STOP-HAE: A Phase 3 Study of ADX-324 in HAE

Key Inclusion Criteria:

• Age ≥18 years at the time of signing informed consent.

• Have a documented diagnosis of HAE-1/HAE-2 (Type I or II)

• Experience ≥1 Investigator-confirmed HAE attack in the first 4 weeks of Screening or ≥2 Investigator-confirmed HAE attacks in 8 weeks of Screening

• Able to use at least one acute therapy to treat HAE attacks (such as aplasma-derived or recombinant C1-INH concentrate or a BK2-receptor antagonist)

Key Exclusion Criteria:

• Concurrent diagnosis of another form of recurrent angioedema (such as acquiredangioedema, HAE with normal C1-INH (previously known as HAE Type III), idiopathicangioedema, or recurrent angioedema associated with urticaria).

• Any clinically significant renal disease

• Any clinically significant hepatic disease

• Have used any of the following for long-term prevention of HAE attacks:

1. C1-INH agent (CINRYZE, HAEGARDA, RUCONEST) within 2 weeks prior to Screening.

2. Berotralstat (ORLADEYO) within 3 weeks prior to Screening.

3. Lanadelumab (TAKHZYRO) within 8 weeks prior to the Screening.

4. Androgen use within 12 weeks prior to Screening.

• Received prior treatment with any RNA/DNA-based therapy for HAE or intolerant to anyprior RNA/DNA-based therapy for any condition, excluding vaccines.