SciRhom GmbH, a biopharmaceutical company pioneering the development of first-in-class therapeutic antibodies, announced the approval of a clinical trial application (CTA) by the Austrian regulatory authorities (BASG/AGES) for its development program SR-878. The upcoming clinical study aims to evaluate safety in healthy volunteers for the proprietary iRhom2-targeting monoclonal antibody SR-878 and provide initial evidence of clinical activity in a second part of the study. SciRhom expects to initiate the first dosing of study participants in the second half of 2024.

„We are entering a transformative period for SciRhom with our first-in-class antibody program SR-878 accelerating towards clinical studies. In parallel to transitioning into a clinical-stage drug development organization, SciRhom has established a comprehensive preclinical pharmacology and toxicology data package for the lead development program, a robust and efficient manufacturing process, and secured broad patent protection for iRhom2-targeting therapeutic strategies”, commented Dr. Jan Poth, Managing Director & CEO of SciRhom.

„Today’s news is a testament to the high-quality standards and joint efforts invested by SciRhom’s team and our network partners over an extended period of time. The resulting CTA package built the basis for a productive interaction with the regulatory authorities and its approval brings us one step closer to evaluating our first therapeutic candidate in human studies. I want to thank everyone who has contributed to this development milestone”, added Dr. Jens Ruhe, Managing Director & COO of SciRhom.

The target molecule iRhom2 acts as a crucial regulator of TACE/ADAM-17, a master switch for various disease-relevant signaling pathways. SR-878 was designed to simultaneously block several of these pathways, including TNF-alpha and IL-6R signaling. In preclinical models of rheumatoid arthritis (RA) and inflammatory bowel disease (IBD), SR-878 has demonstrated its ability to inhibit TACE activity potently and selectively in immune cells, facilitating tissue regeneration and immune re-balancing. In these preclinical studies, SR-878 as a monotherapy showed superior preclinical efficacy over individually used approved drugs for autoimmune disorders. Moreover, the toxicological assessment of SR-878 supported the expected favorable safety profile of the approach.