K1-70 / AV7 Limited - LARVOL DELTA

AV7-K1-70-IV-002: Study to Assess K1-70 in Participants with Active Thyroid Eye Disease (clinicaltrialsregister.eu) - P1/2 | N=50 | Not yet recruiting | Sponsor: Av7 Limited

New P1/2 trial • Endocrine Disorders • Grave’s Disease • Ophthalmology • Thyroid Eye Disease

TSH receptor specific monoclonal autoantibody K1-70 targeting of the TSH receptor in subjects with Graves' disease and Graves' orbitopathy - results from a phase I clinical trial: Conclusions. (PubMed, Clin Endocrinol (Oxf)) - "Expected PD effects occurred after a single IM dose of 25mg or single IV dose of 50mg or 150mg with fT3, fT4 and TSH levels progressing into hypothyroid ranges. There were also clinically significant improvements in symptoms of both GD (reduced tremor, improved sleep, improved mental focus, reduced toilet urgency) and GO (reduced exophthalmos measurements, reduced photosensitivity)."

Journal • P1 data • Endocrine Disorders • Immunology • Movement Disorders • Ophthalmology

Blocking the TSH receptor with K1-70™ in a patient with follicular thyroid cancer, Graves’ disease and Graves’ ophthalmopathy. (PubMed, Thyroid) - "On K1-70™ monotherapy during the pause in lenvatinib several metastatic lesions stabilised while others showed progression attenuation compared to that prior to lenvatinib therapy. Conclusions These observations suggest that blocking TSHR stimulation with K1-70™ can be an effective treatment for GO and may also benefit select patients with FTC and GD."

Clinical • Journal • Endocrine Cancer • Endocrine Disorders • Immunology • Inflammation • Oncology • Ophthalmology • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Follicular Carcinoma