ABX-002 / Autobahn Therap - LARVOL DELTA

Study of ABX-002 for the Adjunctive Treatment of Depressive Episodes Associated With Bipolar Depression in Adults (clinicaltrials.gov) - P2 | N=35 | Recruiting | Sponsor: Autobahn Therapeutics, Inc.

New P2 trial • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Psychiatry

Autobahn Therapeutics Announces Initiation of Phase 2 Trial of ABX-002 as an Adjunctive Treatment for Bipolar Depression (Businesswire) - P2 | N=230 | AMPLIFY (NCT06633016) | Sponsor: Autobahn Therapeutics, Inc | "Autobahn Therapeutics...announced the initiation of a Phase 2 clinical trial evaluating ABX-002, its highly potent, oral, thyroid hormone beta receptor (TRβ) selective agonist, as an adjunctive treatment in adults with bipolar depression...The Phase 2 open-label trial will study ABX-002 as an adjunctive treatment in 30 adult patients with depressive episodes associated with bipolar I and bipolar II disorder and will utilize neuroimaging assessments and validated clinical scales to evaluate changes in metabolites associated with brain energy metabolism and improvements in depressive symptoms...ABX-002 is also being evaluated in the company’s ongoing AMPLIFY Phase 2 trial as an adjunctive treatment for patients with major depressive disorder (MDD), with topline data expected in the second half of 2025."

P2 data • Trial status • Bipolar Disorder • Major Depressive Disorder

Autobahn Therapeutics Announces FDA Clearance of IND Application for ABX-002 as an Adjunctive Treatment for Bipolar Depression (Businesswire) - "Company to initiate Phase 2 trial of ABX-002 for bipolar depression by yearend 2024...Autobahn Therapeutics...announced the clearance of an investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA) to support initiation of a Phase 2 trial of ABX-002 as an adjunctive treatment for patients with bipolar depression....ABX-002 is also being evaluated in the company’s ongoing AMPLIFY Phase 2 trial as an adjunctive treatment for patients with major depressive disorder (MDD), with topline data expected in the second half of 2025."

IND • New P2 trial • P2 data • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder

Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder (AMPLIFY) (clinicaltrials.gov) - P2 | N=230 | Recruiting | Sponsor: Autobahn Therapeutics, Inc.

New P2 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • CRP

Autobahn Therapeutics Completes Oversubscribed $100 Million Series C Financing to Advance Pipeline of Novel Therapeutics for Depression and Other CNS Disorders (Businesswire) - "Autobahn Therapeutics...announced the closing of an oversubscribed $100 million Series C financing led by Newpath Partners, with participation from new investors Canaan Partners, Monograph Capital, and Insight Partners....Proceeds from the Series C will be used to commence two Phase 2 clinical trials for the company’s lead program, ABX-002...In the second half of 2024, Autobahn plans to initiate Phase 2 trials designed to provide biological and clinical proof-of-concept of ABX-002 as an adjunctive treatment for patients with major depressive disorder (MDD) and patients with bipolar disorder depression....With the proceeds from this raise, Autobahn will also advance ABX-101, a next-generation, brain-penetrant, oral sphingosine 1-phosphate (S1P) receptor modulator for the treatment of neuroimmunologic and neuroinflammatory disorders, into Phase 1 clinical testing."

Financing • New P2 trial • CNS Disorders • Depression • Major Depressive Disorder

SAD/MAD of ABX-002-1902 Investigating the Safety, Pharmacokinetics/Pharmacodynamics of in Healthy Subjects (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Autobahn Therapeutics, Inc. | Not yet recruiting ➔ Completed | N=104 ➔ 48

Enrollment change • Trial completion

Autobahn Therapeutics Completes Dosing in its Phase 1 Multiple-ascending Dose Study of ABX-002 for Major Depressive Disorder and Reports Company Progress (Businesswire) - "Autobahn has completed dosing in its double-blind, randomized, placebo-controlled, single- and multiple ascending dose and food effect Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of its lead candidate, ABX-002, in healthy volunteers....The company plans to assess and report topline data from the Phase 1 study in the fourth quarter of 2023. Based on the Phase 1 experience, Autobahn plans to submit an investigational new drug (IND) application to the US. Food and Drug Administration and advance into a Phase 2 clinical trial in their target patient population of patients with major depressive disorder (MDD) in the first half of 2024."

Enrollment closed • IND • P1 data • CNS Disorders • Major Depressive Disorder

Autobahn Therapeutics Advances ABX-002, its Lead Oral Treatment for Major Depressive Disorder, into Multi-Ascending Dose Portion of Phase 1 Trial (Businesswire) - "Autobahn Therapeutics...announced that it has initiated the multiple ascending dose (MAD) portion of its Phase 1 study of ABX-002 in healthy subjects. Autobahn is evaluating ABX-002, a potent and selective thyroid receptor beta (TRβ)-selective agonist, as a potential adjunctive treatment for people with major depressive disorder (MDD)....Following completion of the multiple-ascending portion of the study, Autobahn plans to initiate an open label, Phase 1b patient cohort, as part of this study, to explore the safety and activity of ABX-002 in patients diagnosed with MDD who have had an inadequate response to their antidepressant."

Trial status • CNS Disorders • Depression • Immunology • Major Depressive Disorder

Robust hippocampal and cortical target engagement induced by ABX-002, a novel thyromimetic in development for major depressive disorder (MDD) (Neuroscience 2022) - "Both regions represent areas key to known pathophysiology in depression. Thus, ABX-002 is a novel approach to treatment of TRD."

CNS Disorders • Depression • Major Depressive Disorder • Mental Retardation • Mood Disorders • Psychiatry

Abx-002, a novel thyroid receptor beta-selective agonist, demonstrates functional brain delivery in vivo and enhances efficacy in an eae model in combination with immune-modifying therapy (Neuroscience 2022) - "Histological analysis of spinal cord 28 days after immunization demonstrated a reduction of inflammatory foci, apoptotic cell count, and area of demyelination with ABX-002 or FTY720 dosed alone and an even larger decrease when in combination. Analysis of gene expression in the brains of these animals demonstrated robust induction of thyroid-responsive genes, demonstrating engagement of the TRβ in the CNS.In summary, thyromimetic prodrugs demonstrate enhanced brain delivery in vivo and have efficacy in models of MS, both independently and when used in combination with existing MS therapies."

Combination therapy • Preclinical • CNS Disorders

SAD/MAD of ABX-002-1902 Investigating the Safety, Pharmacokinetics/Pharmacodynamics of in Healthy Subjects (clinicaltrials.gov) - P1 | N=104 | Not yet recruiting | Sponsor: Autobahn Therapeutics, Inc.

New P1 trial