RLYB116 / Rallybio, Affibody - LARVOL DELTA

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of RLYB116 in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Rallybio | Active, not recruiting ➔ Completed | Trial completion date: Jun 2026 ➔ Feb 2026

Trial completion • Trial completion date • Hematological Disorders • Immunology

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of RLYB116 in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Rallybio | Recruiting ➔ Active, not recruiting

Enrollment closed • Hematological Disorders • Immunology

Evaluating Clinical Endpoints for C5 Inhibitors (ASH 2024) - "Using free C5 levels as surrogate endpoints in complement therapies, especially for marketed Eculizumab and Ravulizumab, is grounded in the drug's specific mechanism of action and the correlation between free C5 levels and clinical outcomes. Furthermore, based on the totality of data from ex-vivo and clinical results, we conclude that RLYB116 demonstrated comparable or better potency compared to Ravulizumab, with a once weekly/self-administered dose. Additional pharmacodynamic markers, instead of free C5, should be used to support RLYB116 clinical development."

Clinical • Hematological Disorders

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of RLYB116 in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Rallybio | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders • Immunology

First Quarter 2025 Financial Results (Businesswire) - "Research & Development (R&D) Expenses: R&D expenses were $5.7 million for the first quarter of 2025, compared to $12.9 million for the same period in 2024. The decrease in R&D expenses was primarily due to a decrease in development costs related to RLYB212, RLYB116, and other program candidates, in addition to a decrease in payroll and personnel-related costs, largely related to the workforce reduction in the first quarter of 2024."

Commercial • Hematological Disorders • Immunology • Thrombocytopenia

Recent Business Highlights and Upcoming Milestones (Businesswire) - "Rallybio is on track to initiate dosing in the RLYB116 confirmatory clinical pharmacokinetic/pharmacodynamic (PK/PD) study in the second quarter of 2025. Results from Cohort 1 (150 mg once weekly) and Cohort 2 (225 mg once weekly) are anticipated in the third and fourth quarter of 2025, respectively....Investigational new drug application (IND)-enabling studies are underway for REV102, an ENPP1 inhibitor for the treatment of patients with hypophosphatasia (HPP), which is being developed through a joint venture with Recursion Pharmaceuticals. These studies are expected to support the initiation of a Phase 1 study in the second half of 2026; Presentation of data evaluating REV102 in a preclinical model of later-onset HPP is expected in the second half of 2025."

New P1 trial • P1 data • Preclinical • Hematological Disorders • Immunology

Promising Rare Disease Pipeline to Deliver Data in 2H 2025 (Rallybio Press Release) - "Rallybio remains on track to initiate dosing in the RLYB116 confirmatory clinical pharmacokinetic/ pharmacodynamic (PK/PD) study in the second quarter of 2025, with data readouts from Cohorts 1 and 2 expected in the third and fourth quarter of 2025, respectively. The study is expected to demonstrate complete and sustained complement inhibition with improved tolerability of RLYB116...REV102, an ENPP1 inhibitor for the treatment of patients with HPP under development through a joint venture with Recursion Pharmaceuticals, entered investigational new drug application (IND)-enabling studies in the first quarter of 2025 to support the initiation of a Phase 1 study in 2026. Data evaluating REV102 in a preclinical model of later-onset HPP is expected in the second half of 2025....The Company is preparing plans for future development of RLYB332."

Clinical data • New P1 trial • Pipeline update • Preclinical • Myasthenia Gravis • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of RLYB116 in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Rallybio

New P1 trial • Hematological Disorders • Immunology

Rallybio Highlights 2024 Accomplishments and Anticipated Milestones for 2025 (Businesswire) - "Anticipated 2025 Key Milestones: RLYB116: i) Initiate confirmatory clinical PK/PD study in the second quarter of 2025; ii) Cohort 1 data readout from clinical PK/PD study in the third quarter of 2025; iii) Cohort 2 data readout from clinical PK/PD study in the fourth quarter of 2025."

New trial • P1 data • Hematological Disorders

First-in-Human Study of RLYB116 in Healthy Participants (ANZCTR) - P1 | N=88 | Completed | Sponsor: IPC Research, LLC | Recruiting ➔ Completed

Trial completion