Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SerpinPC · 1 trial · 2 indications
Number of Participants with One or More Drug Related Adverse Events (AEs) or any Serious AEs
| Arm | Type | Description |
|---|---|---|
| Part 1a - Cohort 1 | EXPERIMENTAL | A single IV infusion of 0.0003 mg/kg SerpinPC in healthy subjects. |
| Part 1a - Cohort 2 | EXPERIMENTAL | A single IV infusion of 0.001 mg/kg SerpinPC in healthy subjects. |
| Part 1a - Cohort 3 | EXPERIMENTAL | A single IV infusion of 0.003 mg/kg SerpinPC in healthy subjects. |
| Part 1a - Cohort 4 | EXPERIMENTAL | A single IV infusion of 0.01 mg/kg SerpinPC in healthy subjects. |
| Part 1a - Cohort 5 | EXPERIMENTAL | A single SC dose of 0.03 mg/kg SerpinPC and a single SC dose of placebo in healthy subjects. |
| Part 1b - Cohort 6 | EXPERIMENTAL | A single SC dose of 0.1 mg/kg SerpinPC and a single SC dose of placebo in patients. |
| Part 1b - Cohort 7 | EXPERIMENTAL | A single SC dose of 0.3 mg/kg SerpinPC and a single SC dose of placebo in patients. |
| Part 1b - Cohort 8 | EXPERIMENTAL | A single SC dose of 0.6 mg/kg SerpinPC and a single SC dose of placebo in patients. |
| Part 1b - Cohort 9 | EXPERIMENTAL | Two single SC doses of 0.6 mg/kg SerpinPC in patients. |
| Part 2 | EXPERIMENTAL | Up to 3 SC doses may be selected for Part 2 and each patient will be assigned a single SerpinPC dose level (and placebo). The dose for Part 2 will be determined from ongoing review of the Part 1 data. The dose in Part will not exceed 1.2 mg/kg, or the highest dose deemed safe from Part 1b. |
| Part 3 | EXPERIMENTAL | A single flat SC dose of SerpinPC will be administered every 4 weeks for 48 weeks for patients who have completed Week 24 of Part 2. The dose level will be chosen after reviewing Part 2 data and will not exceed maximum dose level in Part 2. |
| Part 4 | EXPERIMENTAL | SC doses of 1.2 mg/kg SerpinPC will be administered every 2 weeks for 24 weeks for patients who have completed Week 48 of Part 3. |
| Part 5 | EXPERIMENTAL | SC doses of 1.2 mg/kg SerpinPC will be administered every 2 weeks for 52 weeks for patients who have completed Week 24 of Part 4. |
| Part 6 | EXPERIMENTAL | A single flat SC dose of 60mg SerpinPC will be administered every 2 weeks for 52 weeks for patients who have completed Week 52 of Part 5. |
| Name | Type | Description |
|---|---|---|
| SerpinPC | DRUG | Administered as IV infusion (over 30 minutes) or SC injection (abdomen) according to cohort dosing instructions. |
| Placebo | DRUG | Matching placebo administered by SC injection according to cohort dosing instructions. |
Inclusion Criteria: Part 1a (Healthy Subjects) 1. Males age ≥18 years and ≤55 years. 2. Capable of giving written informed consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or delegate. 3. Willingness ...
Top 8 of 9 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 15 | PHASE3 | Concizumab, Mim8, Denecimig, NNC0442-0344 A, turoctocog alfa pegol |
| Sanofi SA Sponsored ADR | SNY | 5 | PHASE3 | Fitusiran, efanesoctocog alfa |
| Pfizer Inc. | PFE | 8 | PHASE3 | Fidanacogene elaparvovec, Marstacimab |
| BioMarin Pharmaceutical Inc. | BMRN | 2 | PHASE3 | Valoctocogene roxaparvovec |
| Hoffmann-La Roche | RHHBY | 8 | PHASE3 | Emicizumab, NXT007, SPK-8011QQ, SPK-8011, SPK-8016 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE1 | REGV131, LNP1265 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE1 | AskBio009 |
| Bayer | BAYRY | 6 | - | Damoctocog-alfa-pegol |
SerpinPC is an investigational therapy being developed for hemophilia A, a bleeding disorder. It has been studied in a Phase 1 trial that enrolled healthy men and men with severe blood disorders, including hemophilia A and B. SerpinPC has not been approved by the FDA and remains in clinical development.
SerpinPC is being developed by Centessa Pharmaceuticals plc, which trades under the ticker CNTA. The company is the sponsor of the clinical program evaluating SerpinPC in bleeding disorders.
SerpinPC is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The FDA has granted SerpinPC a Fast Track designation, which is intended to expedite review of drugs that address serious conditions and unmet medical needs.
SerpinPC has been evaluated in a single completed Phase 1 trial, NCT04073498, titled The Safety and Tolerability of SerpinPC in Healthy Men and in Men with Severe Blood Disorders (haemophilia a and B). The trial enrolled 39 male participants aged 18 years and older across Georgia, Moldova, and the United Kingdom.
SerpinPC is not FDA approved. It is an investigational drug still in clinical development, with only a completed Phase 1 trial. The FDA has granted it Fast Track designation, a status that supports accelerated development and review but does not constitute approval.