Pain Therapeutics, Inc. (NASDAQ:PTIE) reported the completion of a Phase 1 clinical trial for PTI-125, which is an experimental drug therapy to cure Alzheimer’s Disease. This trial assessed for the first time the dosing, pharmacokinetic profile and safety of PTI-125 in healthy subjects.
PTI-125 was well-tolerated and safe at all doses assessed. It showed favorable pharmacokinetics for further drug advancement. Remi Barbier, the CEO and President of Pain Therapeutics, expressed that the clinical report is promising. Provided the absence of dose-limiting effects in healthy subjects, a remarkable non-clinical safety database, a robust scientific rationale, and numerous research grant awards and peer-reviewed publications, they are eager to move this drug plan to the next level of advancement.
In the Phase 1 study, PTI-125 was assessed in 24 healthy subjects in a single-site in the United States for tolerability, pharmacokinetics and safety. Study subjects were given a single oral dose of 100, 200 or 50 mg of PTI-125. The medication was well-tolerated in all registered volunteers. Importantly, PTI-125 demonstrated no dose-limiting safety findings and no treatment-related adverse effects.
Pharmacokinetic measurements demonstrated PTI-125, a small molecule, was fast absorbed. Dose-proportionality results were seen over the entire dose range. Firm scientists intend to showcase full results of this trial at the 10th Yearly International Conference on CTAD, in Boston, MA. Pain Therapeutics performed this trial with support from a research grant award worth $1.7 million from the National Institute on Aging.
Alzheimer’s disease is a kind of progressive brain disorder that gradually destroys thinking skills and memory, and then the ability to do the simplest tasks. Damage to the brain begins a decade or more before difficulties appear. During this early stage of Alzheimer’s disease, people appear to be symptom-free, however toxic changes are happening in the brain. Ultimately, brain damage becomes extensive and affected people mostly fail to care for themselves.
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