Associated tags: Thalassemia, Pharmaceutical industry, Patient, PDE9, Sickle cell disease, Therapy, Heart failure, Heart failure with preserved ejection fraction, COVID-19, Security (finance), SCD, HBF, Fetal hemoglobin, NFE2L2, Development, Inflammation, Hemoglobinopathy, VOC, Society
Locations: NEW YORK, BOSTON, UNITED STATES, MA, US, REDWOOD CITY, CA, NY, NEW YORK CITY, NORTH AMERICA, LOUISIANA
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Monday, November 22, 2021
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Pharmaceutical industry BOSTON, Nov. 22, 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 and other serious diseases, today announced a change to the primary endpoint for the Ardent clinical trial, a Phase 2b study of tovinontrine (IMR-687) in patients with sickle cell disease (SCD), based on the recommendation of the U.S. Food and Drug Administration (FDA).
Key Points:
- In reviewing the Ardent draft SAP and prior to any database lock for analysis, the FDA recommended that Imara change the primary endpoint to be annualized rate of VOCs.
- The endpoint revisions do not affect the conduct of the trial or operational aspects of the study.
- The Ardent Phase 2b clinical trial is a fully-enrolled, global, randomized, double-blind, placebo-controlled, multicenter study with approximately 115 adult patients with sickle cell disease (SCD) enrolled.
- Sickle cell disease (SCD), a hemoglobinopathy, is a rare inherited red blood cell disorder.
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Tuesday, November 16, 2021
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Pharmaceutical industry 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.
Key Points:
- Safety data through week 24 from higher and lower dose groups were pooled for this interim analysis to prevent unblinding of the study.
- 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.
- 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.
- For TDT subjects, the clinical trial is evaluating the effect of tovinontrine versus placebo in reducing transfusion burden.
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Tuesday, November 9, 2021
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Video game BOSTON, Nov. 09, 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 and other serious diseases, today reported financial results for the third quarter ending September 30, 2021 and reviewed recent business highlights.
Key Points:
- Imara expects to report interim data from the Ardent trial in the fourth quarter of 2021, primary efficacy analysis data in the first quarter of 2022 and final analysis data in the second half of 2022.
- Imara expects to report interim data from the TDT cohort in the fourth quarter of 2021 and to conduct a key efficacy analysis of the full TDT cohort in the first quarter of 2022.
- General and Administrative Expenses: General and administrative expenses were $3.3 million for the third quarter of 2021, as compared to $3.0 million for the third quarter of 2020.
- ET to discuss its third quarter 2021 financial results and other business updates.
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Pharmaceutical industry BOSTON, Nov. 08, 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 and other serious diseases, announced data today in three preclinical mouse models of heart failure with preserved ejection fraction (HFpEF) treated with tovinontrine (IMR-687). Selective inhibition of phosphodiesterase-9 (PDE9) with tovinontrine was shown to be effective for prevention and treatment of cardiac hypertrophy and renal dysfunction, indicating that tovinontrine may be a promising treatment option for patients suffering from HFpEF. Imara also announced the appointment of Toni Bransford, M.D., as Vice President of Clinical Development, with responsibilities that include leading the design and execution of a Phase 2 proof-of-concept study in HFpEF. Dr. Bransford holds extensive experience leading clinical development of cardiovascular therapies and specifically HFpEF studies.
Key Points:
- To lead clinical development of tovinontrine as a treatment for HFpEF, Imara has appointed Toni Bransford, M.D., as Vice President of Clinical Development.
- Having dedicated my career to treating heart disease, it is wonderful to see such a renaissance in the field of heart failure and particularly HFpEF.
- Heart failure with preserved Ejection Fraction (HFpEF), also known as diastolic heart failure, is typically due to abnormalities of cardiac filling, which leads to symptoms such as shortness of breath, exercise intolerance, and fluid retention.
- HFpEF is one of the most common forms of heart failure but has relatively few treatment options to improve symptoms and outcomes.
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Thursday, November 4, 2021
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Pharmaceutical industry ET to discuss its financial results for the quarter ended September 30, 2021 and review recent business highlights.
Key Points:
- ET to discuss its financial results for the quarter ended September 30, 2021 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 +1 (914) 800-3873 (international) and referring to conference ID 1235955.
- A replay of the webcast will be archived on the Imara website following the presentation.
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Thursday, November 4, 2021
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Powder metallurgy BOSTON, Nov. 04, 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 and other serious diseases, today announced that it will present clinical and preclinical data at the American Society of Hematology (ASH) Annual Meeting to be held December 11-14, 2021.
Key Points:
- In pre-clinical models of SCD, IMR-261 was observed to reactivate fetal hemoglobin and reduce vaso-occlusive crises.
- Furthermore, in a preclinical model of beta-thalassemia, IMR-261 was observed to increase hemoglobin and enhance red blood cell maturation.
- We have initiated work towards drug product manufacturing for IMR-261, as we explore potential clinical development paths.
- Imara has initiated work on drug product manufacturing for IMR-261, as it explores potential clinical development paths.
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Wednesday, September 15, 2021
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Pharmaceutical industry Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara, will give a presentation at the 2021 Cantor Virtual Global Healthcare Conference on Wednesday, September 29, 2021 at 2:00 p.m.
Key Points:
- Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara, will give a presentation at the 2021 Cantor Virtual Global Healthcare Conference on Wednesday, September 29, 2021 at 2:00 p.m.
- A live webcast of the presentation will be available under "Events and Presentations" in the Investors section of the company's website at www.imaratx.com .
- 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 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.
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Friday, September 3, 2021
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Medical device Dr. Ballal will give a pre-recorded presentation at the H.C. Wainwright 23rd Annual Global Investment Conference which will be made available on September 13, 2021 at 7:00 a.m.
Key Points:
- Dr. Ballal will give a pre-recorded presentation at the H.C. Wainwright 23rd Annual Global Investment Conference which will be made available on September 13, 2021 at 7:00 a.m.
- Dr. Ballal and Dr. Attie will participate in a fireside chat at the Morgan Stanley 19th Annual Global Healthcare Conference on September 15, 2021 at 11:00 a.m.
- 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 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.
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Cryptocurrency Imara expects to report interim data from the Ardent trial in the fourth quarter of 2021, data from the primary efficacy analysis in the first quarter of 2022 and data from the final analysis in the second half of 2022.
Key Points:
- Imara expects to report interim data from the Ardent trial in the fourth quarter of 2021, data from the primary efficacy analysis in the first quarter of 2022 and data from the final analysis in the second half of 2022.
- Research and Development Expenses: Research and development expenses were $10.1 million for the second quarter of 2021, as compared to $7.9 million for the second quarter of 2020.
- General and Administrative Expenses: General and administrative expenses were $3.1 million for the second quarter of 2021, as compared to $2.4 million for the second quarter of 2020.
- ET to discuss its second quarter 2021 financial results and other business updates.
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Pharmaceutical industry We are pleased to achieve this important milestone for IMR-687, said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara.
Key Points:
- We are pleased to achieve this important milestone for IMR-687, said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara.
- Furthermore, we are excited to have enrolled subjects from across the world, including in Africa, making this a truly global effort.
- The Ardent Phase 2b clinical trial is a randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the safety and efficacy of IMR-687 administered once daily in approximately 99 adult patients with sickle cell disease.
- These statements include, but are not limited to, statements relating to the timing with respect to reporting of data from the Ardent Phase 2b clinical trial in patients with sickle cell disease.
