REG-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

Arix BioscienceAnnouncement

17/11/2021 17:05

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   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

    1 ir@arixbioscience.com  

    

   Optimum Strategic Communications

   Mary Clark, Manel Mateus

   +44 (0)20 3922 1906

    2 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.  3 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 for reduced 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 β0/β0 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


    
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References

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