bermekimab sc (MABp1 sc) / J&J - LARVOL DELTA

Interleukin-1α inhibitor bermekimab in patients with atopic dermatitis: randomized and nonrandomized studies. (PubMed, Arch Dermatol Res) - P1, P2, P2a, P2b | "GENESIS (NCT04791319, N = 198) was a double-blind, placebo- and active-comparator-controlled, randomized (1:1:2:2) study of placebo, subcutaneous bermekimab (350 mg or 700 mg qw), or dupilumab. The novel human ex vivo skin pharmacodynamic assay demonstrated that bermekimab reduced downstream skin injury responses. Although bermekimab showed potential as an AD treatment in preclinical and early open-label trials, larger controlled studies (Study 2 and GENESIS) did not confirm those initial results."

Clinical • Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

LYRA: A Study of Bermekimab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=151 | Terminated | Sponsor: Janssen Research & Development, LLC | Phase classification: P2a/2b ➔ P2

Phase classification • Dermatology • Hidradenitis Suppurativa • Immunology

XBIOTECH INC. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-K) (Market Screener) - "During the years ended December 31, 2022 and 2021 net cash (used in) provided by operating activities was $(14.8) million and $69.4 million, respectively. Net cash used in the year ended December 31, 2022 primarily resulted from our net income and losses, whereas for the year ending December 31, 2021 the company received $75 million from escrowed funds from the sale of bermekimab."

Commercial • Immunology • Systemic Sclerosis

A Study of JNJ-77474462 (Bermekimab) in Healthy Chinese Participants (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Janssen Research & Development, LLC | N=36 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal

LYRA: A Study of Bermekimab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P2a/2b | N=151 | Terminated | Sponsor: Janssen Research & Development, LLC | N=300 ➔ 151 | Trial completion date: May 2024 ➔ Oct 2022 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2023 ➔ Oct 2022; Study has been prematurely terminated as the Interim Analysis 1 efficacy results met the prespecified futility criteria related to the primary endpoint.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Dermatology • Hidradenitis Suppurativa

The Benefit of Bermekimab in Patients With Systemic Sclerosis (clinicaltrials.gov) - P2 | N=20 | Completed | Sponsor: Hellenic Institute for the Study of Sepsis | Active, not recruiting ➔ Completed

Trial completion • Fibrosis • Immunology • Scleroderma • Systemic Sclerosis

Safety, Pharmacokinetics, and Efficacy of RA-18C3 in Subjects With Moderate to Severe Psoriasis (clinicaltrials.gov) - P2; N=8; Completed; Sponsor: XBiotech, Inc.; Active, not recruiting ➔ Completed

Clinical • PK/PD data • Trial completion • Dermatology • Immunology • Psoriasis • CRP

LYRA: A Study of Bermekimab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P2a/2b | N=300 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Sep 2023 ➔ Dec 2023

Trial primary completion date • Dermatology • Hidradenitis Suppurativa

GENESIS: A Study of Bermekimab (JNJ-77474462) in the Treatment of Participants With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2b | N=199 | Terminated | Sponsor: Janssen Research & Development, LLC | Trial completion date: Aug 2022 ➔ Mar 2022 | Active, not recruiting ➔ Terminated; Premature Termination due to Interim Analysis (100 patients at Week 16) meeting futility.

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

A Study of JNJ-77474462 (Bermekimab) in Healthy Chinese Participants (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Oct 2022 ➔ Nov 2023 | Initiation date: Mar 2022 ➔ May 2023 | Trial primary completion date: Oct 2022 ➔ Nov 2023

Trial completion date • Trial initiation date • Trial primary completion date

GENESIS: A Study of Bermekimab (JNJ-77474462) in the Treatment of Participants With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2b | N=199 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jun 2022 ➔ Feb 2022

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

A Study of JNJ-77474462 (Bermekimab) in Healthy Chinese Participants (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC

New P1 trial

XBiotech Announces Clinical Manufacturing Agreement [Google traslation] (finanzen.net) - "XBiotech Inc...today announced an agreement with Janssen Research & Development, LLC to manufacture clinical products including bermekimab, a true human monoclonal antibody, which XBiotech sold to Janssen in December 2019....The new agreement extends XBiotech's production support through December 2023."

