# Glanzmann thrombasthenia has no approved preventive treatment. A weekly injection enters its final-stage trial - Published: 2026-11-11 (updated 2026-11-11) - Author: [Healthcare News](https://healthcarenews.io/author/healthcarenews-io.md) - Topics: [News](https://healthcarenews.io/news.md) - About: [Hemab Therapeutics](https://www.hemab.com/) - Based on: [Hemab Therapeutics Reports Third Quarter 2026 Financial Results and Provides Corporate Update](https://www.globenewswire.com/news-release/2026/11/10/3399342/0/en/hemab-therapeutics-reports-third-quarter-2026-financial-results-and-provides-corporate-update.html), GlobeNewswire, 2026-11-10 - Based on: [Glanzmann thrombasthenia](https://medlineplus.gov/genetics/condition/glanzmann-thrombasthenia/), MedlinePlus Genetics, U.S. National Library of Medicine - Based on: [A Phase 1/2 Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-001 in Glanzmann Thrombasthenia](https://clinicaltrials.gov/study/NCT06211634), ClinicalTrials.gov - Based on: [A Clinical Study to Assess Sutacimig in Participants With Congenital Factor VII Deficiency](https://clinicaltrials.gov/study/NCT07347249), ClinicalTrials.gov - Based on: [About Hemab](https://www.hemab.com/about-us), Hemab Therapeutics - Source: https://healthcarenews.io/news/glanzmann-thrombasthenia-treatment-weekly-injection-phase-3/ - Publication: Healthcare News - Publisher: Connectively (Terkel, Inc.) - Editorial policy: https://healthcarenews.io/editorial-policy/ - AI use: Connectively's automated system wrote this article with AI from a press release issued by Hemab Therapeutics on November 10, 2026, linked under Sources. Statements about the company and its products are the company's. The illustration was generated with AI. The article was assembled and published automatically, without an editor's review. Report errors to corrections@connectively.us. Glanzmann thrombasthenia treatment today begins only once a bleed has started, because no preventive therapy is approved for the rare inherited bleeding disorder. Hemab Therapeutics said on November 10, 2026, that it has opened SOLARA, a pivotal Phase 3 trial of sutacimig, a once-weekly injection under the skin designed to prevent bleeds. ## Key points - Hemab says SOLARA is the first pivotal trial of a subcutaneous preventive treatment for Glanzmann thrombasthenia (GT), and that its first participants are due to enter the trial in the fourth quarter of 2026. - The open-label, single-arm trial plans to enroll about 75 people aged 12 to 70 who had at least four treated bleeds in the 12 months before screening, at sites in the United States and other countries. - Each participant first records bleeds for 24 weeks on their usual on-demand care, then takes sutacimig 0.2 mg/kg once a week for 48 weeks; the main measure is the yearly rate of treated bleeds in each period. - In the U.S., the FDA has given sutacimig Fast Track, Orphan Drug and Breakthrough Therapy designations for GT, according to the company. - Hemab reported $430.2 million in cash, cash equivalents and marketable securities at September 30, 2026, which it expects to fund operations into 2029. ## What Glanzmann thrombasthenia treatment exists today? Only treatment given when bleeding happens: Hemab's release lists platelet transfusions, antifibrinolytic drugs, recombinant Factor VIIa and, in some cases, bone marrow transplantation. In GT, mutations in the ITGA2B or ITGB3 gene leave platelets short of a receptor they need to clump together, so clots form poorly; people with type I, the most common form, have less than 5 percent of normal receptor levels, and about a quarter of patients bleed in the gastrointestinal tract, according to [MedlinePlus Genetics](https://medlineplus.gov/genetics/condition/glanzmann-thrombasthenia/) at the U.S. National Library of Medicine. The condition is inherited in an autosomal recessive pattern: a child is affected when both copies of the gene carry a mutation, and parents who each carry one copy usually have no symptoms. Hemab puts its prevalence at about 1 in 100,000 people in high-prevalence regions such as the Gulf Cooperation Council countries, and between 1 in 350,000 and 1 in 600,000 in the United States. The company also cites its Glanzmann's 360 natural history study, in which 88% of 117 participants reported a bleed in the previous week and 65% needed a bleed-related hospital visit in the prior six months, as cited in the release. ## How does the SOLARA trial work? Every participant acts as their own comparison. For the first 24 weeks they stay on their usual on-demand care while bleeds that need treatment are recorded as they happen; for the next 48 weeks they inject sutacimig once a week. The primary endpoint compares the annualized treated bleed rate between the two periods, and secondary endpoints include high-intensity bleeds, days with treated bleeding, safety and immunogenicity. A data safety monitoring committee decides when adolescents can join, and