arms. Interim data on patients from Populations A and B were previously disclosed, with results from the A1 and B1 populations being reported for the first time.

    Monotherapy Sub-studies (A/A1):

    Population A (n=40): Patients received either placebo or IMR-687 at once-daily doses of 50 mg or 100 mg through 12 weeks and then higher doses of 100 mg or 200 mg, respectively, through an additional 12 weeks (24 weeks total).

    Population A1 (n=18): Patients received either placebo or IMR-687 at a once-daily dose of 100 mg through 4 weeks and then 200 mg through an additional 20 weeks (24 weeks total).

    Combination Sub-studies (B/B1):

    Population B (n=21): Patients received either placebo or IMR-687 once-daily at 50 mg on top of a stable dose of standard of care HU, with escalation after 4 weeks to 100 mg for an additional 12 weeks (16 weeks total).

    Population B1 (n=14): Patients received either placebo or IMR-687 once-daily at 50 mg on top of a stable dose of standard of care HU, with escalation after 4 weeks to 100 mg for an additional 20 weeks (24 weeks total).

    Population A1 (monotherapy)

    The most frequent adverse events in the IMR-687 treatment arm included sickle cell anemia with crisis, nausea, headache and back pain and were generally consistent with those observed at two previously reported interim analyses. A 25% lower rate of vaso-occlusive crises/sickle cell-related pain crises (VOCs/SCPCs), as part of the safety analysis, was observed in the IMR-687 treatment group when compared to placebo. 58% of patients (7 of 12, 9 events total) experienced at least one VOC/SCPC in the IMR-687 treatment group as compared to 83% (5 of 6, 14 events total) in the placebo population. Furthermore, the rate of VOC-related hospitalizations was lower in the IMR-687 treatment group when compared to placebo. 33% of patients (4 of 12) experienced one VOC-related hospitalization in the IMR-687 treatment group as compared to 66% (4 of 6) in the placebo population.

    Biomarker results showed no meaningful changes in F-cells, fetal hemoglobin (HbF) levels, or Hb levels from baseline through week 24. However, a dose-dependent increase in HbF (1.3% absolute increase) was seen when patients dose escalated from 100 mg to 200 mg, starting after 4 weeks and through 24 weeks. One of seven evaluable patients (14%) in Population A1 recorded an absolute increase in HbF percentage from baseline of greater than 1% (increase of 3.2%). Markers of hemolysis that include percent reticulocytes, absolute reticulocyte count, indirect bilirubin and LDH all improved from baseline in a dose dependent manner, with the greatest improvement occurring when patients were on the 200 mg dose. This trend similarly occurred with high sensitivity C-reactive protein (hsCRP) and amino-terminal pro-brain type natriuretic peptide (NT-proBNP) values. Placebo patients from Population A1 did not have evaluable week 24 PD biomarker results due in part to missing study visits and are therefore not included in the table below. A summary of the mean results from the IMR-687 treatment arm are as follows:

    MeasureBaseline

    Value
    Week 24

    Value
    Percent Change from

    Baseline to Week 24
    HbF percentage (%)8.88.7-1.1%
    F-cell percentage (%)28.128.51.4%
    Hb (g/dL)8.88.6-2.3%
    Markers of Hemolysis
    Percent reticulocytes (%)10.47.4-28.8%
    Absolute reticulocyte count (×109/L)296240-18.9%
    Indirect bilirubin (µmol/L)61.444.0-28.3%
    LDH (IU/L)397346-12.8%
    Markers of Inflammation & Cardiac Stress
    hsCRP (mg/L)10.42.5-75.9%
    NTproBNP (ng/L)685414-39.6%

    Population B1 (combination therapy)

    The most frequent adverse events in the IMR-687+HU treatment arm included headache, sickle cell anemia with crisis and nausea and were generally consistent with those observed in Population A1. There were no meaningful differences in VOCs/SCPCs or VOC related hospitalizations, between the IMR-687+HU and HU+placebo groups.

