SciRhom Gets Approval for First iRhom2 Antibody Trial for Autoimmune Diseases

On June 12, 2024, in Munich, Germany, SciRhom GmbH, an innovative biopharmaceutical company, announced the approval of a clinical trial application (CTA) by Austrian regulatory authorities (BASG/AGES). This approval pertains to SciRhom's development program SR-878. The forthcoming clinical study is designed to assess the safety of SR-878, a proprietary monoclonal antibody targeting iRhom2, in healthy volunteers. The study also aims to provide preliminary evidence of clinical activity. SciRhom plans to commence the first dosing of participants in the latter half of 2024.

Dr. Jan Poth, Managing Director & CEO of SciRhom, stated, "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."

Dr. Jens Ruhe, Managing Director & COO of SciRhom, added, "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."

The molecule iRhom2 is a key regulator of TACE/ADAM-17, which is a master switch for numerous disease-relevant signaling pathways. SR-878 was specifically designed to inhibit multiple pathways simultaneously, including TNF-alpha and IL-6R signaling. In preclinical models of rheumatoid arthritis (RA) and inflammatory bowel disease (IBD), SR-878 has shown its ability to selectively and potently inhibit TACE activity in immune cells. This inhibition facilitates tissue regeneration and re-balances the immune system. As a monotherapy, SR-878 exhibited superior preclinical efficacy compared to individually used approved drugs for autoimmune disorders. Furthermore, toxicological assessments of SR-878 have supported the anticipated favorable safety profile of this therapeutic approach.

TACE (TNF-alpha converting enzyme, also known as ADAM-17) is involved in regulating several major signaling pathways, including TNF-alpha, IL-6R, and EGFR signaling. While TACE is considered a potential target for blocking pro-inflammatory pathways, its direct inhibition can lead to severe side effects. The recent discovery that iRhom2, also known as inactive Rhomboid 2 (RHBDF2), regulates the TACE-dependent release of TNF-alpha and other pro-inflammatory molecules from immune cells provides an exciting therapeutic opportunity. Targeting iRhom2 can inhibit the pro-inflammatory activities of TACE while preserving its essential functions. This pivotal role of iRhom2 has led to numerous research studies underscoring its therapeutic potential in treating not only immunological and inflammatory diseases but also oncological, infectious, and metabolic diseases.

SciRhom is driven by translating leading expertise in the TACE/ADAM-17 pathway into groundbreaking biopharmaceuticals. By developing proprietary and first-in-class iRhom2-targeting therapies, SciRhom is advancing its lead antibody program SR-878 into clinical development stages.