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Psychedelics and cannabis-focused pharmaceutical company PharmaDrug Inc. (CSE:PHRX) (OTCQB:LMLLF) has completed a head-to-head potency comparator study of its two undisclosed DMT-analogue candidates for the treatment of primary open angle glaucoma.
What Happened?
Following this successful outcome, the company, in collaboration with the Terasaki Institute for Biomedical Innovation, has initiated fabrication activities necessary to produce a novel medical device capable of delivering sustained, low (sub-psychedelic) quantities of their undisclosed tryptamine-based pharmaceutical to the front of the eye.
The company intends to use the current results in combination with several planned upcoming in vitro studies to elect its final development candidate.
Future in vivo efficacy testing in an accepted model of POAG is currently being planned with the goal of providing all necessary support to file an investigative new drug application with the FDA to conduct clinical studies.
"Despite the availability of several approved medications, irreversible vision loss related to elevated intraocular pressure remains a significant risk for patients suffering from glaucoma,” Paul Van Slyke, CSO of PharmaDrug, commented. “We are excited to announce that our recently generated data demonstrates that the concept of using select DMT-analogues to activate protective pathways within critical cellular compartments of the eye may provide significant utility in treating elevated IOP."
What’s Next?
The aim of PharmaDrug's DMT-analogue research program in ocular health is to develop suitable prototype medical devices capable of sustained ocular drug-delivery while also confirming efficacy, biocompatibility and stability of its candidate molecules in models of elevated IOP.
The research program scope includes full establishment and demonstration of candidate molecule loading capacity as well as release rate evaluations of conjugated materials using appropriate models that will be used to support an IND application with the FDA in the future.
“The next few months will be vital in further characterizing relative drug potency, selecting a single lead candidate to take forward and fabricating a novel medical device capable of delivering constant and sustained levels of drug to the anterior portion of the eye,” Van Slyke explained. “The following research phase will focus on IND enabling efficacy studies using a well accepted animal model of POAG."
Photo: Courtesy of Marina Vitale on Unsplash