Dive Brief:
- France-based biotechnology company Sensorion is discontinuing development of a gene therapy for a rare form of deafness after Regeneron Pharmaceuticals won approval for a rival product and agreed to offer it for free in the U.S.
- Researchers have been testing Sensorion’s treatment, called SENS-501, in a Phase 1/2 study of patients with mutations in a gene known as OTOF. Yet, the approval of Regeneron’s Otarmeni in April “notably changed the development environment,” Sensorion said Wednesday. Regeneron will offer Otarmeni at no cost as part of a larger drug pricing deal with the U.S. government.
- Following a strategic review, Sensorion has chosen to instead focus on starting human trials of “SENS-601,” a different experimental medicine designed to treat a more common form of deafness linked to mutations in the GJB2 gene. “Concentrating Sensorion’s resources on SENS-601, where the unmet need is an order of magnitude larger and no approved therapy is currently available, is the right strategic decision,” the company said.
Dive Insight:
While the move sets back the timeline for Sensorion to bring a product to market, it makes sense in the long run, according to analysts. Without the expenses of continuing the “Audiogene” trial of SENS-501, the biotech’s cash reserves should last until the end of 2027.
“For a company of Sensorion’s size, careful resource allocation is critical,” Stifel analyst Clemence Thiers wrote in a note to clients. Regeneron’s introduction of Otarmeni and the decision to offer it at no cost “would likely have made the U.S. market near impossible to access for a follow-on product.”
The work done to advance SENS-501 won’t go to waste. Lili Nsongo, an analyst at Leerink Partners, argues that Sensorion gained valuable experience with trial development and regulatory issues that will likely “result in greater clinical development efficiency” for SENS-601.
The pivot to SENS-601 is a “sensible move,” Nsongo wrote in her own client note.
Sensorion has been working with a French research team led by the renowned geneticist Christine Petit to develop SENS-601, a gene therapy that employs adeno-associated viruses. The treatment has prompted “significant hearing restoration” in animal models, Petit said in the company’s statement.
“The scientific and clinical advances of Audiogene are directly guiding and increasing our confidence in SENS-601,” she added.
Sensorion shares, which trade on the Euronext Paris stock exchange, fell roughly 25% between Wednesday and Thursday.
