Katharine Sepp, chief executive officer, and Joost Schulte, chief scientific officer, co-founders of Oxalys Pharma, knew that they had discovered a promising new drug candidate for treating neurodegenerative disorders such as Parkinson’s and Huntington diseases but the challenge was to figure out a way to successfully commercialize their discovery.

While conducting research at MIT, they developed a drug discovery model for neurodegenerative diseases. Their discovery was a drug that protects brain cells from accelerated aging that occurs in disorders such as Huntington and Parkinson’s diseases. The drug they identified protects the brain in two ways. The drug activates cellular quality-control mechanisms that become less efficient with age. It also reduces the stress hormone cortisol, which has a degenerative impact on the brain if chronically high.

They targeted the U.S. Food and Drug Administration’s (FDA) Orphan Drug Designation Program that was designed to provide incentives for new drugs for debilitating rare diseases. The program provides product market exclusivity that can extend beyond the life of its patent, and gives fee exemptions and tax advantages. The program did not require any application fee and had a fast turnaround time for evaluation of the discovery..........

They hope to be in clinical trials in one year, which is many years shorter than normal.

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