CAMBRIDGE, Mass. and COPENHAGEN, Denmark, July 12, 2026
Hemab Therapeutics announced encouraging new clinical findings from its HMB-002 program for Von Willebrand Disease (VWD) while introducing HMB-003, a novel investigational therapy for heavy menstrual bleeding (HMB), during presentations at the International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress in Paris. The company reported that HMB-002 demonstrated strong proof of mechanism by producing dose-dependent increases of at least 2.4-fold in endogenous Von Willebrand Factor (VWF) and Factor VIII (FVIII), restoring key markers of blood clotting and supporting the potential for monthly subcutaneous dosing.
At the same scientific meeting, Hemab unveiled HMB-003, a non-hormonal, peptide-based direct plasmin inhibitor engineered to provide prolonged antifibrinolytic activity for reducing bleeding across multiple clinical settings, beginning with heavy menstrual bleeding. Together, these developments strengthen Hemab’s growing pipeline focused on addressing significant unmet needs in bleeding disorders through innovative therapeutic approaches.
HMB-002 Demonstrates Strong Biological Activity and Favorable Safety Profile in Von Willebrand Disease
The latest first-in-human clinical data highlighted the potential of HMB-002 to become the first subcutaneous prophylactic therapy designed to address the underlying biology of Von Willebrand Disease rather than replacing deficient clotting factors. Across all evaluated dose cohorts, treatment produced dose-dependent elevations in both VWF and FVIII, with the highest-dose 150 mg cohort achieving peak increases exceeding 2.4-fold, alongside normalization of peak thrombin generation and activated partial thromboplastin time (APTT). Pharmacokinetic analyses also demonstrated an extended half-life, supporting the possibility of convenient once-monthly administration.
Importantly, the investigational antibody maintained a favorable safety profile throughout the study, with most treatment-emergent adverse events classified as mild to moderate, no serious adverse events related to treatment, and no thromboembolic events, thrombocytopenia, injection-site reactions, or hypersensitivity reactions reported. Although the single ascending dose study was not designed to establish clinical efficacy, preliminary observations showed that eight of nine evaluable patients experienced no treated bleeding episodes during the 28 days following HMB-002 administration, suggesting encouraging early clinical activity worthy of further investigation.
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HMB-003 Introduces a Novel Non-Hormonal Strategy for Heavy Menstrual Bleeding
Hemab also announced the launch of HMB-003, expanding its pipeline beyond inherited bleeding disorders into broader indications with substantial unmet medical need. The investigational therapy is a fatty-acid-conjugated peptide designed to directly inhibit plasmin, the enzyme responsible for clot breakdown, thereby stabilizing blood clots without affecting thrombin generation or platelet function. Unlike existing hormonal treatment approaches commonly used for heavy menstrual bleeding, HMB-003 is designed as a non-hormonal therapeutic option capable of delivering potent, selective, and sustained antifibrinolytic activity.
Preclinical studies demonstrated that following a single subcutaneous injection, therapeutic drug levels and antifibrinolytic effects were maintained for approximately one week, supporting a dosing strategy aligned with the menstrual cycle. Company executives emphasized that heavy menstrual bleeding affects approximately one in three women, often leading to anemia, fatigue, reduced quality of life, and significant social and economic burden, while treatment options have remained largely unchanged for decades. Hemab believes HMB-003 has the potential to introduce a differentiated therapeutic alternative that directly addresses excessive bleeding without hormonal intervention.
Hemab Strengthens Pipeline Focused on Next-Generation Bleeding Disorder Therapies
The presentations at ISTH 2026 reinforce Hemab Therapeutics’ strategy of developing innovative therapies that target the biological mechanisms responsible for bleeding disorders rather than relying solely on conventional replacement therapies. HMB-002 is designed to protect endogenous Von Willebrand Factor from degradation by targeting its C-terminal CK domain, enabling sustained increases in naturally occurring clotting proteins while preserving normal physiological function.
Meanwhile, HMB-003 broadens the company’s pipeline by targeting plasmin inhibition, a validated mechanism with potential applications extending beyond heavy menstrual bleeding to hereditary hemorrhagic telangiectasia and peri-operative bleeding management. With positive early clinical findings supporting HMB-002 and the introduction of a differentiated non-hormonal antifibrinolytic platform, Hemab continues to advance a portfolio of next-generation therapies aimed at improving long-term management of coagulation disorders and addressing significant unmet medical needs across hematology.
Source: Hemab Therapeutics,press release
