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Rallybio Announces Positive Phase 1 Single Ascending Dose Results for RLYB116, an Innovative Subcutaneously Injected Inhibitor of Complement Component 5
-- 100 mg Results Demonstrated a Reduction of >99% in Free C5 with the Potential for Weekly or Less Frequent Self-Administered Dosing -- -- RLYB116
About this update from Rallybio Corporation
[{"type":"text","content":"\n-- 100 mg Results Demonstrated a Reduction of >99% in Free C5 with the Potential for Weekly or Less Frequent Self-Administered Dosing --\n-- RLYB116 Administered as a Single 100 mg dose was Generally Well-Tolerated --\n-- Phase 1 Multiple Ascending Dose Study Expected to Commence in 1Q 2023 --\n\n NEW HAVEN, Conn.--(BUSINESS WIRE)--\nRallybio Corporation (Nasdaq: RLYB) today announced positive topline results from its Phase 1 single ascending dose (SAD) study in healthy participants of RLYB116, an innovative potentially long-acting, subcutaneously injected inhibitor of complement component 5 (C5), in development for the treatment of patients with complement-mediated diseases.\n\nIn the ongoing Phase 1 study, all study participants that were administered a single 1 mL subcutaneous injection of 100 mg of RLYB116 (n=6) 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.\n\n“We are excited by these positive data which suggest the potential for rapid and complete functional blockade of terminal complement activity with a patient-convenient, self-administered 1 mL injection of RLYB116. Pharmacokinetic modeling of these single dose data support the potential for sustained complement inhibition with once-a-week or less frequent dosing, and we believe the possibility of an improved quality of life for patients. We believe that these preliminary results validate RLYB116 as a highly innovative C5 inhibitor with the potential to address significant unmet need for patients with a broad range of complement-mediated diseases,” said Martin Mackay, Ph.D., Chief Executive Officer of Rallybio.\n\nEric Watsky, M.D., Rallybio’s RLYB116 Program Lead added, “The results from this ongoing Phase 1 study support the further development of RLYB116 in patients with a broad range of complement-mediated diseases, with a long half-life and the potential to fully inhibit C5 with a small volume subcutaneous injection. We currently expect to initiate the multiple ascending dose Phase 1 study of RLYB116 in the first quarter of 2023.”\n\nSubcutaneously 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.\n\nAbout the RLYB116 Phase 1 Study\n\n...