Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Coversin · 2 trials · 2 indications
Measurement of serum lactate dehydrogenase (LDH)
LDH is an indicator of disease progression in patients with PNH and is expected to fall to within 2x upper limit of normal (ULN) within 28 days in successfully treated patients. Units are measured in ratio of LDH:ULN, where the ULN is 250 U/L. The primary efficacy endpoint was the LDH AUC from Day 0 to 28 compared with 28 days pretreatment. Data for the 28 days pre-treatment was not collected, and as only one patient was recruited, the LDH values compared with baseline and the ratio of LDH to the Upper Limit of Normal (ULN) are presented.
The number and type of reported AEs will be recorded as well as the opinion of the Principle Investigator (PI) as to their possible relationship to the study drug.
| Arm | Type | Description |
|---|---|---|
| Coversin treatment | EXPERIMENTAL | Coversin - 22.5mg followed by 45mg for 6 months. |
| Coversin (Nomacopan) | OTHER | This is an open label, non-comparator study. Patient will be given a single ablating dose of 0.57mg/kg per subject followed by daily repeat maintenance doses. The initial repeat dose will be 25% of the ablating dose. If this is insufficient to maintain complement inhibition at ≤10% of baseline (pre-treatment) level after 5 days of treatment the daily dose will be increased by doubling until that level of inhibition is achieved. In the event of 100% inhibition being achieved the dose may be titrated downwards at the PI's discretion until a satisfactory clinical result is obtained. If at any point in treatment complement inhibition falls to less than 50% of baseline a further ablating dose of 0.57mg/kg should be given. Coversin lyophilised powder in each vial was diluted with 0.6 mL water for injection prior to use. |
| Name | Type | Description |
|---|---|---|
| Coversin | DRUG | Coversin - 22.5mg followed by 45mg for 6 months. |
Inclusion Criteria: 1. Patients with known PNH. 2. Aged 18 and above. No upper age limit. 3. Lactate dehydrogenase (LDH) ≥1.5 upper limit of normal. 4. Must agree to use two methods of contraception that are ≥99% effective in preventing pregnancy. 5. Resistance to eculizumab (Soliris®). 6. Voluntar...
Coversin is an investigational small molecule being developed for Paroxysmal Nocturnal Haemoglobinuria (PNH), also spelled Paroxysmal Nocturnal Hemoglobinuria. It is a hematology treatment studied in patients with PNH, including those with resistance to eculizumab due to complement C5 polymorphisms.
Coversin is being developed by Akari Therapeutics Plc, a biopharmaceutical company listed on the NASDAQ under the ticker symbol AKTX. The company is conducting clinical research on Coversin for the treatment of Paroxysmal Nocturnal Haemoglobinuria (PNH).
Coversin is in Phase 2 clinical development. It has completed two Phase 2 trials for Paroxysmal Nocturnal Haemoglobinuria (PNH), one in the Netherlands and one in the United States. Coversin is investigational and has not been approved by regulatory authorities.
Coversin has completed two Phase 2 clinical trials. The first, NCT02591862, studied Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH) in the Netherlands. The second, NCT03427060, studied Coversin in PNH patients with resistance to eculizumab due to complement C5 polymorphisms in the United States.
No, Coversin is not the same as eculizumab. Coversin is a separate investigational small molecule being developed by Akari Therapeutics. One of its clinical trials specifically enrolled PNH patients who had resistance to eculizumab, indicating that Coversin is being studied as a potential alternative for such patients.