Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RHB-104 · 3 trials · 3 indications
The number of patients who achieved a reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150 points. Lower CDAI scores indicate a better outcome.
Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150. Lower CDAI scores indicate a better outcome.
| Arm | Type | Description |
|---|---|---|
| RHB-104 - patients on ACTIVE therapy in RHB-104-01 study | EXPERIMENTAL | Subjects who were on the active therapy arm in the RHB-104-01 clinical study will continue to receive RHB-104 at 5 capsules twice a day in addition to the standard of care they received in the RHB-104-01 clinical study |
| RHB-104 - patients on PLACEBO therapy in RHB-104-01 study | EXPERIMENTAL | Subjects who were on the active therapy arm in the RHB-104-01 clinical study will receive RHB-104 at 5 capsules twice a day in addition to the standard of care they received in the RHB-104-01 clinical study. The RHB-104 will be ramped up beginning at 1 capsule twice per day in week 1 increasing to 2 capsules twice per day in week 2, 3 capsules twice per day in week 3, 4 capsules per day in week 4 and achieving 5 capsules per day for the remainder of the study. |
| RHB-104 | ACTIVE_COMPARATOR | 5 RHB-104 capsules administered orally BID |
| Placebo | PLACEBO_COMPARATOR | 5 placebo capsules administered orally BID |
| Name | Type | Description |
|---|---|---|
| RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine) | DRUG | For patients on ACTIVE or PLACEBO in the parent study (RHB-104-01), who were not in remission after 26 weeks |
| RHB-104 | DRUG | 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine |
| Placebo | DRUG | 5 placebo capsules administered orally BID |
Inclusion Criteria: * Signed fully informed consent (ICF) provided as per this protocol. * Participation in RHB-104-01 for 26 weeks, and a Crohn's Disease Activity Index (CDAI) score of ≥ 150 at Visit Week 26. OR * More than 26 weeks, with a CDAI ≥150 at Visit Week 26 and all subsequent visits, a...
Top 15 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 16 | PHASE3 | Upadacitinib, Risankizumab, Lutikizumab, Trosunilimab, ABBV-8736 |
| Eli Lilly and Company | LLY | 7 | PHASE3 | Mirikizumab, Tirzepatide, LY4395089, MORF-057 |
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE3 | Duvakitug, Brivekimig |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 15 | PHASE3 | Vedolizumab, Zasocitinib, Darvadstrocel |
| Johnson & Johnson | JNJ | 24 | PHASE3 | Ustekinumab, Guselkumab, JNJ-78934804, Golimumab, Icotrokinra |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Tulisokibart |
| AstraZeneca PLC | AZN | 2 | PHASE2 | AZD7798 |
| Spyre Therapeutics, Inc | SYRE | 2 | PHASE2 | SPY001, SPY002, SPY003 |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Abivax SA Sponsored ADR | ABVX | 1 | PHASE2 | Obefazimod |
| Shattuck Labs, Inc. | STTK | 1 | PHASE2 | SL-325 |
| AgomAb Therapeutics NV ADR | AGMB | 2 | PHASE2 | Ontunisertib |
| Hoffmann-La Roche | RHHBY | 1 | PHASE2 | Afimkibart |
| Pfizer Inc. | PFE | 1 | PHASE2 | Etrasimod |
| Palisade Bio, Inc. | PALI | 1 | PHASE1 | PALI-2108 |
RHB-104 is an investigational oral small molecule therapy developed by Redhill Biopharma Ltd. (ticker RDHL). It is a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine. It has been studied in Crohn disease and relapsing remitting multiple sclerosis and remains in clinical development.
RHB-104 has been studied for the treatment of Crohn disease and relapsing remitting multiple sclerosis. Its clinical program has focused mainly on Crohn disease, where it was evaluated as anti-MAP therapy in adults. It is investigational and has not been approved for any indication.
RHB-104 is developed by Redhill Biopharma Ltd., which trades under the ticker RDHL. The company is the sponsor of the clinical program studying the fixed-dose combination of clarithromycin, rifabutin, and clofazimine in Crohn disease and relapsing remitting multiple sclerosis.
RHB-104 has reached Phase 3 in Crohn disease, with two completed Phase 3 trials, and was studied in a completed Phase 2 proof of concept trial in relapsing remitting multiple sclerosis. It is an investigational drug and is not approved by the FDA.
RHB-104 has been studied in completed trials including NCT01951326, a Phase 3 trial of anti-MAP therapy in adult Crohn disease with 331 participants, NCT03009396, a Phase 3 open label Crohn disease trial with 54 participants, and NCT01717664, a Phase 2 proof of concept trial in relapsing remitting multiple sclerosis with 18 participants.