exenatide SR two week formulation (PT302) / Peptron - 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

What is the report card for developing new drugs for ’incurable’ Parkinson’s disease such as Dong-A ST and Bukwang Pharm? [Google translation] (Consumer News) - "ABL Bio...is developing a new dual antibody drug for Parkinson's disease 'ABL301'....The company plans to apply for Phase 1 in the first half of next year after undergoing preclinical animal model efficacy experiments and additional safety verification steps....PT302 is in phase 2 in Korea, and a recent study proved its efficacy in inhibiting LID progression, a side effect of levodopa."

New P1 trial • Trial status • CNS Disorders • Parkinson's Disease

PT320, Sustained-Release Exendin-4, Mitigates L-DOPA-Induced Dyskinesia in a Rat 6-Hydroxydopamine Model of Parkinson's Disease. (PubMed, Front Neurosci) - "Although PT320 did not alter DA levels in the lesioned striatum, PT320 significantly attenuated 6-OHDA-enhanced DA turnover. PT320 attenuates L-DOPA/benserazide-induced dyskinesia in a 6-OHDA rat model of PD and warrants clinical evaluation to mitigate Parkinson's disease in humans."

Journal • Preclinical • CNS Disorders • Movement Disorders • Parkinson's Disease

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

Small-cavity chamber dose response in megavoltage photon beams coupled to magnetic fields. (PubMed, Phys Med Biol) - "Small-cavity chambers (PTW31010, PTW31016, PTW31021 and PTW3022) are irradiated by a 6 MV photon beam for nine magnetic field strengths between -1.5T and +1.5T...Small differences between real and model chamber geometry that normally would be insignificant become an issue in the presence of magnetic fields. Accurate characterization of the nominal volume is essential for small-cavity ion chamber modelling."

Journal

Pharmacokinetic properties and effects of PT302 after repeated oral glucose loading tests in a dose-escalating study (Clin Ther) - P1, N=34; NCT00964262; "The pharmacodynamic effect of PT302 on the postprandial response of insulin and C-peptide was significant on days 21 to 28 at the 4-mg dose and was positively correlated with plasma exenatide concentrations, whereas the correlations with glucose and glucagon were not significant."

P1 data • Diabetes

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