Therapy Areas: Inflammatory Diseases
Rallybio Touts Positive Phase 1 Single Ascending Dose Results for RLYB116, an Innovative Subcutaneously Injected Inhibitor of Complement Component 5
7 November 2022 - - US-based biotechnology company Rallybio Corp. (NASDAQ: RLYB) has released positive topline results from its Phase 1 single ascending dose study in healthy participants of RLYB116, an innovative potentially long-acting, subcutaneously injected inhibitor of complement component 5, in development for the treatment of patients with complement-mediated diseases, the company said.

In the ongoing Phase 1 study, all study participants that were administered a single 1 mL subcutaneous injection of 100 mg of RLYB116 demonstrated a reduction in free C5 greater than 99% within 24 hours of dosing.

The terminal elimination half-life of RLYB116 was greater than 300 hours.

Subcutaneously administered RLYB116 was observed to be generally well-tolerated at the 100 mg dose, with mild or moderate adverse events and no drug-related serious adverse events reported.

RLYB116 is an innovative, potentially long-acting, subcutaneously injected inhibitor of C5.

The ongoing RLYB116 single-blind, placebo-controlled dose escalation study was initiated in February 2022 and is designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of single subcutaneous dose RLYB116 in healthy participants and includes five dose cohorts (2, 10, 30, 100, 300 mg RLYB116) with each enrolling 8 participants.

Post-treatment / study follow-up is expected to continue for 10 weeks.

Rallybio is a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare diseases.

Since its launch in January 2018, Rallybio has built a portfolio of promising product candidates, which are now in development to address rare diseases in the areas of hematology, immuno-inflammation, maternal fetal health, and metabolic disorders.

The company's mission is being advanced by a team of highly experienced biopharma industry leaders with extensive research, development, and rare disease expertise.

Rallybio is headquartered in New Haven, Connecticut, with an additional facility at the University of Connecticut's Technology Incubation Program in Farmington, Connecticut.
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