Annexon’s ANNX stock declined 51.7% last week after it reported mixed results from a phase II study on its lead pipeline candidate, ANX007, in patients with geographic atrophy (GA), the leading cause of blindness. In the phase II study on ANX007 in patients with GA, the candidate failed to reduce the rate of growth of lesions despite preserving functional vision in such patients compared to sham.
On May 24, the company announced top-line data from the phase II study ARCHER study, which showed that ANX007 preserved visual acuity, achieving statistically significant protection against vision loss in both foveal and non-foveal patients through the 12-month treatment period. The vision loss was measured by changes from baseline in the widely accepted functional endpoint of best corrected visual acuity (BCVA).
The data showed a 72% reduction in the risk of 15-letter loss in patients treated monthly with ANX007 and a 48% reduction in the risk of 15-letter loss in those treated every other month with ANX007. Patients in the pooled treatment group showed a 59% reduction in risk of >15-letter loss.
However, the study failed to reach statistical significance for the primary endpoint of a mean rate of change (slope) in the GA lesion area. In other words, the study did not reach statistical significance for reducing the rate of geographic atrophy lesion growth. In the monthly treatment group, the reduction in lesion growth was 6.2%, while that in the every-other-month treatment group was 1.3%. Meanwhile, a 3.7% reduction was observed in the pooled patient population.
Annexon’s stock has declined 44.9% this year so far compared with a decrease of 9.2% for the industry.
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GA is a vision loss disease caused by the loss of photoreceptor cells, a type of neuron. Annexon claims ANX007 has a distinct neuroprotective mechanism, which is designed to target and preserve photoreceptor cells, synapses and function. Annexon believes the totality of the top-line data is promising and it plans to meet regulatory agencies to decide on the plan for the phase III study on the candidate.
Apellis Pharmaceuticals’ APLS Syfovre (pegcetacoplan injection) is the first and only approved therapy for treating GA secondary to age-related macular degeneration (AMD). Syfovre was approved in February this year. Apellis also submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for intravitreal pegcetacoplan to treat GA. The EMA subsequently provided MAA validation and the application is under review.
IVERIC bio’s ISEE new drug application seeking approval of lead pipeline candidate, avacincaptad pegol for treating GA secondary to AMD is under priority review of the FDA, with a decision expected on Aug 19. In April. IVERIC bio entered into a definitive agreement to be acquired by Japan’s Astellas. Under the agreement, Astellas will acquire 100% of the outstanding shares of Iveric Bio for $40.00 per share in cash for a total equity value of approximately $5.9 billion
Annexon currently has a Zacks Rank #3 (Hold).
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