Key Points
- 01HMB-002 shows dose-dependent rises in VWF and Factor VIII with ≥2.4-fold peak increases
- 02Clinical data indicate normalized thrombin generation and APTT with HMB-002
- 03Single ascending dose cohorts show sharply lower treated bleeding versus baseline
- 04Hemab unveils HMB-003 antifibrinolytic with ~1 week preclinical activity
Hemab updates HMB-002 program in von Willebrand disease
Hemab Therapeutics has released new clinical data for HMB-002, an investigational therapy in development for von Willebrand disease. The data show that treatment with HMB-002 led to dose-dependent increases in von Willebrand Factor (VWF) and Factor VIII (FVIII), with peak rises of at least 2.4-fold. These biomarker changes were accompanied by normalization of peak thrombin generation and activated partial thromboplastin time (APTT), indicating a shift toward more typical coagulation activity.
The durability of HMB-002’s effect was reported to support potential once-monthly subcutaneous dosing. This dosing profile is being explored within the ongoing clinical program, which is registered under ClinicalTrials.gov identifiers NCT06610201 and NCT06754852. The combination of pharmacodynamic effects and dosing convenience is a central focus of the development strategy.
Bleeding outcomes in single ascending dose cohorts
In the single ascending dose portion of the HMB-002 study, 8 of 9 evaluable patients experienced no treated bleeds during the 28 days following administration. Across these cohorts, the mean annualized treated bleeding rate (ATBR) was reported as 1.6. This compared with a pre-treatment baseline mean ATBR of 20.1, calculated from up to 5.5 months of bleeding data before exposure to HMB-002.
These early results suggest a marked reduction in treated bleeding episodes in the period after a single dose, while also aligning with the observed improvements in coagulation biomarkers. The findings are being used to guide further dose selection and regimen design in subsequent phases of clinical development.
Introduction of HMB-003 antifibrinolytic program
Alongside the HMB-002 update, Hemab introduced HMB-003, a new antifibrinolytic program initially targeting heavy menstrual bleeding and other bleeding settings. HMB-003 is described as a fatty-acid-conjugated, peptide-based plasmin inhibitor administered subcutaneously. It is designed as a non-hormonal option intended to reduce bleeding through inhibition of fibrinolysis.
Preclinical data in minipigs following a single subcutaneous dose of HMB-003 showed that peak plasma concentrations were achieved within hours. The same studies indicated approximately one week of sustained antifibrinolytic activity. This profile supports the concept of cycle-matched dosing for heavy menstrual bleeding, in which treatment could be timed to periods of greatest need.
Pipeline positioning and next steps
With HMB-002 generating proof-of-mechanism data and HMB-003 advancing on the basis of preclinical findings, Hemab is building a pipeline focused on bleeding disorders. HMB-002’s clinical studies are formally tracked under NCT06610201 and NCT06754852, providing a framework for ongoing and future evaluations of safety, dosing, and efficacy.
The company’s development activities are being pursued as a publicly traded entity listed on Nasdaq under the ticker COAG. Together, the latest HMB-002 results and the unveiling of HMB-003 outline Hemab’s current priorities in optimizing coagulation and antifibrinolytic strategies across distinct but related bleeding indications.
Key Takeaways
- 01HMB-002 has moved beyond mechanistic theory, showing concurrent biomarker normalization and reduced treated bleeding in early clinical cohorts.
- 02Durable activity supporting potential once-monthly subcutaneous dosing could be a key differentiator for HMB-002 in von Willebrand disease management.
- 03HMB-003 extends Hemab’s focus from coagulation factor modulation into antifibrinolysis, targeting heavy menstrual bleeding with non-hormonal, subcutaneous dosing.
- 04Preclinical evidence of about a week of antifibrinolytic activity for HMB-003 underpins the strategy of cycle-matched use rather than continuous administration.
- 05The references to specific ClinicalTrials.gov identifiers and Nasdaq listing signal structured advancement of Hemab’s programs within a public-company framework.