Licensing / partnership • Atopic Dermatitis • Dermatitis • Dermatology • Hidradenitis Suppurativa • Immunology • Psoriasis

GENESIS: A Study of Bermekimab (JNJ-77474462) in the Treatment of Participants With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2b; N=200; Recruiting; Sponsor: Janssen Research & Development, LLC; Trial primary completion date: Nov 2021 ➔ Jun 2022

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

J&J to record $610 mln charge related to skin disease drug (Reuters) - "Drugmaker Johnson & Johnson...said on Wednesday it would take a non-cash impairment charge of about $610 million in the first quarterover its decision to stop the development of a skin disease treatment. The drug, bermekimab...J&J said it had decided to terminate the development of the drug for atopic dermatitis following the availability of additional efficacy data....J&J said bermekimab will retain a carrying value of about $150 million relating to hidradenitis suppurativa, after the impairment charge."

Discontinued • Atopic Dermatitis • Dermatology • Hidradenitis Suppurativa • Immunology

LYRA: A Study of Bermekimab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P2a/2b; N=290; Recruiting; Sponsor: Janssen Research & Development, LLC; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Dermatology • Hidradenitis Suppurativa

A Study of JNJ-77474462 (Bermekimab) in Healthy Participants of Japanese Descent Following Administration of Single Ascending Subcutaneous Doses (clinicaltrials.gov) - P1; N=24; Completed; Sponsor: Janssen Research & Development, LLC; Active, not recruiting ➔ Completed

Clinical • Trial completion

A Study of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P2a; N=60; Not yet recruiting; Sponsor: Janssen Research & Development, LLC

New P2a trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study of JNJ-77474462 (Bermekimab) in Healthy Participants of Japanese Descent Following Administration of Single Ascending Subcutaneous Doses (clinicaltrials.gov) - P1; N=24; Active, not recruiting; Sponsor: Janssen Research & Development, LLC; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

A Study of JNJ-77474462 in Healthy Participants (clinicaltrials.gov) - P1; N=78; Completed; Sponsor: Janssen Research & Development, LLC; Recruiting ➔ Completed

Clinical • Trial completion

XBiotech Announces Receipt of $75 Million from Sale of Antibody (GlobeNewswire) - "XBiotech (NASDAQ: XBIT) announced today it received $75 million from funds escrowed as part of its December 2019 sale of bermekimab. The True Human™ antibody developed by the company to treat inflammatory disorders, including skin diseases, was sold in a uniquely structured Pharma deal that allowed XBiotech to continue to develop new anti-inflammatory antibodies against the same target. With the receipt of $75 million, XBiotech has now received a total of $750 million pursuant to the deal....According to the purchase agreement, XBiotech can develop these new True Human antibodies for all indications in medicine with the exception of dermatological indications. XBiotech could potentially receive up to $600 million more in cash from the deal by agreeing to provide exclusivity for certain additional indications with bermekimab."

Commercial • Immunology

GENESIS: A Study of Bermekimab (JNJ-77474462) in the Treatment of Participants With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2b; N=200; Recruiting; Sponsor: Janssen Research & Development, LLC; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Safety, Pharmacokinetics, and Efficacy of RA-18C3 in Subjects With Moderate to Severe Psoriasis (clinicaltrials.gov) - P2; N=8; Completed; Sponsor: XBiotech, Inc.; N=10 ➔ 8

Clinical • Enrollment change • PK/PD data • Dermatology • Immunology • Psoriasis • CRP

GENESIS: A Study of Bermekimab (JNJ-77474462) in the Treatment of Participants With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2b; N=200; Not yet recruiting; Sponsor: Janssen Research & Development, LLC

Clinical • New P2b trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Evaluate the Safety and Efficacy of Bermekimab in Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=86; Completed; Sponsor: Janssen Research & Development, LLC; Active, not recruiting ➔ Completed

Clinical • Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology