ASP1617 / Astellas - LARVOL DELTA

Development of a novel Poly (I:C)-induced murine model with accelerated lupus nephritis and examination of the therapeutic effects of mycophenolate mofetil and a cathepsin S inhibitor. (PubMed, Eur J Pharmacol) - "Systemic lupus erythematosus (SLE) is an autoimmune disease involving multi-organ systems with a widely heterogeneous clinical presentation. The cathepsin S (CatS) inhibitor ASP1617, which has been reported to prevent development of lupus-like glomerulonephritis in the spontaneous NZB/W F1 mouse model, also showed marked therapeutic effect in this model. Our novel Poly (I:C) accelerated LN model would thus be very useful for screening clinical candidates for LN, and CatS may be an attractive therapeutic target for the treatment of LN."

Journal • Preclinical • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Systemic Lupus Erythematosus • CTSS

Potential benefit of the cathepsin S inhibitor, ASP1617, as a treatment for systemic lupus erythematosus. (PubMed, Eur J Pharmacol) - "We investigated the effects of ASP1617 and mycophenolate mofetil (MMF) on the development of lupus-like nephritis in NZB/W F1 mice, a widely used SLE mouse model. Further, we found that plasma and/or urine CatS levels were increased in specimens from NZB/W F1 mice and several SLE patients. These results indicate that CatS may be an attractive therapeutic target for the treatment of SLE."

Journal • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Systemic Lupus Erythematosus • CTSS

Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1617 in Healthy Adult Non-Asian and Japanese Subjects Including Assessment of a Food Effect (clinicaltrials.gov) - P1; N=97; Completed; Sponsor: Astellas Pharma Global Development, Inc.; Recruiting ➔ Completed

Clinical • Trial completion

Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1617 in Healthy Adult Non-Asian and Japanese Subjects Including Assessment of a Food Effect (clinicaltrials.gov) - P1; N=97; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Trial completion date: Feb 2021 ➔ May 2021; Trial primary completion date: Feb 2021 ➔ May 2021

Clinical • Trial completion date • Trial primary completion date

Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1617 in Healthy Adult Non-Asian and Japanese Subjects Including Assessment of a Food Effect (clinicaltrials.gov) - P1; N=97; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Suspended ➔ Recruiting; Trial completion date: Sep 2020 ➔ Feb 2021; Trial primary completion date: Sep 2020 ➔ Feb 2021

Clinical • Enrollment open • Trial completion date • Trial primary completion date

Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1617 in Healthy Adult Non-Asian and Japanese Subjects Including Assessment of a Food Effect (clinicaltrials.gov) - P1; N=97; Suspended; Sponsor: Astellas Pharma Global Development, Inc.; Trial completion date: May 2020 ➔ Sep 2020; Recruiting ➔ Suspended; Trial primary completion date: May 2020 ➔ Sep 2020

Clinical • Trial completion date • Trial primary completion date • Trial suspension

Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1617 in Healthy Adult Non-Asian and Japanese Subjects Including Assessment of a Food Effect (clinicaltrials.gov) - P1; N=88; Recruiting; Sponsor: Astellas Pharma Global Development, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open