Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as HMB-002 (Part A)
HMB-002 · 1 trial · 4 indications
| Arm | Type | Description |
|---|---|---|
| Part A Single Ascending Dose Design | EXPERIMENTAL | A multicenter study to evaluate the safety, tolerability, PK, and PD effect of single dose HMB-002 in participants with Type 1 VWD. |
| Part B Multiple Dose Assessment | EXPERIMENTAL | A multicenter study to evaluate the safety, tolerability, PK, and PD effect of repeat doses of HMB-002, as well as the preliminary prophylactic effects on bleeding events. |
| Part C HMB-002 with Concomitant Factor Concentrate | EXPERIMENTAL | A multicenter study to evaluate the safety and tolerability of a single dose of HMB-002, administered to patients concurrently receiving regular factor concentrate as standard of care. |
| Name | Type | Description |
|---|---|---|
| HMB-002 (Part A) | DRUG | HMB-002 will be administered subcutaneously. Part A will utilize sentinel dosing. The planned duration of study participants in Part A is approximately 12 weeks. |
| HMB-002 (Part B) | DRUG | HMB-002 will be administered subcutaneously. Part B dosing intervals will be determined following evaluation of Part A results. The planned duration of study participants in Part B will be approximately 21 weeks. |
| HMB-002 with Concomitant Factor Concentrate (Part C) (Not Applicable in US) | DRUG | HMB-002 will be administered as a single dose with a concomitant single dose of factor concentrate. The planned duration of study participants in Part C will be approximately 17 weeks. |
Key Inclusion Criteria: 1. Weight 50 to 120 kg, inclusive. 2. Documented diagnosis of Congenital VWD, confirmed by laboratory testing consistent with ISTH/ASH) diagnostic guidelines). 3. Vital signs are within normal ranges at Screening. 4. Participants must meet the following baseline organ functi...
Top 4 of 5 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 4 | PHASE3 | Vonvendi, ADVATE |
| Incyte Corporation | INCY | 2 | PHASE3 | VGA039 |
| Alnylam Pharmaceuticals, Inc | ALNY | 1 | PHASE2 | ALN-6400 |
| Hemab Therapeutics Holdings, Inc. | COAG | 2 | PHASE1 | HMB-002 |
HMB-002 is an investigational small molecule being developed for the treatment of Von Willebrand Disease (VWD), including Type 1, Type 2, and Type 3. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
HMB-002 targets von Willebrand factor (VWF), the protein that is deficient or dysfunctional in Von Willebrand Disease. By targeting VWF, HMB-002 aims to address the underlying cause of the bleeding disorder.
HMB-002 is being developed by Hemab Therapeutics Holdings, Inc., a biopharmaceutical company. The company is publicly traded under the ticker symbol COAG.
HMB-002 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in clinical trials.
HMB-002 is being studied in a Phase 1 clinical trial with the identifier NCT06754852. The trial is titled 'A Study Assessing HMB-002 in Participants With Von Willebrand Disease' and is currently recruiting participants in the United States, Australia, and the United Kingdom.
Yes, HMB-002 is also known as HMB-002 (Part A). This alternative name may be used in the context of the clinical trial to distinguish a specific part or cohort of the study.