Revolutionizing Complement Component 5 Inhibition: Rallybio Unveils Phase 1 Single Ascending Dose Data for RLYB116

Breaking Barriers in Disease Treatment: RLYB116’s Remarkable Journey

NEW HAVEN, Conn.–(BUSINESS WIRE)– Rallybio Corporation (Nasdaq: RLYB), a trailblazing biotech firm dedicated to transforming the lives of patients battling severe and rare diseases, unveils a groundbreaking chapter in the development of RLYB116.

In a poster presentation at the 29th International Complement Workshop (ICW) in Newcastle, UK, Rallybio shared results from the Phase 1 first-in-human single ascending dose (SAD) clinical study of RLYB116—a potential game-changer in the realm of complement-mediated diseases.

The data delivered astonishing revelations: RLYB116, administered as a single dose at 100 mg and 300 mg, achieved maximum exposures exceeding 1 µM and 3 µM, respectively. But the true marvel lay in its impact—a staggering reduction of over 99% in free C5 concentrations, signifying the drug’s potency.

Notably, RLYB116 showcased its gentle side, with subcutaneous administration of 100 mg and 300 mg doses resulting in mild to moderate adverse events, devoid of any drug-related serious adverse events.

Dr. Eric Watsky, Rallybio RLYB116 Program Lead, expressed his optimism, stating, “These single-dose findings further illuminate RLYB116’s potential as a groundbreaking C5 inhibitor, poised to address the unmet medical needs of countless patients. We eagerly anticipate sharing more insights from the Phase 1 multiple ascending dose study and unveiling our indication strategy in the fourth quarter of 2023.”

In the realm of disease treatment, RLYB116’s journey is nothing short of revolutionary, forging a path towards hope and healing for those who need it most.

About Rallybio

Rallybio (NASDAQ: RLYB) is on a relentless mission in the world of biotechnology, aiming to redefine the future of healthcare. At the heart of our journey lies the commitment to develop and bring to the world life-altering therapies, especially tailored for patients battling severe and rare diseases.

Our pipeline boasts a wide array of promising candidates, poised to tackle medical challenges in maternal fetal health, complement dysregulation, hematology, and metabolic disorders. Two of our champions have already entered the clinical stage: RLYB212, a formidable anti-HPA-1a antibody with the power to prevent fetal and neonatal alloimmune thrombocytopenia (FNAIT), and RLYB116, an impressive complement component 5 (C5) inhibitor, offering hope to those affected by complement dysregulation. And there’s more in the works, with several programs in the preclinical development stage.

Our headquarters beat in New Haven, Connecticut, where innovation thrives, and we’re also nurturing potential breakthroughs at the University of Connecticut’s Technology Incubation Program in Farmington, Connecticut.

Rallybio isn’t just a company; it’s a beacon of hope, dedicated to rewriting the narratives of patients in need. Join us on this extraordinary journey to transform lives and shape the future of healthcare.

Forward-Looking Statements

Unlocking the Future: Beyond Words

Within these words lies a glimpse into the future—a future shaped by possibilities, driven by determination, and governed by the quest for transformation. This press release unveils a world of potential, a testament to our unwavering belief in progress.

But these aren’t just words; they’re beacons guiding us forward. They tell of a journey where hope meets science, where innovation is our compass, and where we aim to redefine what’s possible in healthcare.

These statements are more than predictions; they are declarations of intent. They paint a picture of what could be, fueled by the dedication and commitment of a team that sees no limits. Our mission is clear: to bring life-transforming therapies to those who need them most.

As we venture into the unknown, we acknowledge the challenges that lie ahead, but we stand resilient. We are driven to overcome obstacles, to chart new territories, and to inspire change. Our commitment is unwavering, and our vision is clear.

This is more than just a press release; it’s a testament to our ambition, a glimpse into a future that we are determined to shape. Join us on this remarkable journey as we strive to make a difference, one breakthrough at a time.

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