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Avenue Therapeutics announced the completion of the last patient visit in its Phase 1b/2a clinical trial of AJ201, aimed at treating spinal and bulbar muscular atrophy (SBMA), also known as Kennedy's Disease.
The company anticipates reporting topline results by mid-2024. The 12-week, multicenter, randomized, double-blind trial included 25 patients, focusing on assessing the safety and tolerability of AJ201, with secondary endpoints examining pharmacokinetic and pharmacodynamic data.
CEO Alexandra MacLean expressed gratitude to all stakeholders involved and highlighted the drug's promising preclinical efficacy and safety profile. The trial is critical, as there are currently no approved treatments for SBMA.
Further study details are available on ClinicalTrials.gov under the identifier NCT05517603.
Avenue Therapeutics (Nasdaq: ATXI) reported its first-quarter 2024 financial results and recent corporate highlights. The company raised $9.4 million in gross proceeds from warrant exercises since January 2024 and increased its cash position to $3.2 million by March 31, 2024. Avenue has made significant progress with its lead clinical program AJ201 for spinal and bulbar muscular atrophy (SBMA) and presented promising preclinical data for BAER-101 in epilepsy treatment. The company plans to initiate a Phase 2a trial for BAER-101 pending necessary financing. Additionally, Avenue reached an agreement with the FDA on the Phase 3 study design for IV tramadol. Research and development expenses rose to $2.4 million, and general and administrative expenses increased to $1.3 million for the first quarter of 2024. Net loss narrowed to $4.3 million from $7.5 million in the same period last year.
Avenue Therapeutics, Inc. (Nasdaq: ATXI) announced the immediate exercise of outstanding warrants for $4.4 million in gross proceeds. The warrants were issued with varying exercise prices and will result in the purchase of 689,680 shares of common stock at a reduced price of $6.20 per share. The proceeds are expected to be used for general corporate purposes, and the transaction is set to close on or about May 1, 2024.
