Annexon finds more silver linings in failed eye disease trial ahead of talks with FDA

Annexon finds more silver linings in failed eye disease trial ahead of talks with FDA

Annexon has found more to love in its failed phase 2 eye disease clinical trial. Months after framing the study as a success in its top-line results, the biotech has returned with further analyses that it pitched as evidence ANX007 is a promising, differentiated geographic atrophy candidate.

In May, Annexon took the positives from its flunked phase 2 clinical trial, looking past the failure to meet the primary endpoint and focusing on the effect on visual function. The biotech shared some data on the vision test to make its case. Monday, Annexon returned with more data that, in its view, support the case that ANX007 provides consistent protection from vision loss and justify further development.

The biotech used an oral presentation at the American Society of Retina Specialists’ 2023 annual meeting to share some of the new evidence. At the event, Annexon explained that the effect on vision loss held up in a more conservative analysis and was consistent across different subgroups of patients.

Ahead of an investor call to share more data, the biotech teased some of the findings in a press release. The additional analyses show that patients in the ANX007 arm lost vision at the same rate as people in the placebo arm once they stopped taking the medicine. Gains made during treatment persisted, but the rate of vision deterioration picked up again.

In a statement, Annexon CEO Douglas Love said the results show “robust, dose and time dependent preservation of vision loss in the broad patient population.” The priority is to advance the drug candidate “as efficiently as possible,” Love said, and meetings with regulators to decide “the optimal path forward” are planned for later this year.

It appears that not all investors share Annexon’s level of enthusiasm for the data. While the biotech’s share price ticked up 6.3% to $3.41 in premarket trading Monday after the release of the new analyses, the stock remains well down on the price it commanded before news of the phase 2 trial failure broke. Annexon ended March with $228.2 million in cash and equivalents, a sum it forecast would fund operations into 2025.

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