Highland pulls in $25M for night-dosed morning ADHD treatment

Highland Therapeutics, a Toronto-based company with delayed-release technology for ADHD treatment, brought in $25 million to push its lead candidates through mid- and late-stage trials and prepare for commercialization.

Highland's technology, called Delexis, is a delivery platform for the stimulants methylphenidate and amphetamine with a delayed onset intended to be dosed at night and take effect in the morning. The company says this helps manage ADHD symptoms in the morning after a patient, often a child, has been without his or her normal regimen overnight. The oral, controlled-release technology peaks in the early morning and lasts throughout the day, according to Highland.

The Canadian company's two lead candidates are HLD-200, delivering methylphenidate, and HLD-100, delivering amphetamine. HLD-200 is the furthest along, as the company presented successful Phase II data earlier this month and began a Phase III trial in April. A Phase II study of HLD-100 was also completed this year.

Highland CEO David Lickrish

"I am delighted by the strong show of support evidenced by this financing, which recognizes the progress made by Highland in its evolution to becoming an international pharmaceutical company with a proprietary drug delivery technology and two late-stage products in development," CEO David Lickrish said in a statement. "Looking forward, we anticipate reaching a number of critical near-term milestones, including Phase III data for HLD-200."

The investor this time around went unnamed by Highland. Back in August last year, the company pulled in $6.7 million via its clinical development group to get this far in the trials process.

The control of ADHD symptoms in a delayed-release manner is a particular focus in treating the disorder as companies like Pfizer ($PFE), Neos Therapeutics, Noven Pharmaceuticals and others tailor their delivery options with once-daily, extended-release and even patch options in the pipeline.

- here's the financing release (PDF)
- and this month's earlier data announcement (PDF)

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