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Imara to Report Data Demonstrating the Potential of Tovinontrine (IMR-687) for the Treatment of Heart Failure with Preserved Ejection Fraction (HFpEF)

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Preclinical data from three different mouse models of HFpEF to be presented at American Heart Association (AHA) Scientific Sessions

HFpEF development to be led by cardiologist Toni Bransford, M.D., FACC, FASE Imara’s new Vice President of Clinical Development

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.

“The data from our pre-clinical models in concert with published literature regarding the role of PDE9 in heart failure suggest that tovinontrine has potential as a treatment for HFpEF,” said Deepak Gupta, M.D., M.S.C.I, Assistant Professor of Medicine at Vanderbilt University Medical Center’s Division of Cardiovascular Medicine. “In three distinct mouse models of HFpEF, compared with control mice, tovinontrine was shown to not only reduce the median size of cardiomyocytes, but also lower plasma B-type and atrial natriuretic peptide levels. Moreover, markers of renal dysfunction, including blood urea nitrogen and urine albumin-to-creatinine ratio, were lower in mice treated with tovinontrine compared with vehicle treated mice in all models. Notably, tovinontrine did not significantly change heart rate or blood pressure. Overall, the results and safety profile in preclinical models of HFpEF are encouraging for the advancement of this program into the clinic.”

“We are excited about extending our footprint into HFpEF with what we believe is a best-in-class PDE9 inhibitor and expect to initiate a Phase 2 clinical trial of tovinontrine in HFpEF in 2022,” said Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara. “While studies of tovinontrine as a treatment for sickle cell disease and beta-thalassemia remain foundational to the company, we are excited by the pre-clinical data announced today, and the recent addition of Dr. Bransford, a deeply experienced clinical developer in the heart failure field.”

A virtual presentation of the preclinical data for tovinontrine in mouse models with HFpEF will take place at the American Heart Association (AHA) Scientific Sessions on Saturday, November 13, 2021 at 8:00 AM ET. A copy of the presentation will be available on the Investors section of the Imara website.

To lead clinical development of tovinontrine as a treatment for HFpEF, Imara has appointed Toni Bransford, M.D., as Vice President of Clinical Development. A cardiologist, Dr. Bransford comes to Imara with 15 years of clinical development experience within global pharmaceuticals, biotech and clinical research organizations. Most recently, Dr. Bransford was a Senior Medical Director at Kaleido Biosciences, where she led clinical research programs for multiple projects and oversaw the translation of discovery programs.

“I’m thrilled to be joining Imara at such an important moment for the company,” said Dr. Bransford. “The potential behind tovinontrine as an accessible treatment for sickle cell disease and beta-thalassemia is very exciting, and I’m honored to have the opportunity to head development on a third possible indication for Imara’s lead candidate. 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. Tovinontrine heralds an expansion of possible medications for a disease with few treatment options today.”

Prior to her roles at Imara and Kaleido, Dr. Bransford accumulated extensive experience in the cardiovascular therapeutic area, previously as Senior Medical Director within the global clinical development program at Novartis, where she was clinical lead for the HFpEF program conducting the PARAMOUNT and PARAGON trials and was also responsible for leading regulatory authority interactions. Dr. Bransford also served at Schering Plough in the cardiovascular therapeutic area in coronary heart disease, as a Medical Director on the thrombin receptor antagonist program and as clinical lead for the TRACER trial. She has also held increasing levels of responsibility working with clinical research organizations, at one point serving as Executive Director of the cardiovascular therapeutic area for the Scientific Solutions Program of Worldwide Clinical Trials. Dr. Bransford earned her B.S. in biology from the University of Texas at Austin and her M.D. from the University of Texas Health San Antonio.

About Heart Failure with Preserved Ejection Fraction
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.

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 including heart failure with preserved ejection fraction (HFpEF). 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 SCD and beta-thalassemia and preclinical development for 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.

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 (i) plans to present preclinical data on tovinontrine (IMR-687) and the quality of such data and (ii) clinical developments plans and timeline for tovinontrine in HFpEF and (iii) beliefs regarding the therapeutic potential of tovinontrine. 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, 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 Bergman
Ten Bridge Communications

Investor Contact:
Michael Gray