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

MUNICH, Germany I October 17, 2024 I 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 autoimmunediseases and potentially other indications by simultaneously blocking several pro-inflammatoryand disease-driving pathways. The highly selective engagement of iRhom2 is expectedto lead to superior efficacy compared to currently available treatments while preservingother vital functions of iRhom2’s interaction partner TACE/ADAM17, which should contributeto a favorable safety profile.

About iRhom2

TACE (TNF-alpha converting enzyme, also known as ADAM17) controls several major signaling pathways, including TNF-alpha, IL-6R, and EGFR signaling. TACE is therefore widely accepted as a potential target to block pro-inflammatory pathways, but direct inhibition of TACE causes severe side effects. The more recent discovery that iRhom2 (inactive Rhomboid 2, RHBDF2) simultaneously and very specifically regulates the TACE-dependent release of TNF-alpha and other pro-inflammatory molecules from immune cells provides the exciting opportunity to target the disease-driving activities of TACE while preserving its other vital functions. Given the pivotal role of iRhom2, numerous new research studies have recently highlighted the therapeutic potential of targeting iRhom2 to treat immunological and inflammatory diseases and beyond, including oncological, infectious, and metabolic diseases.

About SciRhom GmbH

At SciRhom, we are translating world-leading expertise in the TACE/ADAM17 pathway and its central role in autoimmunity and other indications into breakthrough biopharmaceuticals. We are developing proprietary and first-in-class iRhom2-targeting therapies and are accelerating our lead antibody program SR-878 into and through clinical development. With strong support from international lead investors Andera Partners, Kurma Partners, Hadean Ventures, MIG Capital, Wellington Partners, as well as Bayern Kapital and current shareholders, SciRhom aims to push the boundaries in autoimmune medicine.

For further information, please visit www.SciRhom.com

SOURCE: SciRhom