Following convincing results from a recent In-Vitro study, the Danish biotech company, Tetra Pharm Technologies, announces successful In-Vivo study results of its candidate compound, TPT0301.
The In-Vivo study focuses on establishing the pharmacokinetic profile of TPT0301 in fasted rats over the course of 24 hours following gastro-intestinal (GI) administration. The candidate compound was formulated using Tetra Pharm Technologies' proprietary drug delivery technology and compared against a simplistic formulation principle commonly utilized for cannabinoids.
"The In-Vivo tests establish essential pharmacokinetic information, demonstrating significantly faster onset of absorption and high exposure of TPT0301 following GI administration. The combined pre-clinical package, i.e., including the previously announced In-Vitro results confirming high permeation through the mucosa in the mouth, is unique in the sense that it establishes the effectiveness of our drug delivery technology in two types of oral administration: Orally to the GI tract and sublingually, i.e., under the tongue. In the case of the latter, the fraction of dose, inevitably lost to the GI tract, will be absorbed to a high extent. The pre-clinical data therefore confirm the suitability of TPT0301 for sublingual administration while also providing us with the option to consider conventional oral administration", says Dr. Morten Allesø, Chief Scientific Officer, Tetra Pharm Technologies.
The target of TPT0301 is the endocannabinoid system (ECS), which is a widespread neuromodulatory system that regulates and controls various physiological processes to maintain balance and homeostasis within the human body, such as learning and memory, emotional processing, sleep, temperature, pain control, inflammatory and immune responses, and appetite.
"The demonstrated strong preclinical performance of TPT0301 increases our confidence in the upcoming First-in-Human trials. Achieving a robust blood-plasma profile is a key enabler of successful dose-finding", added Dr. Morten Allesø.
Tetra Pharm Technologies is currently planning for First-in-Human trials of TPT0301 to commence in Q4 2023.
"We are very excited about the outcomes of the pre-clinical studies of TPT0301 and look forward to initiating the first phase of clinical studies. Research and development are our top priority, and we will continue to invest in building our pipeline of new drug candidates targeting the endocannabinoid system (ECS) and related disease indications", says Martin Rose, CEO, Tetra Pharm Technologies.
For more information, please visit www.tetrapharm.eu