    Biomarker results in IMR-687+HU treated patients showed an overall increase in F-cells and HbF levels from baseline to week 24, while Hb levels did not meaningfully change. Three of the eight evaluable subjects (33%) had absolute increases in HbF percentage of greater than 1%, with a mean absolute increase in HbF percentage of 4.3% in that subset of patients. Dose dependent improvements in several markers of hemolysis were observed from baseline through week 24, with the greatest improvement occurring when patients were on the 100 mg dose. hsCRP and NT-proBNP values through week 24 slightly increased from baseline. There was a single placebo patient from Population B1, as other patients did not have evaluable week 24 PD biomarker data due in part to missing study visits. Therefore, this single patient is not included in the table below. A summary of the mean results from the IMR-687+HU treatment arm are as follows:

    MeasureBaseline

    Value
    Week 24

    Value
    Percent Change from

    Baseline to Week 24
    HbF percentage (%)18.619.86.5%
    F-cell percentage (%)58.861.44.4%
    Hb (g/dL)9.59.4-1.1%
    Markers of Hemolysis
    Reticulocytes (%)7.55.3-29.3%
    Absolute reticulocyte count (×109/L)185137-25.9%
    Indirect bilirubin (µmol/L)34.937.98.6%
    LDH (IU/L)351340-3.1%
    Markers of Inflammation & Cardiac Stress
    hsCRP (mg/L)11.512.58.7%
    NTproBNP (ng/L)28431711.6%

    Population A/B (monotherapy, combination therapy)

    Imara previously reported interim results within Populations A and B. Subsequently, four additional patients completed 24 weeks of dosing in the Population A monotherapy arm. A completers analysis in this group showed that the high dose of IMR-687 (100 mg/200 mg) resulted in a relative increase in F-cell percentage of 13.3% from baseline (p=0.025) and a mean absolute increase in HbF percentage from baseline of 0.9%. Three of the eight evaluable subjects (38%) in Population A recorded absolute HbF percentage increases of greater than 1%, with a mean absolute increase in HbF percentage of 3.1% in that subset of patients.  

    In Population B, we examined the PK of IMR-687+HU as compared to HU alone. The PK data in the second interim analysis indicated that treatment with IMR-687+HU did not result in changes in HU PK.

    Imara anticipates that it will present additional study details at a future medical meeting.

    About IMR-687

    IMR-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.

    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. 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 Statements

    Statements 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) plan to release additional data on the Phase 2a clinical trial of IMR-687 in patients with sickle cell disease, (ii) content of, and timing with respect to, the reporting of data from the open label extension clinical trial evaluating IMR-687 in patients with sickle cell disease, (iii) 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 and (iv) 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:

    Gina Nugent

    Ten Bridge Communications

    617-460-3579

    Investor Contact:

    Michael Gray

    617-835-4061



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  5. Preliminary data as of August 2020 from ongoing Phase 2a open label extension trial showed increases in HbF percentage and F-cells after approximately six months of treatment

    Case reports showed additional improvements in clinical outcomes, hemoglobin and related biomarkers of hemolysis

    IMR-687 continued to be well tolerated as a monotherapy and in combination with hydroxyurea

    BOSTON, Dec. 07, 2020 (GLOBE NEWSWIRE) -- 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 that it presented two case reports from the ongoing IMR-687 Phase 2a open label extension (OLE…

    Preliminary data as of August 2020 from ongoing Phase 2a open label extension trial showed increases in HbF percentage and F-cells after approximately six months of treatment

    Case reports showed additional improvements in clinical outcomes, hemoglobin and related biomarkers of hemolysis

    IMR-687 continued to be well tolerated as a monotherapy and in combination with hydroxyurea

    BOSTON, Dec. 07, 2020 (GLOBE NEWSWIRE) -- 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 that it presented two case reports from the ongoing IMR-687 Phase 2a open label extension (OLE) clinical trial in adult patients with sickle cell disease (SCD) at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition. IMR-687 is an oral, once-a-day, potentially disease modifying investigational treatment for sickle cell disease (SCD) and beta-thalassemia.

