ThecaFlex provides access to the cerebrospinal fluid for therapies infusion requiring repeat IT dosing. Credit: Life science / Shutterstock.com.

Alcyone Therapeutics has announced plans to begin a pivotal study of its ThecaFlex DRx System for the administration of SPINRAZA (nusinersen).

The company’s decision comes after it received investigational device exemption approval from the US Food and Drug Administration (FDA) to initiate the trial.

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The PIERRE trial will assess the performance and safety of the subcutaneous port and intrathecal catheter system for cerebrospinal fluid (CSF) aspiration, repeat intrathecal access and SPINRAZA delivery in spinal muscular atrophy (SMA) subjects.

SPINRAZA is a Biogen therapy, which received approval to treat infants, children and adults with SMA.

Alcyone will recruit up to 90 patients for the trial, which will be carried out in two stages.

The company plans to begin the trial’s first stage later this year in a limited number of US sites. It will enrol and implant up to ten patients who will be followed for one month.

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Expected to start next year, the second stage will recruit an additional 80 subjects in several sites across Europe and the US.

Alcyone CEO PJ Anand said: “Alcyone is excited to begin the process of evaluating the safety and performance of ThecaFlex in SMA patients being treated with SPINRAZA.

“ThecaFlex represents the culmination of a deliberate effort to design a delivery system specifically for repeat bolus intrathecal drug delivery.”

Part of the company’s Falcon Delivery Platform, ThecaFlex is an implantable intrathecal catheter, catheter fixation device and subcutaneous port system.

It will provide access to the CSF for therapies infusion requiring repeat IT dosing.

The system is expected to serve as an alternative to lumbar puncture. It is also anticipated to become the first implantable device that can facilitate routine subcutaneous access for the delivery of antisense oligonucleotide therapies.

ThecaFlex already received a CE mark in Europe and a breakthrough device designation from the FDA.