NIH Grant Boosts Delpor’s Plans for Tizanidine Implant

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by Vanda Pinto PhD |

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The development of Delpor‘s DLP-208 implant for the treatment of moderate-to-severe spasticity, a symptom that commonly affects people with multiple sclerosis (MS), has been boosted by a National Institutes of Health (NIH) grant.

The $2.5 million grant will help the company advance DLP-208 into clinical testing, which is expected to happen by 2023.

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If approved by regulatory agencies, DLP-208 will be the first minimally invasive therapy that provides long-term relief for moderate-to-severe spasticity, the company said in a press release.

Spasticity is a common symptom of MS and other conditions such as cerebral palsy, traumatic brain injury, and spinal cord injury. It causes muscle stiffness and painful and severe muscle spams that make movement difficult, ultimately affecting patients’ well-being and overall quality of life.

The two most common medications used for spasticity are baclofen and tizanidine.

Baclofen is a muscle relaxant that acts at the level of motor neurons — the nerve cells responsible for voluntary movement — and reduces their activation. The treatment can be taken orally or delivered directly into-the-spinal canal (intrathecal infusion) for people who cannot tolerate the oral formulations. However, oral regimens require treatment three times a day, and the intrathecal formulation requires an invasive, one-to-three hour surgical procedure with serious risks to patients.

Tizanidine is a short-acting medication that relaxes tightened muscles and prevents pain sensations from being delivered to the brain. It also is available as capsules, under the brand name Zanaflex, but must be taken three times a day.

To overcome these limitations, Delpor developed an implant that is placed in the abdomen and releases steady and therapeutic concentrations of tizanidine into circulation for about 3-6 months. The implant is placed via a minimally invasive, 10-minute, in-office procedure, and prevents adverse side effects from excessively high or low drug concentrations, as can happen with oral formulations.

“Compared to existing spasticity treatment options, the proposed product will substantially improve safety, maintain efficacy during maintenance treatment, and increase overall treatment success,” the grant application said. “The final outcome will be an improvement in patient lives, and a reduction in overall healthcare costs.”

“We’ve created DLP-208, a tizanidine implant which can provide sustained therapy for several months, while only requiring a 10-minute procedure performed in an outpatient setting,” said Tassos Nicolaou, president and CEO of Delpor.

“The product has the potential to enhance treatment outcomes appreciably and confer measurable benefits that improve the quality of life for spasticity patients,” he said.

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