lirentelimab subcutaneous (AK002 SC) / Allakos - LARVOL DELTA

MAVERICK: A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria (clinicaltrials.gov) - P2 | N=127 | Terminated | Sponsor: Allakos Inc. | Active, not recruiting ➔ Terminated; No longer pursuing development

Trial termination • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

ATLAS: A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis (clinicaltrials.gov) - P2 | N=131 | Terminated | Sponsor: Allakos Inc. | Active, not recruiting ➔ Terminated; No longer pursuing development

Trial termination • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Allakos Announces Phase 2 Lirentelimab Trials in Atopic Dermatitis and Chronic Spontaneous Urticaria Did Not Meet Their Primary Endpoints (BioSpace) - P2 | N=130 | ATLAS (NCT05155085) | P2b | N=127 | MAVERICK (NCT05528861) | Sponsor: Allakos Inc. | "Allakos, Inc...today announced topline data from its phase 2 clinical trial in patients with atopic dermatitis (ATLAS) and from its Phase 2b clinical trial in patients with chronic spontaneous urticaria (MAVERICK)....Consistent with previously reported antibody-dependent cellular cytotoxicity (ADCC) activity of lirentelimab on eosinophils, patients treated with lirentelimab showed sustained depletion of blood eosinophil counts. In the ATLAS trial, lirentelimab-treated patients’ blood eosinophils decreased by 96% versus placebo-treated patients’ blood eosinophils which decreased by 15%. In the MAVERICK trial, lirentelimab-treated patients’ blood eosinophils decreased by 95% versus placebo-treated patients’ blood eosinophils which increased by 9%."

P2 data • P2b data • Atopic Dermatitis • Chronic Spontaneous Urticaria • Immunology

MAVERICK: A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria (clinicaltrials.gov) - P2 | N=127 | Active, not recruiting | Sponsor: Allakos Inc. | Trial completion date: Dec 2023 ➔ May 2024

Trial completion date • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

ATLAS: A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis (clinicaltrials.gov) - P2 | N=130 | Active, not recruiting | Sponsor: Allakos Inc. | Trial completion date: Dec 2023 ➔ May 2024

Trial completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

MAVERICK: A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria (clinicaltrials.gov) - P2 | N=127 | Active, not recruiting | Sponsor: Allakos Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

ATLAS: A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis (clinicaltrials.gov) - P2 | N=130 | Active, not recruiting | Sponsor: Allakos Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Allakos Provides Business Update and Reports Second Quarter 2023 Financial Results (BioSpace) - "Topline data expected from the Phase 2 study of subcutaneous lirentelimab in patients with atopic dermatitis in late Q4 2023 to Q1 2024. Topline data expected from the Phase 2b study of subcutaneous lirentelimab in patients with CSU in late Q4 2023 to Q1 2024. Following the single and multiple ascending dose portions of the Phase 1 AK006 study in healthy volunteers, initiation of the randomized, double-blind, placebo-controlled cohort in patients with CSU is expected in Q2 2024."

New P1 trial • P2 data • P2b data • Atopic Dermatitis • Chronic Spontaneous Urticaria • Dermatology • Immunology • Inflammation • Urticaria

Phase 2 Trial in Progress— Lirentelimab in Adults with Moderate-to-Severe Atopic Dermatitis Inadequately Controlled by Topical Treatments (RAD 2023) - P2 | "The results of these studies provide a strong rationale for conducting this phase 2 proof-of-concept, randomized, double-blind, placebo-controlled study of lirentelimab SC in adults with moderate–severe atopic dermatitis inadequately controlled by topical treatments (NCT05155085, "ATLAS"). KEY INCLUSION/CRITERIA: Adults (18-80 years) are eligible for screening if they have had chronic AD presented for ≥3 years with moderate-to-severe symptoms defined as: Eczema Area and Severity Index (EASI) score ≥16, involvement of ≥10% of the Body Surface Area (BSA), and Investigator Global Assessment (IGA) score ≥3, documented recent history of inadequate response to treatment with medications such as topical corticosteroids, calcineurin inhibitors, JAK inhibitors, or PDE4 inhibitors (crisaborole), and biologic-naïve or biologic-exposed (secondary loss of response, intolerance, or lack of access)...STUDY SITES: This study is currently enrolling in the USA and..."

Clinical • P2 data • Allergy • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • SIGLEC8

Allakos Provides Business Update and Reports First Quarter 2023 Financial Results (Yahoo News) - "Report topline data from the Phase 2 study of subcutaneous lirentelimab in patients with atopic dermatitis in the second half of 2023. Report topline data from the Phase 2b study of subcutaneous lirentelimab in patients with chronic spontaneous urticaria in the second half of 2023."

P2 data • P2b data • Atopic Dermatitis • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

ATLAS: A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis (clinicaltrials.gov) - P2 | N=130 | Recruiting | Sponsor: Allakos Inc. | Trial completion date: Mar 2023 ➔ Dec 2023 | Trial primary completion date: Mar 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

MAVERICK: A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria (clinicaltrials.gov) - P2 | N=110 | Recruiting | Sponsor: Allakos Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

MAVERICK: A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria (clinicaltrials.gov) - P2 | N=110 | Not yet recruiting | Sponsor: Allakos, Inc.

New P2 trial • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

ATLAS: A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis (clinicaltrials.gov) - P2 | N=130 | Recruiting | Sponsor: Allakos, Inc. | N=240 ➔ 130

Enrollment change • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

ATLAS: A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Allakos, Inc. | Initiation date: Dec 2021 ➔ May 2022

Trial initiation date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Allakos Announces Expansion of Lirentelimab Development into Atopic Dermatitis, Chronic Spontaneous Urticaria and Asthma (GlobeNewswire) - "Phase 2 Asthma trial of subcutaneous lirentelimab to begin in Q4 2022....Allakos...today announced it has initiated a randomized, double-blind, placebo-controlled Phase 2 clinical trial of subcutaneous (SC) lirentelimab in adult patients with moderate-to-severe atopic dermatitis..."

Trial status • Asthma • Atopic Dermatitis • Immunology • Respiratory Diseases

ATLAS: A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis (clinicaltrials.gov) - P2; N=240; Recruiting; Sponsor: Allakos, Inc.

Clinical • New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Evaluate Safety, Tolerability, and Bioavailability of Subcutaneous Lirentelimab (AK002) in Adult Healthy Volunteers (clinicaltrials.gov) - P1; N=66; Completed; Sponsor: Allakos, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion

A Study to Evaluate Safety, Tolerability, and Bioavailability of Subcutaneous Lirentelimab (AK002) in Adult Healthy Volunteers (clinicaltrials.gov) - P1; N=58; Active, not recruiting; Sponsor: Allakos, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed