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Also known as HMB-001
Sutacimig · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Participants with a FVII(a) level of < 10% | EXPERIMENTAL | - |
| Participants with a FVII(a) level of ≥10% | EXPERIMENTAL | - |
| Single or Multiple ascending dose of HMB-001 | EXPERIMENTAL | Open-label, single or multiple ascending dose of HMB-001 |
| Name | Type | Description |
|---|---|---|
| Sutacimig | DRUG | Sutacimig is a subcutaneously administered, bispecific antibody being developed as a prophylactic treatment option for congenital bleeding disorders. |
| HMB-001 | DRUG | HMB-001 is a bispecific antibody being developed as a prophylactic treatment option to prevent and reduce bleeding events in patients with Glanzmann thrombasthenia. |
Inclusion Criteria: 1. Age 18 to 60 years, inclusive, at the time of signing informed consent. 2. Diagnosis of FVIID defined by Factor VII:C activity \< 10% documented on ≥ 2 different laboratory measurements by local laboratory assessment. 3. Severe bleeding history characterized by history of a m...
Sutacimig is being developed to treat two rare bleeding disorders: congenital Factor VII deficiency and Glanzmann thrombasthenia. It is an investigational therapy and has not been approved for commercial use. Both conditions involve impaired blood clotting, and Sutacimig is being studied to address the underlying coagulation defect in each.
Sutacimig targets Factor VIIa and TLT-1. Factor VIIa is a key enzyme in the coagulation cascade that initiates blood clotting, while TLT-1 is a platelet receptor involved in platelet aggregation and clot formation. By engaging both targets, Sutacimig is designed to support hemostasis in patients with rare bleeding disorders.
Sutacimig is being developed by Hemab Therapeutics Holdings, Inc., which trades under the ticker COAG. The company is focused on rare bleeding disorders and is advancing Sutacimig as its lead investigational candidate for congenital Factor VII deficiency and Glanzmann thrombasthenia.
Sutacimig is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The Phase 2 program includes a recruiting study in congenital Factor VII deficiency, and a Phase 1/2 study in Glanzmann thrombasthenia that is active but no longer recruiting new participants.
Sutacimig is being evaluated in two registered clinical trials. NCT07347249 is a Phase 2 study in adults with congenital Factor VII deficiency, recruiting in the United Kingdom. NCT06211634 is a Phase 1/2 study in adults with Glanzmann thrombasthenia, active but not recruiting, conducted across the United States, Belgium, France, Italy, the Netherlands, and the United Kingdom.
Yes, Sutacimig is also known as HMB-001. Both names refer to the same investigational compound developed by Hemab Therapeutics. The earlier Phase 1/2 study in Glanzmann thrombasthenia was registered under the HMB-001 name, while newer registrations use Sutacimig.