Pharma Focus America

Rallybio Unveils Phase 1 Single Ascending Dose Findings for RLYB116, an Innovative Subcutaneous Inhibitor Targeting Complement Component 5

Monday, September 04, 2023

Rallybio Corporation, listed on Nasdaq as RLYB, is a clinical-stage biotechnology company with a strong commitment to identifying and expediting the development of transformative therapies for individuals suffering from severe and rare diseases. The company recently shared clinical data through a poster presentation at the 29th International Complement Workshop (ICW) in Newcastle, UK. This data stems from the Phase 1 clinical study, marking the first-ever administration of a single ascending dose (SAD) of RLYB116 to healthy participants. RLYB116 is a novel, potentially long-lasting drug designed for subcutaneous injection, aiming to inhibit C5, and is currently undergoing development for the treatment of patients with diseases mediated by the complement system.

The disclosed findings in the poster demonstrate that a single dose of RLYB116, particularly at the higher doses of 100 mg and 300 mg, resulted in peak concentrations exceeding 1 µM and 3 µM, respectively. Furthermore, it achieved a remarkable reduction of over 99% in free C5 concentrations. Significantly, the subcutaneous administration of RLYB116 at either 100 mg or 300 mg proved to be well-tolerated among participants, with reported mild to moderate adverse events and an absence of drug-related serious adverse events.

Dr. Eric Watsky, who leads the RLYB116 program at Rallybio, expressed his thoughts on these results at the ICW event. He stated, "The findings we've presented today at ICW further strengthen our confidence in the potential utility of RLYB116 for treating a wide spectrum of complement-mediated diseases. These single-dose data hint at RLYB116's potential as a groundbreaking C5 inhibitor, with the capability to address significant unmet medical needs among patients." Dr. Watsky also indicated that the company is on track to release initial data from the Phase 1 multiple ascending dose study of RLYB116 and outline their indication strategy in the fourth quarter of 2023.

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