Carthera has enrolled the first patient in a pivotal trial evaluating its low-intensity pulsed ultrasound (LIPUS)-based technology which helps drugs reach the brain in higher concentrations.

The French medtech company is initially testing its SonoCloud device in patients receiving chemotherapy for glioblastoma, the most common type of brain cancer.

The SONOBIRD study (NCT05902169) aims to treat 560 patients with recurrent glioblastoma across 40 sites in Europe and the US.

Carthera’s SonoCloud-9 device will be used in combination with carboplatin, a chemotherapy drug. Despite its approval for glioblastoma treatment, the drug does not readily cross the blood-brain-barrier – a semi-permeable membrane between the blood and brain tissue. Carthera says the technology temporarily opens the barrier, allowing more carboplatin to reach brain tumour tissue.

The trial’s primary endpoint is overall survival measured after two years. Secondary outcome measures include progression-free survival, tumour growth rate, and overall survival at earlier follow-ups.

Patients receiving Carthera’s paradigm will be compared to those who receive the chemotherapy drugs lomustine and temozolomide – the current standard of care.

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By GlobalData

Professor Johnny Duerinck, who enrolled the first two patients in the study, said: “By utilising Carthera’s SonoCloud-9 device to temporarily open the BBB in the areas surrounding the tumour, we will be able to assess the effectiveness of carboplatin against existing treatments, with the aim of providing glioblastoma patients with better therapeutic options.”

The pivotal trial follows the company’s Phase I/IIa SC9-GBM-01 trial. Carthera says whilst the full results will be unveiled in Q2 2024, early results demonstrated the feasibility and the safety profile of SonoCloud-9.

Carthera, a spin-off from AP-HP Paris and Sorbonne University, developed its SonoCloud platform to address a wide range of brain disorders. The technology was granted the US Food and Drug Administration (FDA) breakthrough device designation in 2022.

Administered as an implant in a skull window, the device is activated by a transdermal needle connection to an external control unit. The device temporarily disrupts the blood-brain barrier, with repeats possible for each cycle of a drug therapy.

“Other companies are trying to get ultrasound through the skull using focused ultrasound. A major drawback is that the ultrasound has to cross the skull, with 95% of the energy reflected or diffracted. You need to use MRI monitoring, and that means the procedure can be very long – taking three to four hours,” Carthera CEO Frédéric Sottilini told sister site Medical Device Network in June 2023.

“A major advantage of our technology is that it can be activated on demand, it only takes two to four minutes for us to open the blood-brain-barrier at a large volume encompassing the tumour and the surrounding tissue.”

In June 2023, the company bagged €37.5m ($40.2m) to fund its trial activities, which also include indications in brain metastases and Alzheimer’s disease. The Series B was backed by European Innovation Council Fund amongst others.