- |||||||||| tovinontrine (IMR-687) / Imara, Inc
Trial completion date, Trial termination, Trial primary completion date: A Study of IMR-687 in Subjects With Beta Thalassemia (clinicaltrials.gov) - May 13, 2022 P2, N=122, Terminated, Trial completion date: Jan 2023 --> May 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2023 --> Mar 2022; IMR-BTL-201demonstrated that while IMR-687 was generally well-tolerated, it failed to show any meaningful benefit in transfusion burden or improvement in most disease-related biomarkers. So, the sponsor has decided to discontinue this study
- |||||||||| tovinontrine (IMR-687) / Imara, Inc
Trial completion date, Trial termination, Trial primary completion date: A Study of IMR-687 in Subjects With Sickle Cell Disease (clinicaltrials.gov) - May 13, 2022 P2b, N=115, Terminated, Active, not recruiting --> Terminated | Trial primary completion date: Sep 2022 --> Mar 2022 | Trial completion date: Sep 2022 --> May 2022; A recently conducted Interim analysis of IMR-SCD-301 demonstrated that while IMR-687 was generally well-tolerated, it failed to meet its primary efficacy endpoint. So, the sponsor has decided to discontinue this study.
- |||||||||| tovinontrine (IMR-687) / Imara, Inc
Trial primary completion date: A Study of IMR-687 in Subjects With Sickle Cell Disease (clinicaltrials.gov) - Apr 6, 2022 P2b, N=99, Active, not recruiting, So, the sponsor has decided to discontinue this study. Trial primary completion date: Mar 2022 --> Sep 2022
- |||||||||| tovinontrine (IMR-687) / Imara, Inc
Enrollment closed, Trial completion date, Trial primary completion date: A Study of IMR-687 in Subjects With Beta Thalassemia (clinicaltrials.gov) - Mar 2, 2022 P2, N=120, Active, not recruiting, Enrolling by invitation --> Active, not recruiting Recruiting --> Active, not recruiting | Trial completion date: May 2022 --> Jan 2023 | Trial primary completion date: May 2022 --> Jan 2023
- |||||||||| sirolimus / Generic mfg.
Journal: β-Thalassemia: evolving treatment options beyond transfusion and iron chelation. (Pubmed Central) - Feb 16, 2022 In addition, 2 gene editing techniques (CRISPR-Cas9 and zinc-finger nucleases) are under investigation as a means to silence BCL11A to induce HbF with agents designated CTX001 and ST-400, respectively. Results from the many clinical trials for these agents will yield results in the next few years, which may end the era of relying on transfusion alone as the mainstay of thalassemia therapy.
- |||||||||| tovinontrine (IMR-687) / Imara, Inc
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 (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3648; P2, P2a, P IMR-687 treatment reduced the annualized rate of VOCs and increased HbF (%) and F-cells (%). Based on these encouraging data, a Phase 2b study (NCT04474314) is ongoing to further explore IMR-687 at doses up to 400 mg daily as a disease-modifying therapy for SCD.
- |||||||||| tovinontrine (IMR-687) / Imara, Inc
PDE9 Inhibition By IMR-687 Improves Markers of Beta-Thalassemia in the Hbbth1/th1 Experimental Mouse Model (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_2485; P2 These results support a role for IMR-687 in beta-thalassemia by enabling RBC maturation and improving ineffective erythropoiesis, key components in ameliorating disease pathology. Clinical testing of IMR-687 (up to 400 mg) as a once daily, oral tablet is currently ongoing in a Phase 2 study of patients with beta-thalassemia (NCT04411082).
- |||||||||| tovinontrine (IMR-687) / Imara, Inc
Enrollment closed, Trial primary completion date: A Study of IMR-687 in Subjects With Sickle Cell Disease (clinicaltrials.gov) - Aug 26, 2021 P2b, N=99, Active, not recruiting, IMR-687 may be a promising candidate therapy for testing in clinical trials of human HFpEF. Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2021 --> Mar 2022
- |||||||||| IMR-687 / Imara, Inc, VIT-2763 / Vifor, Reblozyl (luspatercept-aamt) / Acceleron, BMS
Review, Journal: Novel Therapeutic Advances in β-Thalassemia. (Pubmed Central) - Jul 4, 2021 Another therapeutic approach is to target the dysregulation of iron homeostasis, using, for example, hepcidin agonists (inhibitors of TMPRSS6 and minihepcidins) or ferroportin inhibitors (VIT-2763). This review provides an update on the novel therapeutic options that are presently in development at the clinical level in β-thalassemia.
- |||||||||| IMR-687 / Imara, Inc, Zarzio (filgrastim biosimilar) / Novartis
[VIRTUAL] THE SAFETY, PHARMACOKINETICS & PHARMACODYNAMIC EFFECTS OF IMR-687, A HIGHLY-SELECTIVE PDE9 INHIBITOR, IN ADULTS WITH SICKLE CELL DISEASE: PHASE-2A PLACEBO-CONTROLLED & OPEN-LABEL EXTENSION STUDIES () - May 13, 2021 - Abstract #EHA2021EHA_681; Aims The objective of this Phase 2a study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of IMR-687 as a monotherapy and in combination with hydroxyurea (HU) when administered to subjects with SCD...Treatment with 200 mg IMR-687 was shown to increase F-cells (%) with trends for improved HbF, markers of hemolysis and rate of VOCs. Based on these encouraging data, a Phase 2b study testing IMR-687 at higher doses was initiated to further explore IMR-687 as a disease-modifying therapy for SCD.
- |||||||||| tovinontrine (IMR-687) / Imara, Inc
Enrollment change, Trial completion date, Trial primary completion date: An Extension Study of IMR-687 in Adult Patients With Sickle Cell Anemia (clinicaltrials.gov) - Sep 30, 2020 P2, N=30, Enrolling by invitation, These preliminary results potentially show that extended duration of treatment with IMR-687 could be beneficial to SCD patients as a monotherapy or in combination with HU. N=70 --> 30 | Trial completion date: Jun 2024 --> Mar 2025 | Trial primary completion date: Jun 2024 --> Mar 2025
- |||||||||| tovinontrine (IMR-687) / Imara, Inc
Enrollment open: A Study of IMR-687 in Subjects With Beta Thalassemia (clinicaltrials.gov) - Jul 20, 2020 P2, N=120, Recruiting, N=70 --> 30 | Trial completion date: Jun 2024 --> Mar 2025 | Trial primary completion date: Jun 2024 --> Mar 2025 Not yet recruiting --> Recruiting
- |||||||||| tovinontrine (IMR-687) / Imara, Inc
Trial completion date, Trial primary completion date: A Study of IMR-687 in Adult Participants With Sickle Cell Anemia (Homozygous HbSS or Sickle-?0 Thalassemia) (clinicaltrials.gov) - Aug 11, 2019 P2a, N=70, Recruiting, The clinical data generated in this pre-specified interim analysis support further clinical development and testing of higher doses of IMR-687 as a potential disease modifying therapy for SCD. Trial completion date: Jun 2019 --> Sep 2020 | Trial primary completion date: Jun 2019 --> Jul 2020
- |||||||||| tovinontrine (IMR-687) / Imara, Inc
Trial completion, Enrollment change: A Study of IMR-687 in Healthy Adult Volunteers (clinicaltrials.gov) - Jun 3, 2018 P1a, N=66, Completed, Trial completion date: Jun 2019 --> Sep 2020 | Trial primary completion date: Jun 2019 --> Jul 2020 Recruiting --> Completed | N=36 --> 66
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