    Preliminary data in these case reports, as of an August 2020 review, showed that the first two SCD patients treated for approximately six months or greater in the OLE trial demonstrated higher HbF percentage and F-cell increases compared to baseline when treated with IMR-687, as a monotherapy or in combination with stable dose hydroxyurea (HU). Treatment with IMR-687 was also associated with improvements in clinical outcomes and red cell markers, including hemoglobin (Hb) levels and measures of hemolysis in both patients. IMR-687 was well tolerated by both patients.

    "We are encouraged by these case reports presented at ASH demonstrating that treatment with IMR-687, at approximately six months or greater, provided benefit to these two patients with sickle cell disease," said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara. "We believe these reports may help elucidate the potential benefit of longer term use with IMR-687 and are pleased that we have recently enrolled the 24th patient in the OLE trial. We expect to report additional data on approximately 10 to 15 patients from the OLE trial during the first quarter of 2021."

    Dr. Ballal continued, "Imara is also continuing to dose adult patients with sickle cell disease in our Ardent Phase 2b clinical trial, a randomized, double-blind, placebo controlled clinical trial evaluating the potential treatment benefit of IMR-687 for up to one year of therapy and at higher doses than the OLE."

    Both patients in the case reports were initially administered a daily dose of 100 mg of IMR-687 on the OLE trial, and in the second quarter of 2020, a protocol amendment increased their daily dose to 200 mg. The reported VOC comparisons involve retrospective reviews of the patients' medical records and is therefore not a statistical approach. Highlights of the reports include:

    • Patient #1 received 100 mg (3 months) and 200 mg (3 months) of IMR-687 as monotherapy during the Phase 2a trial. As of June 2020, this patient had been on IMR-687 for 18 months, either as part of the Phase 2a trial (six months) or as part of the OLE trial (additional 12 months). This patient experienced a 55% reduction (38 to 17) in reported vaso-occlusive crises (VOCs) when comparing the 18 months prior to treatment with the 18 months on IMR-687 treatment. Importantly, reductions in VOCs correlated with increased time on therapy. Improvements as compared to baseline across key red cell markers, including HbF, F-cells, Hb and other markers of hemolysis were also observed.



    • Patient #2 completed approximately six months of treatment with IMR-687 (100mg for 4 months/200 mg for ~2 months) on the OLE trial as of August 2020. This patient entered the Phase 2a trial as part of the HU combination sub-study and was randomized to the placebo dose group, and therefore never received IMR-687 during the Phase 2a trial. This patient started the OLE trial with IMR-687 approximately 14 months after completing the Phase 2a trial while remaining on a stable background dose of HU during this period and throughout the OLE trial. This patient experienced zero VOCs in the six month period while on IMR-687 in combination with HU, as compared to 15 reported VOCs in the 6 months prior to commencing treatment with IMR-687, while on HU alone. Improvements as compared to baseline across key red cell markers were also observed, including, HbF, F-cells, Hb and other markers of hemolysis.

    The presentation, titled "Benefits and Safety of Long-Term Use of IMR-687 as Monotherapy or in Combination with a Stable Dose of Hydroxyurea (HU) in 2 Adult Sickle Cell Patients," was made by Lanetta Bronte-Hall, M.D., M.P.H., M.S.P.H., President and Chief Executive Officer of the Foundation for Sickle Cell Disease Research and shared virtually on the ASH website on Sunday, December 6, 2020. The presentation can be found at the Investors section of Imara's website.

    About IMR-687

    IMR-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.

    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. 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 Statements

    Statements 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 made by Dr. Ballal in this press release and statements relating to the (i) content of, and timing with respect to, reporting of data from the OLE trial evaluating IMR-687 in patients with sickle cell disease, (ii) clinical trial design with respect to the Ardent Phase 2b clinical trial and (iii) the Company's beliefs regarding the strength of its clinical data, the 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:

    Gina Nugent

    Ten Bridge Communications

    617-460-3579

    Investor Contact:

    Michael Gray

    617-835-4061



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