PharmaDrug Inc announced that it has successfully completed a head-to-head potency comparator study of its two undisclosed DMT-analogue candidates for the treatment of primary open-angle glaucoma (POAG).
Following this successful outcome, the company, in collaboration with the Terasaki Institute for Biomedical Innovation (TIBI), has initiated fabrication activities necessary to produce a novel medical device capable of delivering sustained, sub-psychedelic quantities of their undisclosed tryptamine-based pharmaceutical to the front of the eye.
PharmaDrug said that it 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 (IND) application with the FDA to conduct clinical studies, the company said.
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"Despite the availability of several approved medications, irreversible vision loss related to elevated intraocular pressure (IOP) remains a significant risk for patients suffering from glaucoma,” Paul Van Slyke, chief science officer of PharmaDrug said in a statement. “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.”
He noted that 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 the drug to the anterior portion of the eye.
“The following research phase will focus on IND enabling efficacy studies using a well-accepted animal model of POAG," Slyke said.
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 scope of the research program 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 company has completed its initial potency evaluation of two test articles using an in vitro calcium mobilization assay on trabecular meshwork cells; a cell type known to be critically important in the maintenance of healthy IOP.
Both test articles were found to activate calcium mobilization, to levels that were comparable or greater than the experimental positive control, ionomycin. The company's test articles were previously examined for in vitro toxicity and were found to be non-toxic to trabecular meshwork cells at concentrations expected to be used in treatment for various eye diseases.
Fabrication of a drug-loaded prototype medical device has been initiated and studies, including biocompatibility are underway to evaluate drug release in cell and cell-free model systems.
Collectively the results of these studies will be used to select a lead development candidate that will be taken forward into in vivo efficacy models for eye diseases, including glaucoma.
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