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Imara Inc. (Nasdaq: IMRA) has announced a change in the primary endpoint for its Ardent Phase 2b clinical trial of tovinontrine (IMR-687) in patients with sickle cell disease, following a recommendation from the FDA. The new primary endpoint will focus on the annualized rate of vaso-occlusive crises (VOCs), while fetal hemoglobin (HbF) response remains a secondary endpoint. No changes to the trial's conduct or size are planned. The first analysis of VOC rates is anticipated in Q1 2022, with final data expected in H2 2022. Tovinontrine has received various designations from the FDA and the European Commission.
Imara Inc. (Nasdaq: IMRA) announced positive interim data from its Forte Phase 2b clinical trial of tovinontrine in transfusion-dependent beta-thalassemia patients. Interim analysis showed a favorable trend in transfusion burden reduction at higher doses, with a notable safety profile. Of 43 subjects, 54% had a severe genotype, and the majority of those receiving higher doses experienced a significant decrease in transfusion needs. The trial continues, with expected efficacy results in Q1 2022. The FDA has granted several designations for tovinontrine, highlighting its therapeutic potential.
Imara Inc. (Nasdaq: IMRA) has announced significant updates regarding its clinical trials and financial results for Q3 2021. The company expects to reveal interim analysis data from the Phase 2b trials of tovinontrine (IMR-687) for sickle cell disease and beta-thalassemia in Q4 2021 and Q1 2022, respectively. Imara introduced IMR-261, a new Nrf2 activator, and is set to commence a Phase 2 trial for heart failure in 2022. Financially, Imara reported a net loss of $13.6 million, with cash reserves of $102.8 million, sufficient to fund operations into Q1 2023.
Imara Inc. (Nasdaq: IMRA) has announced preclinical data demonstrating the efficacy of tovinontrine (IMR-687) in three mouse models of heart failure with preserved ejection fraction (HFpEF). The study showed that tovinontrine effectively prevented cardiac hypertrophy and renal dysfunction, marking it as a promising option for HFpEF treatment. Imara also appointed Toni Bransford, M.D., as Vice President of Clinical Development to lead a Phase 2 trial for HFpEF, expected to start in 2022. The data will be presented at the American Heart Association Scientific Sessions on November 13, 2021.
Imara Inc. (Nasdaq: IMRA) will host a conference call and webcast on November 9, 2021, at 8:30 a.m. ET to discuss its financial results for Q3 2021, ending September 30, 2021.
The event will cover recent business highlights and can be accessed by calling 1 (833) 519-1307 (U.S.) or +1 (914) 800-3873 (international) with conference ID 1235955. The live webcast will be available on the company's website, with a replay archived afterward.
Imara focuses on developing therapeutics for rare genetic disorders related to hemoglobin, including sickle cell disease and beta-thalassemia.
Imara Inc. (Nasdaq: IMRA) announced that it will present data from the Phase 2a open-label extension study of tovinontrine (IMR-687) for sickle cell disease at the ASH Annual Meeting on December 11-14, 2021. The presentation will include 12-month vaso-occlusive crisis (VOC) data. Additionally, the company will introduce IMR-261, a novel oral Nrf2 activator shown to reactivate fetal hemoglobin and reduce VOCs in sickle cell models. Both assets are crucial in their efforts to develop therapeutics for hemoglobin-related disorders.
Imara Inc. (Nasdaq: IMRA) is set to participate in two virtual investor conferences in September 2021. The company will take part in the SVB Leerink CybeRx Series on September 22 and 23, focusing on neuromuscular and rare diseases. Additionally, Rahul Ballal, Ph.D., President and CEO, will present at the 2021 Cantor Virtual Global Healthcare Conference on September 29 at 2:00 p.m. ET. A live webcast of the presentation will be available on the company’s website.
Imara is advancing IMR-687, a potential treatment for sickle cell disease and beta-thalassemia.
Imara Inc. (Nasdaq: IMRA) announced participation in three key virtual investor conferences in September 2021. The events include the Citi 16th Annual BioPharma Virtual Conference on September 10, where Dr. Rahul Ballal will discuss benign hematology, and the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, featuring a pre-recorded presentation from Dr. Ballal. Additionally, on September 15, both Dr. Ballal and Dr. Ken Attie will engage in a fireside chat at the Morgan Stanley 19th Annual Global Healthcare Conference.
Imara Inc. (Nasdaq: IMRA) reported positive progress in its clinical trials for IMR-687 (tovinontrine) in sickle cell disease and beta-thalassemia, with accelerated patient enrollment and expected interim data in Q4 2021. The company completed a $50 million public offering, extending its cash runway into 2022. Q2 2021 net loss increased to $13.2 million, or $0.74 per share, from $10.2 million, or $0.59 per share, in Q2 2020. R&D expenses rose due to clinical developments. Financial guidance estimates R&D expenses between $42.5 million and $47.5 million for 2021.
Imara Inc. announced the completion of patient enrollment in its Ardent Phase 2b clinical trial of IMR-687 for sickle cell disease. The trial aims to evaluate the safety and efficacy of this potent PDE9 inhibitor. Interim analysis results are expected in Q4 2021, with primary endpoint readout anticipated in Q1 2022. The USAN Council has adopted tovinontrine as the generic name for IMR-687, highlighting its potential global impact.
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