Biotech Values

[DewDiligence]

(REGN)—NVS’ wet-AMD drug, RTH258 hits primary endpoint in phase-2 trial:

http://www.novartis.com/newsroom/media-releases/en/2015/1898139.shtml

The Phase II study met its primary endpoint, demonstrating promising visual acuity gains that were non-inferior to aflibercept [Eylea], with numerically greater reduction and rapid improvement in abnormal retinal fluid observed in RTH258-treated patients.

Patients treated every three months with RTH258 also experienced a prolonged duration-of-action, potentially leading to a reduced treatment burden.

A total of 90 patients diagnosed with wet AMD participated in the prospective, randomized, double-masked multicenter, two-arm study. The primary objective was to compare the efficacy of RTH258 6mg versus aflibercept 2mg with the primary endpoint being the mean change in best corrected visual acuity (BCVA), from Baseline to Week 12. Secondary endpoints included the change assessment in BCVA and central subfield foveal thickness (CSFT) as measured by spectral domain optical coherence tomography (SD-OCT). Both RTH258 and aflibercept were well tolerated and no new safety signal was reported during the study.

Deatiled data (not in the above PR) were presented at the annual meeting of The Macula Society today. That the phase-2 trial was successful was already known insofar as NVS in Jan 2015 started a 1,700-patient (upsized from 1,000) phase-3 trial of RTH258 vs Eylea (#msg-110292779).

RTH258 is NVS’ next-generation anti-VEGF compound that may eventually be co-formulated with OPHT’s Fovista.