Drug Development

In a setback, Regeneron reports a mid-stage flop for next-gen Eylea combo

Regeneron has run into a rare clinical setback. The big biotech reports that one of its next-gen Eylea combos flopped in a Phase II study, falling short on the primary as well as secondary endpoints. And analysts quickly started to assess the potential implications for a rival combo now in Phase III at Ophthotech.

R&D Chief George Yancopoulos

R&D Chief George Yancopoulos

Regeneron added the anti-PDGF antibody rinucumab to its blockbuster drug for age-related macular degeneration. After 12 weeks of therapy the patients in the combo group demonstrated a 5.8-letter improvement in a commonly used eye test. But that compared poorly against the 7.5-letter improvement for Eylea alone.

That’s not all. Adding rinucumab to Eylea “showed no benefit on anatomic endpoints including reduction in retinal thickness or in resolution of subretinal hyper-reflective material,” Regeneron reports. “Ocular adverse events at 12 weeks were more common in the combination treatment groups (23.5 and 20 percent) compared to aflibercept alone (16 percent), primarily driven by an increase in conjunctival hemorrhage, eye irritation and eye pain.”

Jefferies’ Biren Amon says the mid-stage failure may cast a cloud over Ophthotech $OPHT, which is deep into a Phase III adding Fovista (another anti-PDGF) to Lucentis. Its shares dropped 12% in pre-market trading.

There will be more readouts after 28 and 52 weeks, but Regeneron didn’t sound optimistic. It’s changing its focus on a next-gen combo approach to include an anti-angiopoietin 2 antibody.

CSO George D. Yancopoulos had this to say in a statement:

“The addition of rinucumab did not improve on the efficacy of aflibercept alone. We are committed to continuing to innovate for patients with serious vision-threatening diseases, and look forward to the results of our ongoing combination studies of aflibercept and nesvacumab, an anti-angiopoietin 2 antibody, for which the preclinical data is more supportive.”

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Sr. Manager, Regulatory Affairs, CMC
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