Drugs / RLYB116
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06797375 | Apr 2025 → Feb 2026 | autoimmune disease, hematologic disorder | Rallybio | Completed | Met primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-02-17 | Affibody | Results Affibody’s licensee Rallybio Announces Positive Data for RLYB116 Phase 1 Study Demonstrating Complete and Sustained Inhibition of Terminal Complement affibody.se ↗
Rallybio Corporation (Rallybio) has today announced positive results from its Phase 1 confirmatory pharmacokinetic/pharmacodynamic (PK/PD) clinical study evaluating RLYB116, an innovative, once-weekly, small volume, subcutaneously injected complement factor 5 (C5) inhibitor, based on the Affibody® platform. |
| 2023-12-20 | Affibody | Results Affibody’s Licensee Rallybio Announces Preliminary Phase 1 MAD Data for RLYB116 affibody.se ↗
A 100 mg low volume (1 mL) once-a-week dose of subcutaneously administered RLYB116 achieved sustained mean reductions in free C5 of greater than 93%, including at Day 29 with measurement prior to the last dose. |
| 2023-09-03 | Affibody | Results Affibody’s Partner Rallybio Presents Phase 1 Results at the 29th International Complement Workshop (ICW 2023) affibody.se ↗
Affibody’s partner Rallybio Corporation (Nasdaq: RLYB) today presented results from the Phase 1 first-in-human clinical study of RLYB116 as a poster at ICW 2023 in Newcastle, UK. |
| 2022-11-07 | Affibody | Results Affibody’s partner Rallybio Announces Positive Phase 1 Results for RLYB116 affibody.se ↗
Affibody’s licensee Rallybio Corporation (Nasdaq: RLYB), has announced positive topline results from a Phase 1 single ascending dose (SAD) study in healthy participants of RLYB116. |
All press releases naming this drug 5 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RLYB116 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06797375 ↗ |
| Action | Inhibit | “inhibiting terminal complement activation” NCT06797375 ↗ |
| Modality | Protein / enzyme biologic | “a small protein composed of an Affibody® Z-domain” NCT06797375 ↗ |
| Target | C5 | “binds with high affinity to C5” NCT06797375 ↗ |