Regeneron gains on new long-term Phase 2 data for Eylea in wet AMD
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Regeneron (REGN
+3.6%) has recorded the biggest intraday gain in more than three months after reporting 44-week data from a Phase 2 trial for the companyâs blockbuster therapy Eylea (aflibercept) at 8 mg dose in wet age-related macular degeneration (wet AMD).
Announcing 16-week data last August, Regeneron (NASDAQ:REGN) said that the proof-of-concept trial involving 106 patients for aflibercept met its primary safety endpoint compared to the currently approved 2 mg dose of Eylea.
At week 44, the group who received the aflibercept 8 mg indicated a 7.9 average letter improvement from baseline, while those who received the 2 mg dose had a 5.1 average improvement based on the Early Treatment Diabetic Retinopathy Study (ETDRS) letters (nominal p=0.1957).
47% in the 8 mg group achieved at least a 10-letter gain, and 28% achieved more than 15 letters compared to 35% and 18% in the 2 mg group for the therapy.
40% (n=21/53) of patients in aflibercept 8 mg group did not develop fluid in the center subfield vs. 28% (n=15/53) in 2 mg Eylea group (nominal p=0.2185).
In H2 2022, the company expects data from a Phase 3 trial which could indicate the long-term therapeutic effect of aflibercept 8 mg, Chief Scientific Officer at Regeneron (REGN) George D. Yancopoulos remarked.
The late-stage data âwill show that aflibercept 8 mg can deliver clinical outcomes that, at a minimum, will be comparable to standard-of-care EYLEA, but allow for extended dosing regimens," he noted.
After the results, H.C. Wainwright reiterated the Overweight rating on Regeneron (REGN), noting that the âreassuringâ data âturns up the heatâ in a rivalry with Rocheâs (OTCQX:RHHBY) recently approved eye disease therapy, Vabysmo for patients with wet AMD and diabetic macular edema.