Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VIT-2763 · 1 trial · 1 indication
Mean change from baseline in haemolysis markers was measured by reduction of indirect bilirubin.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Participants receive VIT-2763 60 mg, twice a day during 8 weeks. |
| Cohort 2 | EXPERIMENTAL | Participants receive VIT-2763 120 mg, twice a day during 8 weeks. |
| Cohort 3 | EXPERIMENTAL | Participants receive VIT-2763 120 mg, three times a day during 8 weeks. |
| Cohort 4a | PLACEBO_COMPARATOR | Participants receive a placebo, twice a day during 8 weeks. |
| Cohort 4b | PLACEBO_COMPARATOR | Participants receive a placebo, three times a day during 8 weeks. |
| Name | Type | Description |
|---|---|---|
| VIT-2763 120 mg | DRUG | Participants receive 2 capsules of VIT-2763 30 mg in the morning and in the evening, for 8 weeks. Capsules are to be taken orally. |
| VIT-2763 360 mg | DRUG | Participants receive 2 capsules of VIT-2763 60 mg in the morning, in the afternoon and in the evening for 8 weeks. Capsules are to be taken orally. |
| VIT-2763 240 mg | DRUG | Participants receive 2 capsules of VIT-2763 60 mg in the morning and in the evening, for 8 weeks. Capsules are to be taken orally. |
| Placebo BID | DRUG | Participants receive 2 capsules of placebo in the morning and in the evening, for 8 weeks. Capsules are to be taken orally. |
| Placebo TID | DRUG | Participants receive 2 capsules of Placebo in the morning, in the afternoon and in the evening, for 8 weeks. Capsules are to be taken orally. |
Inclusion Criteria: * Male or female subjects with confirmed diagnosis of SCD, including only HbS/S or HbS/βT0 genotype. * Subjects who had at least 1 and no more than 10 vaso-occlusive crises (VOC) episodes reported within 12 months prior to screening. * Body weight ≥40 kg and ≤120 kg at screening...
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| Novo Nordisk A/S Sponsored ADR Class B | NVO | 6 | PHASE3 | Etavopivat |
| Novartis AG Sponsored ADR | NVS | 4 | PHASE3 | Crizanlizumab, OTQ923, ITU512 |
| Agios Pharmaceuticals, Inc. | AGIO | 3 | PHASE3 | Mitapivat, Tebapivat |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE3 | PCV21, Rilzabrutinib |
| Vertex Pharmaceuticals Incorporated | VRTX | 3 | PHASE3 | CTX001 |
| Pfizer Inc. | PFE | 1 | PHASE2 | Osivelotor |
| Travere Therapeutics, Inc. | TVTX | 1 | PHASE3 | L-Citrulline |
| Bristol-Myers Squibb Company | BMY | 1 | PHASE1 | BMS-986470 |
| Beam Therapeutics, Inc. | BEAM | 2 | PHASE1 | BEAM-101 |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-3405 |
| Editas Medicine, Inc. | EDIT | 2 | PHASE1 | EDIT-301 |