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Scholar Rock Announces Publication of Preclinical Pharmacology, Pharmacokinetics, and Safety Profile of SRK-181 in the International Journal of Toxicology

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in

articleScholar Rock Holding CorporationMarch 22, 20213/company/scholar-rock-holding-corp/news/scholar-rock-announces-publication-of-preclinical-pharmacology-pharmacokinetics-and
Scholar Rock Announces Publication of Preclinical Pharmacology, Pharmacokinetics, and Safety Profile of SRK-181 in the International Journal of Toxicology

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[{"type":"text","content":" CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nScholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, today announced the publication of preclinical development data for SRK-181 in the peer-reviewed journal International Journal of Toxicology. SRK-181 is a product candidate that has been shown to be a potent and highly specific inhibitor of latent growth factor-beta 1 (TGFβ1) activation in preclinical studies. SRK-181 is being developed to overcome primary resistance to checkpoint inhibitor therapy and is currently being studied in the two-part DRAGON Phase 1 trial in patients with locally advanced or metastatic solid tumors exhibiting primary resistance to anti-PD-(L)1 therapy.\n\n“This publication provides a comprehensive preclinical assessment of the pharmacology, pharmacokinetics, and safety of SRK-181, which support its evaluation in the DRAGON Phase 1 trial,” said Gregory Carven, Ph.D., Chief Scientific Officer of Scholar Rock. “The initial clinical response and safety data from the DRAGON trial, which we anticipate by end of year, will provide an early look into SRK-181’s safety and tolerability profile and the potential for a specific inhibitor of latent TGFβ1 to overcome the immune exclusion that we believe, for many patients, is responsible for primary resistance to checkpoint inhibitor therapies.”\n\nTargeting the TGFβ1 Pathway\n\nGreater understanding of the role of TGFβ signaling in promoting cancer progression has led to heightened interest in the development of therapies that inhibit the TGFβ pathway. However, most of the approaches to date have been non-selective and target at least two of the three TGFβ isoforms, which may limit the therapeutic window and potentially result in a lack of efficacy, an unfavorable safety profile, or a combination of the two. Examples of dose-limiting toxicities observed nonclinically for nonselective anti-TGFβ therapies include cardiovascular abnormalities, skin lesions, epithelial oral hyperplasia, and gingival bleeding.\n\nScholar Rock’s approach to targeting the TGFβ pathway is fundamentally different. SRK-181 is a highly specific inhibitor of the latent TGFβ1 isoform with minimal or no binding to latent TGFβ2, latent TGFβ3, or any of the active TGFβ growth factors based...

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