Manufacturing, CRO’s and IP

Manufacturing

Instead of trying to harvest DMT from natural sources, a process which can result in issues with purity and supply, synthetically produced DMT will provide a source of stable and trusted drug substance and will enable the supply of large quantities for all Algernon research purposes as well as clinical needs going forward, on a global scale.

Algernon is currently engaged in discussions with a Health Canada and U.S. FDA approved drug manufacturing company that has the experience and required licensure for the manufacturing and handling of DMT.

CRO's

Algernon has retained CRO Clinical Development Solutions (“CDS”), to support all aspects of the investigational brochure, study protocol and Pre-IND and IND application with the U.S. FDA as well as the CTA with Health Canada. CDS will provide high-level oversight and management of all clinical trials.

The Company has also retained Novotech to conduct a feasibility study for Algernon to conduct all or part of its DMT stroke clinical research program in Australia. The Company has currently engaged Novotech for its Phase 2 clinical study for idiopathic pulmonary fibrosis and chronic cough as well as COVID-19. Australia is a favoured country for clinical research because of its government supported 43.5% refundable tax credit program.

Algernon is also exploring conducting its DMT clinical research program in other countries as well.

Intellectual Property

Algernon has filed new provisional patents for new forms of DMT, in addition to formulation, dosage and method of use claims for ischemic stroke. The Company has also filed claims for combination therapy of DMT and CIMT.

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