Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PRM-151 · 3 trials · 2 indications
Determine the effect size of PRM-151 relative to placebo in change from Baseline to Week 28 in mean FVC% predicted, pooling subjects on a stable dose of pirfenidone or nintedanib with subjects not on other treatment for IPF.
Number of adverse events (AEs), treatment emergent adverse events (TEAEs), non-ocular TEAEs, Ocular TEAEs, serious adverse events (SAEs), abnormal slit-lamp biomicroscopic findings, and abnormal dilated fundoscopy findings
The number of Subjects with AEs, TEAEs, SAEs, decreased visual acuity, and worsened visual fields
Number of subjects with Dose Limiting Toxicities, Number of Treatment Emergent Serious Adverse Events and Adverse Events
| Arm | Type | Description |
|---|---|---|
| PRM-151 10mg / kg | EXPERIMENTAL | Dosing Every 4 Weeks |
| Placebo | PLACEBO_COMPARATOR | Dosing Every 4 weeks |
| PRM-151 | EXPERIMENTAL | PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2) |
| Name | Type | Description |
|---|---|---|
| PRM-151 | BIOLOGICAL | PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks |
| placebo | OTHER | Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks |
Inclusion Criteria 1. Is aged 40-80 years. 2. Has IPF satisfying the American Thoracic Society/European Respiratory Society /Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) diagnostic criteria (Raghu, Collard et al. 2011). In the absence of a surgical lung biopsy...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Glaukos Corp | GKOS | 6 | PHASE3 | Gen 2 Travoprost Intracameral, Timolol eye 0.5% |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Undisclosed |
| SpyGlass Pharma, Inc. | SGP | 4 | PHASE3 | Bimatoprost System, Timolol, 0.5% |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 2 | PHASE3 | Test- Bimatoprost 0.01%, Reference- LUMIGAN |
| Alcon AG | ALC | 5 | N/A | Undisclosed |
| Sight Sciences, Inc. | SGHT | 3 | N/A | Undisclosed |
PRM-151 is an investigational small molecule being studied for glaucoma and idiopathic pulmonary fibrosis (IPF). In glaucoma, it was evaluated for preventing scarring following trabeculectomy surgery. In IPF, it was studied as a potential treatment for the progressive lung disease. PRM-151 is not approved and remains in clinical development.
PRM-151 is being developed by Roche Holding AG, traded on the OTC market under the ticker RHHBY. Roche is a multinational healthcare company. The drug is an investigational small molecule in Phase 2 clinical development for ophthalmology and pulmonary indications.
PRM-151 is in Phase 2 clinical development. It has completed two Phase 2 trials, one in glaucoma and one in idiopathic pulmonary fibrosis, as well as a Phase 1 trial in IPF. The drug is investigational and has not received FDA approval.
PRM-151 has been studied in three completed trials. NCT01064817 was a Phase 2 trial in 124 glaucoma patients across Belgium, Czechia, Netherlands, and the UK. NCT01254409 was a Phase 1b trial in 21 IPF patients in the US and Netherlands. NCT02550873 was a Phase 2 trial in 117 IPF patients across multiple countries.
PRM-151 is the primary name for this investigational drug. No alternative names have been reported in the clinical trial data. It is a small molecule being developed by Roche for glaucoma and idiopathic pulmonary fibrosis, and it is not yet approved for any use.