DS-1211 / Daiichi Sankyo - LARVOL DELTA

A Study of DS-1211b in Individuals With PseudoXanthoma Elasticum (clinicaltrials.gov) - P2 | N=64 | Completed | Sponsor: Daiichi Sankyo | Active, not recruiting ➔ Completed | Trial completion date: Apr 2024 ➔ Nov 2023 | Trial primary completion date: Apr 2024 ➔ Nov 2023

Trial completion • Trial completion date • Trial primary completion date

A Study of DS-1211b in Individuals With PseudoXanthoma Elasticum (clinicaltrials.gov) - P2 | N=65 | Active, not recruiting | Sponsor: Daiichi Sankyo, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2023 ➔ Apr 2024 | Trial primary completion date: Aug 2023 ➔ Apr 2024

Enrollment closed • Trial completion date • Trial primary completion date

Anticalcification effects of DS-1211 in pseudoxanthoma elasticum mouse models and the role of tissue-nonspecific alkaline phosphatase in ABCC6-deficient ectopic calcification. (PubMed, Sci Rep) - "TNAP plays an active role in pathomechanistic pathways of dysregulated calcification, demonstrated by reduced ectopic calcification in mice with lower TNAP activity. DS-1211 may be a potential therapeutic drug for PXE."

Journal • Preclinical • ABCC6

A Study of DS-1211b in Individuals With PseudoXanthoma Elasticum (clinicaltrials.gov) - P2 | N=64 | Recruiting | Sponsor: Daiichi Sankyo, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

A Study of DS-1211b in Individuals With PseudoXanthoma Elasticum (clinicaltrials.gov) - P2 | N=64 | Not yet recruiting | Sponsor: Daiichi Sankyo, Inc.

New P2 trial

In vitro and in vivo pharmacological profiles of DS-1211, a novel potent, selective, and orally bioavailable tissue-nonspecific alkaline phosphatase inhibitor. (PubMed, J Bone Miner Res) - "Overall, in vitro and in vivo studies showed DS-1211 is a potent and selective TNAP inhibitor across species. Further in vivo pharmacology studies in ectopic calcification animal models and clinical investigations of DS-1211 in patient populations are warranted."

Journal • Preclinical

A Study of DS-1211b in Individuals With PseudoXanthoma Elasticum (clinicaltrialsregister.eu) - P2 | N=64 | Ongoing | Sponsor: Clinical Director, Daiichi Sankyo, Inc.

New P2 trial

Phase I studies of the safety, tolerability, pharmacokinetics, and pharmacodynamics of DS-1211, a tissue-nonspecific alkaline phosphatase inhibitor. (PubMed, Clin Transl Sci) - "Post-treatment PD assessments were consistent with exposure-dependent TNAP inhibition. These data support further evaluation of DS-1211 for ectopic calcification diseases."

Clinical • Journal • P1 data • PK/PD data