exenatide SR (DA-3091) / Dong-A - LARVOL DELTA

Pharmacokinetics of Exenatide in nonhuman primates following its administration in the form of sustained-release PT320 and Bydureon. (PubMed, Sci Rep) - "The time-dependent (30 min - day 84) plasma profile of PT320, a sustained-release (SR)-Exenatide formulation under clinical development for treatment of neurodegenerative disorders, was evaluated in nonhuman primates after a single subcutaneous dose and was compared to Bydureon. The former, however, reached and maintained steady-state plasma Exenatide levels more rapidly, without dipping to a sub-therapeutic concentration. Both SR-Exenatide formulations proved well-tolerated and, following a well-regulated initial release burst, generated steady-state plasma levels of Exenatide, but with PT320 producing continuous therapeutic Exenatide levels and more rapidly reaching a steady-state."

Journal • PK/PD data • CNS Disorders

Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation (clinicaltrials.gov) - P2; N=9; Active, not recruiting; Sponsor: Mayo Clinic; Recruiting ➔ Active, not recruiting; N=81 ➔ 9

Clinical • Enrollment change • Enrollment closed • Diabetes • Metabolic Disorders • Renal Disease • Transplantation

SR-Exenatide (PT320) to Eveluate Efficacy and Safety in Patients With Early Parkinson's Disease (clinicaltrials.gov) - P2a; N=99; Recruiting; Sponsor: Peptron, Inc.

Clinical • New P2a trial

Pharmacokinetics and efficacy of PT302, a sustained-release Exenatide formulation, in a murine model of mild traumatic brain injury. (PubMed, Neurobiol Dis) - "In this study, the pharmacokinetics and efficacy of PT302, a clinically available sustained-release Exenatide formulation (SR-Exenatide) were evaluated in a concussive mild (m)TBI mouse model. These data demonstrate a positive beneficial action of PT302 in mTBI. This convenient single, sustained-release dosing regimen also has application for other neurological disorders, such as Alzheimer's disease, Parkinson's disease, multiple system atrophy and multiple sclerosis where prior preclinical studies, likewise, have demonstrated positive Exenatide actions."

Journal • PK/PD data • Preclinical

Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation (clinicaltrials.gov) - P2; N=81; Recruiting; Sponsor: Mayo Clinic

New P2 trial