Avenue Therapeutics Completes the Acquisition of Baergic Bio and its Selective GABA-A α2/3 Receptor Positive Allosteric Modulator for the Treatment of Central Nervous System Disorders

NEW YORK, Nov. 08, 2022 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of central nervous system (“CNS”) diseases, today announced the closing of the acquisition of Baergic Bio, Inc. (“Baergic Bio”) pursuant to the previously disclosed Share Contribution Agreement with its parent company, Fortress Biotech, Inc.

Founded in December 2019, Baergic Bio, now a subsidiary of Avenue, is a clinical-stage pharmaceutical company that focuses on the development of a pharmaceutical product for the treatment of CNS disorders. Its pipeline currently includes a single compound, BAER-101, an oral small molecule selective GABA-A α2/3 receptor positive allosteric modulator, which was in-licensed from AstraZeneca Plc.

The potential therapeutic value of selective modulators of GABA-A receptors has recently been recognized, with multiple assets moving forward since the 2019 U.S. Food and Drug Administration approval of brexanolone. These compounds are being developed for a host of therapeutic indications including epilepsy, anxiety, pain, depression and other related conditions. Preclinical data have substantiated the efficacy of BAER-101 as a novel anxiolytic and antiepileptic.

Benzodiazepines interact non-selectively with GABA-A receptor (GABA-AR) subunits, especially the α1 subunit. By selectively targeting the α2/3 subunits of the GABA-A receptor, BAER-101 may spare the adverse effects associated with benzodiazepine use. Consistent with its selectivity over α1-preferring GABA-ARs, BAER-101 may have a reduced propensity to produce sedation and memory impairment. To date, clinical experience in over 700 patients has shown that BAER-101 is safe and side effects were mild to moderate.

Alexandra MacLean, M.D., Chief Executive Officer of Avenue, said, “The acquisition of Baergic Bio is a step forward in our plan to build Avenue into a leader in the development of drugs targeting unmet needs in the CNS field. BAER-101 has the potential to address various orphan indications as well as larger markets with a favorable profile relative to current therapeutic options. Combined with our recent capital raise and potential regulatory path forward for IV tramadol, we believe Avenue has the foundational portfolio to continue to deliver and expand meaningful therapies for patients with CNS diseases.”

About Avenue Therapeutics
Avenue Therapeutics, Inc. (Nasdaq: ATXI) is a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of central nervous system diseases. Avenue is headquartered in New York City and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.avenuetx.com.  

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Contact:
Jaclyn Jaffe
Avenue Therapeutics, Inc.
(781) 652-4500
ir@avenuetx.com

Released November 8, 2022