Roche's Potential First-in-Class OSMRβ-Targeting Antibody Vixarelimab Granted IND Approval in China for Ulcerative Colitis

On May 22, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced,Roche's Genentech Submits New Drug Application for Class 1 Drug vIxarelimab Injection Approved for Clinical Trials, Intended for Development in TreatmentUlcerative Colitis. According to public information, vIxarelimab (RG6536) isA Potential "First-in-Class" BlockerOSMRβA fully human monoclonal antibody, currently in phase 2 clinical trials internationally.

Screenshot source: CDE official website

Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) thatCausing Chronic Inflammation of the Gastrointestinal TractPatients may experience symptoms such as diarrhea, abdominal pain, bloody stools, rectal bleeding, weight loss, and fatigue. Ulcerative colitis significantly impacts the quality of life for patients, who are also in urgent need of safer and more effective treatment options.

Currently, researchers have alreadyObserved in a variety of human diseasesOncostatin M and its receptor β（OSM/OSMRβ）Dysregulation,And may drive in the affected tissuesFibrosis, Inflammation, and Itchingand other pathological processes. ExistingThe research findings revealed OSM as a potential target for pruritus neuromodulation and anti-itch treatment.

Vixarelimab is a selectiveOSMRβTargeted fully human monoclonal antibody, itCan block OSM and IL-31 signaling while preserving signaling through the LIFR pathway.The ProductThe Phase 2a clinical trial for the treatment of prurigo nodularis has previously met its primary endpoint and received Breakthrough Therapy Designation from the U.S. FDA for the treatment of itching associated with prurigo nodularis.

In August 2022, Kiniksa Pharmaceuticals reached an agreement with Roche and GenentechCooperationThe latter obtained a global license for the development and commercialization rights of vixarelimab, and Kiniksa received a total of 100 million US dollars in upfront and near-term payments.

According to Roche's official website andClinicalTrialsAccording to the official website, vixarelimab is being targeted forModerate to Severe Ulcerative ColitisA Phase 2 clinical study has been initiated. In addition, Phase 2 clinical trials are also being conducted for prurigo nodularis, idiopathic pulmonary fibrosis, and interstitial lung disease associated with systemic sclerosis.

References:

[1] Official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Retrieved May 22，2024, From https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

[2]Kiniksa Pharmaceuticals Announces Global License Agreement with Genentech for Vixarelimab. Retrieved August 3, 2022 from https://investors.kiniksa.com/news-releases/news-release-details/kiniksa-pharmaceuticals-announces-global-license-agreement

[3]Itch receptor OSMR attracts industry. (2022)Nat Biotechnol. https://doi.org/10.1038/s41587-022-01481-1