Engrail Therapeutics has initiated the Phase II ENCALM clinical trial of ENX-102 for the treatment of patients with generalised anxiety disorder (GAD).

The multi-centre, placebo-controlled, randomised, double-blind study intends to assess the safety and efficacy of ENX-102 alone in GAD patients.

Male or female patients aged 18 to 65 years diagnosed with GAD are administered with a 2mg ENX-102 capsule for four weeks.

They are then followed for three weeks, including a tapered dose week and two weeks of a placebo in capsule form given once daily in the evening, for a nine-week total treatment period.

The placebo group is dosed once daily in the evening for six weeks out of a nine-week period.

Engrail Therapeutics chief scientific officer Kimberly Vanover said: “Translational and Phase I clinical data indicate central target engagement, with a highly differentiated safety and tolerability profile for ENX-102 against non-selective GABA-A positive allosteric modulators (PAMs) such as benzodiazepines.

“ENX-102 exhibits a long half-life and can be dosed once daily, without titration. These data support further evaluation of ENX-102 for efficacy in generalised anxiety disorder.”

ENX-102 is an investigational, subtype-selective, gamma-aminobutyric acid A (GABA-A) PAM that enhances the neurotransmission of GABA in α2, α3, and α5 receptors while blocking α1.

Engrail CEO and president Vikram Sudarsan said: “The initiation of Phase II and further advancement of the rest of our precision neuroscience pipeline makes 2023 a hallmark year for the organisation.”

The company is also engaged in developing transformational therapies that improve the lives of patients with neurodevelopmental, neuropsychiatric, and neurologic disorders.