RallyBio Announces Phase 1 Initiation with RLYB116

Solna, Sweden, March 7, 2022. Affibody’s licensee Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare diseases, has announced the initiation of a Phase 1 study with RLYB116.

RLYB116 is an Affibody® molecule attached to an albumin binding domain that has the potential to drive the rapid, complete, and sustained inhibition of C5 with a subcutaneous injection. The molecule was initially developed by Affibody under a collaboration with Sobi.

“Initiating clinical trials with RLYB116 is a great achievement for our collaborators at RallyBio and we congratulate them for it”, says Prof. Fredrik Frejd, CSO of Affibody. “The small size and the potential for long circulatory half-life makes Affibody® molecules ideally suited for treatment of complement mediated diseases that generally require high drug doses”.

The Phase 1 trial with RLYB116 will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic activity of RLYB116 following subcutaneous administration. The trial is planned to enroll up to 48 participants for single dose administration and to evaluate up to 6 single ascending dose levels.

About RLYB116
RLYB116 is a novel, potentially long-acting, subcutaneously administered inhibitor of complement factor 5, or C5, in development for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) and generalized Myasthenia Gravis (gMG). Single dose safety, PK, and pharmacodynamic data from this Phase 1 study are expected in the second half of 2022.

About RallyBio
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.

Further information can be found at: www.rallybio.com.

About Affibody
Affibody is a clinical stage biopharmaceutical company with a broad product pipeline focused on developing innovative bi- and multi-specific next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody® molecules and Albumod®.

Affibody AB is a holding of Patricia Industries.

Further information can be found at: www.affibody.com