The randomised, double-blind, placebo-controlled, single- and multiple-ascending dose, plus food effects and bridging pharmacokinetics (PK), trial will assess the safety, tolerability, PK, and pharmacodynamics of ABX-002 in these participants.
On concluding the multiple-ascending segment of the trial, the company intends to commence an open-label Phase Ib patient cohort to evaluate the safety and potential impact of the therapy in MDD patients.
These patients have had an insufficient response to an antidepressant.
An oral, selective brain-boosting thyroid receptor beta (TRβ) agonist, ABX-002 had shown target engagement in areas of the brain linked to depression.
A therapeutic dosage of ABX-002 was found to cut down peripheral issues versus the synthetic thyroid hormone, T3.
Similar to the thyroid hormone, this therapy is anticipated to enhance antidepressant treatments by heightening the helpful effects of these drugs on the brain’s monoaminergic signalling.
Autobahn Therapeutics president and CEO Kevin Finney said: “We are thrilled to announce the initiation of our first clinical study with ABX-002, marking an important milestone for Autobahn and the millions of patients living with depression around the world.
“There is a wealth of published literature highlighting the effective use of thyroid hormone in treating depression.
“These historical data, coupled with our preclinical data demonstrating the potent and selective ability of ABX-002 to engage depression-relevant target tissues in the brain, are highly encouraging.”
In September this year, the company raised funds worth $32.7m to back the progress of ABX-002 for treatment-resistant depression.
Existing shareholders of the company ARCH Venture Partners, Cowen Healthcare Investments, BVF Partners, Biogen, Bristol Myers Squibb, and Pfizer Ventures, among others, took part in the financing round.