Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RHB-104 · 2 trials · 2 indications
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 | ACTIVE_COMPARATOR | 5 RHB-104 capsules administered orally BID |
| Placebo | PLACEBO_COMPARATOR | 5 placebo capsules administered orally BID |
| Name | Type | Description |
|---|---|---|
| RHB-104 | DRUG | 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine |
| Placebo | DRUG | 5 placebo capsules administered orally BID |
Inclusion Criteria 1. Signed fully informed consent provided as per this protocol. 2. Diagnosis of Crohn's Disease confirmed by endoscopy or radiography and/or histology at least 6 months prior to randomization into the study. 3. CD involving the ileum and/or colon 4. Moderately to severely active ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 6 | PHASE3 | Duvakitug |
| Eli Lilly and Company | LLY | 8 | PHASE3 | Mirikizumab |
| AbbVie, Inc. | ABBV | 14 | PHASE3 | Risankizumab, Risankizumab On-Body Injector |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 16 | PHASE3 | Vedolizumab |
| Johnson & Johnson | JNJ | 13 | PHASE3 | Ustekinumab |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Tulisokibart |
| AstraZeneca PLC | AZN | 2 | PHASE2 | AZD7798 |
| Abivax SA Sponsored ADR | ABVX | 1 | PHASE2 | Obefazimod |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY001, SPY002, SPY003 |
| Palisade Bio, Inc. | PALI | 1 | PHASE1 | PALI-2108 |
| Novartis AG Sponsored ADR | NVS | 1 | - | Undisclosed |
| Amgen Inc. | AMGN | 1 | N/A | Undisclosed |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
RHB-104 is an investigational small molecule being studied for Crohn's Disease and Relapsing Remitting Multiple Sclerosis. It is developed by Redhill Biopharma Ltd. (RDHL). In Crohn's Disease, it has completed a Phase 3 trial, while in Relapsing Remitting Multiple Sclerosis it has completed a Phase 2 proof-of-concept study.
RHB-104 is a small molecule antibiotic combination that targets Mycobacterium avium subspecies paratuberculosis (MAP), a bacterium hypothesized to play a role in Crohn's Disease. By inhibiting MAP, RHB-104 aims to address the underlying infectious trigger. This mechanism is being evaluated in clinical trials for both Crohn's Disease and Relapsing Remitting Multiple Sclerosis.
RHB-104 is developed by Redhill Biopharma Ltd., a biopharmaceutical company traded under the ticker RDHL. The company is conducting clinical trials to evaluate RHB-104 for Crohn's Disease and Relapsing Remitting Multiple Sclerosis. Redhill Biopharma is responsible for the drug's development and regulatory strategy.
RHB-104 is in Phase 3 clinical development for Crohn's Disease, with a completed Phase 3 trial (NCT01951326). For Relapsing Remitting Multiple Sclerosis, it has completed a Phase 2 proof-of-concept study (NCT01717664). RHB-104 is investigational and not yet approved by regulatory authorities.
RHB-104 has completed two clinical trials. NCT01951326 was a Phase 3, randomized, double-blind, placebo-controlled study in 331 adults with Crohn's Disease across multiple countries. NCT01717664 was a Phase 2 proof-of-concept study of RHB-104 as add-on therapy to interferon beta-1a in 18 patients with Relapsing Remitting Multiple Sclerosis in Israel.
RHB-104 is a fixed-dose combination of three antibiotics: clarithromycin, rifabutin, and clofazimine. This combination is designed to target Mycobacterium avium subspecies paratuberculosis (MAP). It is being studied as an anti-MAP therapy for Crohn's Disease and Relapsing Remitting Multiple Sclerosis.