Carthera’s SONOBIRD Pivotal Trial Reaches First Milestone

Carthera has enrolled the first 100 patients in its SONOBIRD pivotal trial for recurrent glioblastoma treatment. A spin-off of Sorbonne University founded by neurosurgeon Prof. Alexandre Carpentier, Carthera reached this milestone as it prepares to conduct the largest clinical trial ever using ultrasound for temporarily opening the blood-brain-barrier (BBB) in recurrent glioblastoma patients.

Nearly all 40 participating sites across Europe and the Unied States are now active. Carthera expects recruitment will continue to swiftly reach the 560-patient study total. “It has been a privilege to offer this trial to patients with recurrent glioblastoma. The underlying concept is highly promising, device implantation has proceeded smoothly and patients have shown strong interest in participating,” said Dr. Brian Gill, assistant professor of neurosurgery at Columbia University Irving Medical Center in New York, N.Y.

The trial is the world’s first randomized, multicentric, two-arm pivotal study of BBB opening prior to chemotherapy injection in recurrent glioblastoma patients. Notably, the trial makes use of the SonoCloud, an ultrasound-based medical device developed by Carthera to treat a wide range of brain disorders. Specifically, the trial compares the use of SonoCloud combined with carboplatin versus standard therapies in patients with a first recurrence of glioblastoma.

“We desperately need new treatments for patients with recurrent glioblastoma. SonoCloud has the potential to transform our ability to deliver a high dose of therapeutics to the brain,” stated Dr. Marjolein Geurts, a neuro‐oncologist at Erasmus Medical Center Cancer Institute in Rotterdam, the Netherlands.

To date, more than 550 SonoCloud treatments have been performed worldwide, confirming Carthera’s position in ultrasound-based BBB opening, as well as the growing interest in SonoCloud as a potentially viable new treatment option for recurrent glioblastoma patients.

“Our progress in recruiting patients reflects the engagement and strong support from our clinical sites, and from the neuro-oncology and surgery community, in advancing innovative therapies,” Carthera Chief Clinical Officer Carole Desseaux stated. “We are very grateful for the commitment and enthusiasm of the patients and clinicians who are taking part in this trial.”

Initiated in February 2024, the registrational study aims to enroll 560 U.S. and EU patients within two years, with a view to obtaining marketing authorization. The first interim analysis of the clinical data will be available soon.

“Achieving this milestone is an important step in introducing our SonoCloud device to the large patient population urgently in need of solutions to improve treatment outcomes,” Carthera CEO Frederic Sottilini said. “With its breakthrough device and orphan drug designations, Carthera remains committed to transforming glioblastoma treatment and to acquiring market access for its technology.”

The open-label, comparative, randomized, multicenter, two-arm clinical trial with a one-to-one ratio aims to evaluate overall survival in patients undergoing carboplatin chemotherapy and treated with the SonoCloud system to open the BBB. This is compared to the medical consensus recommended regimens (lomustine or temozolomide). The trial also evaluates the effectiveness of the SonoCloud and carboplatin treatment in delaying or slowing tumor growth.

The SONOBIRD trial follows on from the SC9-GBM-01 trial, which demonstrated the feasibility and the safety profile of SonoCloud, as well as the potential of carboplatin tested as a monotherapy in combination with BBB opening.

SonoCloud emits ultrasound to temporarily increase blood vessel permeability in the brain to improve the delivery of therapeutic molecules. Invented by Prof. Alexandre Carpentier and developed in collaboration with the Laboratory of Therapeutic Applications of Ultrasound (Laboratoire Thérapie et Applications Ultrasonores, LabTAU, INSERM) in Lyon, France, SonoCloud is implanted into the skull and activated prior to injection of a therapeutic agent. Several minutes of low-intensity ultrasound opens the blood-brain barrier for six hours and increases the concentration of therapeutic molecules in the brain. This ultrasound-induced BBB opening is considered a world-first, offering a new treatment option for a wide range of indications, including brain tumors and Alzheimer’s disease.

SonoCloud is an investigational product, the device has not yet received EMA or U.S. Food and Drug Administration (FDA) approval.

Carthera is a clinical-stage medtech company developing ultrasound-based medical devices to treat a wide range of brain disorders. The company is a spin-off from AP-HP Paris and Sorbonne University. Carthera leverages the inventions of Carpentier, head neurosurgeon at AP-HP Sorbonne university, who has achieved worldwide recognition for his developments in treating brain disorders. SonoCloud, an intracranial implant that temporarily opens the blood-brain barrier, is currently in clinical trials in Europe and the United States. It received FDA Breakthrough Device Designation in 2022, and FDA/EMA Orphan Drug Designation in 2023 for carboplatin when used with SonoCloud.

Founded in 2010 by Carpentier, run by Sottilini, and chaired by Oern Stuge, M.D., Carthera has offices in France (Lyon and Paris) and a subsidiary in Boston. Since its inception, the technical and clinical development of SonoCloud has received support from the National Research Agency (ANR), the French public investment bank (Bpifrance), the National Institutes of Health (NIH), and the European Innovation Council (EIC).