- Adverum Biotechnologies Inc ADVM has decided to drop the development of ADVM-022 intravitreal (IVT) injection gene therapy in diabetic macular edema (DME) after dose-limiting toxicity (DLT) was observed at the high dose (6 x 10^11 vg/eye) in patients with DME.
- In April, Adverum's stock plunged after a Suspected Unexpected Serious Adverse Reaction of decreased ocular pressure was reported in one patient in the high-dose cohort of the INFINITY Phase 2 trial.
- After that disclosure, it immediately unmasked the trial and monitored all patients who received a single high dose of ADVM-022.
- Additional patients treated with a single high dose of ADVM-022 experienced decreased intraocular pressure refractory to steroids and required subsequent additional treatment.
- These events occurred 16-36 weeks after treatment with the high dose. No similar events have been observed in DME patients treated with the low dose or to date in any wet age-related macular degeneration (wet AMD) patients.
- Now, the company is planning to evaluate ADVM-022 at low doses (2 x 10^11 vg/eye and lower) and alternative prophylactic regimens in future Phase 2 trial in wet AMD.
- It plans to present long-term OPTIC data in wet AMD in 2H21, including 52-week data from Cohort 4 (high dose of 6 x 10^11 vg/eye with steroid eye drop prophylaxis, n=9), at a medical conference.
- Analyst Reaction: SVB Leerink lowered the price target from $5 to $2 but maintained a Market Perform rating.
- Price Action: ADVM Shares are down 21.6% at $2.40 during the premarket session on the last check Friday.
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