those who finish can continue on sutacimig in a separate extension study. Hemab says the FDA recommended it consider a randomized controlled design and acknowledged the company's concerns about whether randomizing is feasible in GT. The company chose the single-arm design, citing how widely treated bleeding rates vary between patients, the varied patient population and the practical difficulty of randomized trials in a rare disease. SOLARA runs under Hemab's active Investigational New Drug application. ## How is sutacimig meant to work? Sutacimig is a bispecific antibody: Hemab says one arm binds and stabilizes the body's own Factor VIIa while the other binds TLT-1, a protein on activated platelets. The aim is for Factor VIIa to build up in the blood and gather on the surface of activated platelets, where it is designed to amplify thrombin generation. SOLARA follows a Phase 1/2 study of sutacimig, then called HMB-001, in people with GT, which began in December 2022 and is registered on ClinicalTrials.gov as [NCT06211634](https://clinicaltrials.gov/study/NCT06211634). The company is also testing sutacimig in Factor VII deficiency, another inherited bleeding disorder. It reported that in the first two participants with severe disease, a single dose shortened prothrombin time by more than 50%, and it plans to present updated data from that trial ([NCT07347249](https://clinicaltrials.gov/study/NCT07347249)) at the American Society of Hematology (ASH) annual meeting on December 14, 2026. ## What does SOLARA mean for patients and clinicians? Our analysis: for people with GT, SOLARA tests a move from treating each bleed as it comes, with options such as platelet transfusions or recombinant Factor VIIa, to a weekly injection meant to stop bleeds before they start. Because the trial is open-label with a single arm, every participant who completes the 24-week run-in receives sutacimig; there is no placebo group. For hematologists and treatment centers, the patients who fit are those aged 12 to 70 whose bleeding needed treatment four or more times in the past year. Each participant's own run-in record is the baseline the drug is measured against, so careful bleed records during those 24 weeks matter to the result. Healthcare News has also covered other trials in inherited and rare diseases, including [base editing for sickle cell disease](https://healthcarenews.io/news/base-editing-for-sickle-cell-disease/) and [a Stargardt disease trial](https://healthcarenews.io/news/stargardt-disease-clinical-trial-city-rbp4/). ## What else did Hemab report? Alongside its third-quarter results, Hemab said it dosed the first participant in a Phase 1 trial of HMB-003, an injectable drug it is developing for heavy menstrual bleeding, and expects that trial's first clinical data in mid-2027. It reported a third-quarter net loss of $27.3 million and, in September, added Keli Walbert, a former Horizon Therapeutics commercial executive, to its board. ## Frequently asked questions ### Who can enroll in SOLARA? People with Glanzmann thrombasthenia aged 12 to 70 whose bleeding needed treatment at least four times in the year before screening. Adolescents join once the data safety monitoring committee allows it. ### When do the first SOLARA participants start? Hemab says the first participants have given consent and are scheduled to begin the 24-week run-in period in the fourth quarter of 2026. ### Has sutacimig been recognized by regulators outside the U.S.? Yes, according to Hemab: the European Medicines Agency granted it Orphan Medicinal Product designation and access to its PRIME scheme for GT, and the UK's MHRA gave it an Innovative Licensing and Access Pathway designation. ### Which other sutacimig trials are registered? The Phase 1/2 study in GT is [NCT06211634](https://clinicaltrials.gov/study/NCT06211634), and the Phase 2b study in Factor VII deficiency is [NCT07347249](https://clinicaltrials.gov/study/NCT07347249), both on ClinicalTrials.gov with Hemab as sponsor. ### Where is Hemab based and where does it trade? Hemab issued the announcement from Cambridge, Massachusetts, and Copenhagen, Denmark. Its shares trade on Nasdaq under the ticker COAG. ## Sources - [Hemab Therapeutics Reports Third Quarter 2026 Financial Results and Provides Corporate Update](https://www.globenewswire.com/news-release/2026/11/10/3399342/0/en/hemab-therapeutics-reports-third-quarter-2026-financial-results-and-provides-corporate-update.html): press release from Hemab Therapeutics via GlobeNewswire, 10 November 2026. - [Glanzmann thrombasthenia](https://medlineplus.gov/genetics/condition/glanzmann-thrombasthenia/): condition summary from MedlinePlus Genetics, U.S. National Library of Medicine. - [NCT06211634](https://clinicaltrials.gov/study/NCT06211634) and [NCT07347249](https://clinicaltrials.gov/study/NCT07347249): Hemab's sutacimig study records on ClinicalTrials.gov. - [About Hemab](https://www.hemab.com/about-us): the company's leadership and board.