Pharma

Once-weekly drug for Parkinson’s disease symptoms could reach clinical trials in 2013

A drug for Parkinson’s disease that could ease some of the complications associated with current dopamine replacement therapies could reach clinical trials next year. Serina Therapeutics’ platform technology is based on the polymer polyoxazoline (POZ), which the company is pairing with rotigotine (a dopamine agonist also used UCB’s FDA-approved Neupro patch) to create a once-weekly […]

A drug for Parkinson’s disease that could ease some of the complications associated with current dopamine replacement therapies could reach clinical trials next year.

Serina Therapeutics’ platform technology is based on the polymer polyoxazoline (POZ), which the company is pairing with rotigotine (a dopamine agonist also used UCB’s FDA-approved Neupro patch) to create a once-weekly injected drug to address the motor-function symptoms of Parkinson’s disease. The company recently completed an $11 million fund-raise, according to an SEC filing turned in this month.

Researchers today understand Parkinson’s to occur from the destruction of cells in various parts of the brain, including the substantia nigra, where dopamine is produced. Without dopamine, the brain doesn’t properly transmit signals that allow for coordinated movement.

There’s no cure for Parkinson’s disease; current treatment regimens focus on managing the most disruptive motor symptoms. They often include drugs that convert into dopamine in the brain, mimic the effects of dopamine or block the breakdown of dopamine in the brain. These treatments, Serina says, are limited because they intermittently deliver dopamine, leading to spikes and drops in dopamine levels that can contribute to changes in motor function. The company’s drug candidate, SER-214, is designed to provide continuous dopaminergic stimulation (CDS) for up to one week.

“Such therapy would likely be associated with a decreased incidence of motor complications such as dyskinesias, as well as better patient compliance,” the company says on its website. “It may also be useful as an adjunctive therapy in patients with established motor fluctuations.”

Recent regulatory filings show that Serina has raised at least $15 million in capital since its founding. Company officials did not respond to a request for more information, but according to Serina’s website, they are working on IND-enabling studies with plans to begin a Phase I clinical trial in late 2013.

There are more than 150 drugs in the Parkinson’s disease pipeline – a majority of them in the preclinical stage. Preladenant, a non-dopamine treatment developed by Schering-Plough, is in Phase 3 trials now, as are drugs from Abbott and Acadia Pharmaceuticals.

In addition to SER0214, which is also being advanced to treat other disorders like restless leg syndrome, Serina is working on an oncology drug that targets the alpha-folate receptor, which is thought to be over-expressed in some human solid tumors.

The Huntsville, Alabama, company was founded and is managed by former executives of Shearwater/Nektar Therapeutics. It’s located at the HudsonAlpha Institute for Biotechnology.