Transition into clinical-stage development marks a significant corporate and R&D milestone

Munich, Germany, October 17, 2024 – SciRhom GmbH, a biopharmaceutical company pioneering the development of first-in-class therapeutic iRhom2 antibodies, today announced that the dosing of participants has commenced in the first clinical study evaluating the company’s most advanced development program SR-878. The first-in-human, double-blind, placebo-controlled, single ascending dose study will assess the safety, tolerability, pharmacokinetic, and pharmacodynamic effects of SR-878 in up to 48 healthy volunteers. SciRhom is conducting the study in collaboration with the Department of Clinical Pharmacology at the Medical University of Vienna, Austria. The study is expected to read out in H2 2025.

“Initiating the first clinical study with our iRhom2-targeting approach represents a transformational milestone and value inflection point for the company. Our goal is to underpin the favorable safety profile of SR-878 observed in preclinical studies, and progress swiftly toward demonstrating the clinical benefits of our novel approach in patients in the subsequent Phase 2 trials,” commented Dr. Jürgen Reess, CMO of SciRhom.

Dr. Jan Poth, Managing Director & CEO of SciRhom added: “Today’s exciting event brings us closer than ever before to demonstrating the breakthrough potential of targeting iRhom2 and thereby modulating the disease-relevant pathways controlled by TACE/ADAM17. We are very happy that we could engage the Department of Clinical Pharmacology at the Medical University of Vienna for this first study in humans, whose expertise will be very valuable in establishing a solid foundation for potentially multiple subsequent studies.”

With its SR-878 program, SciRhom aims to provide a new treatment paradigm for autoimmune diseases and potentially other indications by simultaneously blocking several pro-inflammatory and disease-driving pathways. The highly selective engagement of iRhom2 is expected to lead to superior efficacy compared to currently available treatments while preserving other vital functions of iRhom2’s interaction partner TACE/ADAM17, which should contribute to a favorable safety profile.