The Toronto-based company said that it will be focusing on comparing the potency of two candidate tryptamines, which were narrowed from an initial list of six
PharmaDrug Inc announced that the Terasaki Institute for Biomedical Innovation (TIBI) will commence in vitro characterization studies on PharmaDrug's short-list of N, N-dimethyltryptamine (DMT) analogue molecules, which will support IND-enabling studies for the US Food and Drugs Administration (FDA) review.
The psychedelic research company said that it has commissioned TIBI, under a research agreement, to develop a novel ocular drug delivery platform that aims to deliver psychedelic and tryptamine-based pharmaceuticals, related to DMT for eye diseases.
"We are extremely excited to finalize the first stage of the program in devising an initial list and selecting a final set of two candidate DMT analogue molecules. Initial in vitro efficacy studies will commence immediately, said Daniel Cohen, CEO of PharmaDrug.
He added: The next few months will be vital in characterizing relative drug potency and selecting a single lead candidate to take forward for further development. The following phase will focus on IND enabling efficacy studies using a well-accepted animal model of POAG (primary open-angle glaucoma)."
The Toronto-based company said that it will be focusing on comparing the potency of two candidate tryptamines, which were narrowed from an initial list of six. Current studies at TIBI will take place in three phases in vitro, head-to-head evaluation of potency in cell-based models of glaucoma;evaluation of efficacy (ability to lower intraocular pressure - IOP) when applied as a topical eyedrop in animal models of glaucoma; and development and testing of a medical device capable of delivering sustained, local, sub-psychotropic levels of the development candidate to patients afflicted with glaucoma.
PharmaDrug said that it is anticipating an update on initial research results in late November.
Glaucoma is a disorder of the optic nerve that results in irreversible vision loss and is the second leading cause of blindness in the world, according to the World Health Organization.
Glaucoma impacts more than 2.7 million people aged 40 or older in the USand current treatments are known to have poor rates of compliance of up to 80% of patients. The global market for glaucoma was estimated by Market Scope at $4.8 billion in 2019 with the US market representing $1.9 billion.
Tryptamines are thought to work differently to lower IOP and as such, potentially embody a new class of glaucoma medications that may be used alone, or in combination with already approved medications.
The substance, often hallucinogenic above certain threshold concentrations, constitutes a large collection of molecules that selectively act on multiple different serotonin receptors including 5-HT1A and 5-HT2A. Topical application of several different tryptamines has shown early promise in preclinical models of elevated IOP.
However, factors such as formulation, delivery, the potential for undesirable hallucinogenic side effects, and the Controlled Substances Act of 1970 have all contributed to a lack of development of tryptamines to treat this serious threat to vision.
PharmaDrugs streamlined focus on two highly promising, undisclosed tryptamines as a potential therapeutic solution in treating glaucoma represents a potential paradigm shift, the statement said.
The pharmaceutical company is focused on the research, development, and commercialization of controlled substances and natural medicines such as psychedelics, cannabis, and naturally-derived approved drugs.
Contact Ritika at ritika@proactiveinvestors.com
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