REG-Arix Bioscience PLC Arix Bioscience PLC: Imara Presents Clinical and Preclinical Tovinontrine (IMR-687) Data at the American Society of Hematology (ASH) Annual Meeting 2021

Arix BioscienceAnnouncement

13/12/2021 15:55

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   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

    1 ir@arixbioscience.com

    

   Powerscourt Group

   Sarah MacLeod, Ibrahim Khalil

   +44 (0)20 7250 1446

    2 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.  3 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  4 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  5 www.imaratx.com.

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   ISIN:           GB00BD045071
   Category Code:  PFU
   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.:   129882
   EQS News ID:    1257301


    
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