A Dose-Response Safety Study of ENX-102 in Patients With GAD

• ENX-102 (Drug), also known as ENX-102 low-dose, ENX-102 mid-dose, ENX-102 high-dose: Four weeks of ENX-102 (0.5, 1, or 3 mg) in capsule form followed by 2 weeks of tapered dose, taken orally once daily in the evening for a 6-week total treatment period
• Placebo (Drug): Six weeks of placebo in capsule form taken orally once daily in the evening for a 6-week total treatment period

Primary outcomes

• Safety and tolerability [4 weeks]: • Incidence and severity of treatment-emergent AEs (TEAEs)

Sex: All, ages: 18 Years to 65 Years

Key Inclusion Criteria:

* Male or female, inclusive of any gender identity, aged 18 to 65 years, inclusive
* Diagnosed with GAD according to the DSM-V, confirmed by MINI
* Experiencing clinically significant generalized anxiety as measured by HAM-A score ≥18 and at least moderately severe core symptoms of anxious mood and tension as measured by HAM-A Items 1 and 2, respectively, with scores each ≥2

Key Exclusion Criteria:

* Clinically predominant psychiatric diagnosis other than GAD per the MINI
* Any past/lifetime or current diagnosis of a neurocognitive disorder or psychotic disorder, or current posttraumatic stress disorder, obsessive compulsive disorder, or bipolar disorder
* Ingested prohibited medication within 5 half-lives prior to Day 1
* Current or recent moderate or severe substance use disorder as assessed by the MINI
* Unwilling or unable to abstain from alcohol or other recreational psychoactive substances such as marijuana during participation in the trial
* Has significant progressive disorders or unstable medical conditions
* Is unable to comply with the requirements of the study or, in the opinion of the Investigator, is unsuitable for the study

• Kimberly Vanover, PhD, Study director, Engrail Therapeutics INC