The discontinuation of the uveitis study adds to Regeneron’s series of clinical setbacks, including the Phase 3 failures of the Dupixent follow-up itepekimab and an investigational combo regimen for melanoma.
Regeneron has terminated a Phase 1/2 study of an investigational anti-inflammatory antibody, which was being tested for non-infectious uveitis.
The decision to end the trial is due to an “unfavorable benefit-risk assessment” of the candidate, called REGN7041, according to a federal clinical trials database. BioSpace has reached out to Regeneron for more details regarding the discontinuation of the study and the company’s future plans for REGN7041. The asset is no longer listed on the pharma’s pipeline page.
REGN7041 is a monoclonal antibody that targets CD3, a marker found on immune cells that drives the inflammatory cascade. Non-infectious uveitis is an eye disease characterized by inflammation of a layer of the eye. Common symptoms include redness, pain, sensitivity to light and compromised eyesight. There hasn’t yet been an anti-CD3 therapy approved for uveitis.
The discontinuation of the uveitis study continues somewhat of a losing streak for Regeneron. In May last year, for instance, the pharma announced that itepekimab—an interleukin-33 blocker that many had been eyeing as a follow-up to Dupixent—failed one of two late-stage chronic obstructive pulmonary disease trials. A year later, the pharma’s investigational melanoma combo kneeled to Merck’s Keytruda in a Phase 3 trial.
In the face of these setbacks, analysts have been piling on the M&A pressure as a way for Regeneron not just to beef up its pipeline, but also make use of what BMO Capital Markets last month called the pharma’s “financial strength.”
The company, for its part, has clarified that it is not “allergic to any external opportunity,” CEO Leonard Schleifer said during a second quarter investor call in July. “We look at them all, but we are pretty disciplined in trying to create value with these transactions.”
While it’s true that Regeneron hasn’t signed a mega-deal in a while, the pharma has indeed been looking externally for innovation. Just in the past few months, the pharma has inked a handful of partnerships, including one with Telix in April, putting up to $4.3 billion on the line to advance radiopharmaceutical programs for several cancer indications.
Shortly after, Regeneron linked up with Parabilis Medicines in a deal that could potentially reach $2.3 billion, hoping to unlock a new class of medicines called antibody-helicon conjugates to address previously undruggable targets.
