FDA Clears Autobahn's IND for Phase 2 Trial of ABX-002 in Bipolar Depression

Autobahn Therapeutics, a biotech company focused on developing restorative treatments for neuropsychiatric and neuroimmunologic disorders, announced the clearance of an investigational new drug (IND) application by the U.S. FDA. This clearance supports the initiation of a Phase 2 trial of ABX-002 as an adjunctive treatment for patients with bipolar depression. ABX-002 is a highly potent, oral, thyroid hormone beta receptor (TRβ) selective agonist designed to enhance the CNS benefits of thyroid hormone biology and drug concentrations directly in the brain.

Publish Date: 22-10-2024 Source: Autobahn Therapeutics

Bipolar depression is frequently misdiagnosed as unipolar depression due to the overlap in clinical symptoms between these two conditions. Patients may not recognize their ‘high’ periods as illness, leading them to seek assistance only during depressive episodes. As a result, bipolar depression often goes unrecognized for several years, especially in cases of bipolar II disorder, where hypomania episodes can be mistaken for a return to normal mood after depression. In over 50% of bipolar disorder cases, depression is the initial manifestation of the illness, creating a diagnostic challenge in distinguishing it from unipolar depression. The symptom profile includes psychomotor retardation, ‘atypical’ features such as increased appetite and excessive sleep (reverse neurovegetative), and sometimes psychotic symptoms. Episodes of bipolar depression tend to be more rapid in onset, more frequent, and shorter in duration than unipolar depression. However, in practice, there is often a mix of manic and depressive symptoms, making it challenging to differentiate unipolar and bipolar depression, particularly in the absence of obvious prior manic episodes. Clinical management is thus influenced by diagnostic uncertainty. Managing bipolar depression is further complicated by underdiagnosis, especially in the early stages when treatment response is most effective. Underdiagnosis and misdiagnosis result in inadequate and inappropriate treatment for bipolar depression. The most suitable treatment approaches approved by the US Food and Drug Administration (FDA) include the olanzapine–fluoxetine combination (OFC) and quetiapine.

However, the current Bipolar Depression treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (Abilify®, Lumateperone (ITI-007), Esketamine, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Bipolar Depression treatment. The key companies in the advanced development stage are Otsuka Pharmaceutical, Intra-Cellular Therapies, Inc., Celon Pharma SA, etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Bipolar Depression to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2023 to 2033.

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