Annexon: Positive Phase 1 Results For ANX1502; ANX007 Registrational Program; Prices $125 Mln Shares

Annexon Inc. (ANNX), a clinical-stage biopharmaceutical company focused on inflammatory-related diseases, reported Wednesday positive results from the Phase 1 trial of ANX1502, its oral small molecule inhibitor of the classical complement pathway.

On Nasdaq, Annexon shares gained 1.8 percent on regular trading, and 7.6 percent further in the after hours activity.

Separately, the company outlined its global registrational program for ANX007, a first-in-class C1q and classical complement inhibitor, for the treatment of patients with geographic atrophy or GA.

Annexon also announced the pricing of an underwritten public offering of 25.04 million common shares at $2.88 per share, and pre-funded warrants to purchase 18.38 million shares at a price of $2.879 per share. The total gross proceeds to Annexon are expected to be around $125 million. The offering is expected to close on December 26, subject to the satisfaction of customary closing conditions.

Regarding the Phase 1 trial of ANX1502, the company noted that the results were from single ascending dose or SAD and multiple ascending dose or MAD healthy volunteer study.

ANX1502 is a first-in-kind oral, selective small molecule inhibitor that targets the active form of C1s responsible for propagating classical pathway activation in association with C1q.

The completed Phase 1 clinical trial is a randomized, double-blind, placebo-controlled SAD and MAD study to assess the safety, tolerability, pharmacokinetic or PK and pharmacodynamics or PD of ANX1502 liquid suspension formulation in healthy adults.

The study evaluated single ascending doses of ANX1502 ranging from 25 mg to 1050 mg and multiple ascending doses of ANX1502 ranging from 200 mg twice-daily to 525 mg twice-daily.

The company noted that target levels of active drug were achieved in healthy volunteers with oral twice-daily dosing. ANX1502 generally was well tolerated across cohorts with no serious adverse events.

The tablet formulation of ANX1502 is expected to advance into proof-of-concept study in patients with cold agglutinin disease or CAD in 2024

Regarding ANX007, the company noted that registration program will initiate first with ARCHER II, a global sham-controlled trial designed to confirm the results from the Phase 2 ARCHER trial, and potentially expedite the path to regulatory approval in Europe.

Annexon plans to conduct its injection-controlled head-to-head study, ARROW, against SYFOVRE (pegcetacoplan injection), with the potential to underscore ANX007’s unique mechanism of action and critical differentiation on visual function. ARCHER II is expected to begin enrollment in mid-2024, followed by ARROW in late 2024.

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