LYS006 / Novartis - LARVOL DELTA

Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=248 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Hidradenitis Suppurativa • Immunology

Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=245 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial primary completion date: Oct 2026 ➔ Nov 2024

Trial primary completion date • Dermatology • Hidradenitis Suppurativa • Immunology

LTA4H inhibitor LYS006: Clinical PK/PD and safety in a randomized phase I clinical trial. (PubMed, Clin Transl Sci) - "LYS006 was well-tolerated and demonstrated a favorable safety profile up to highest doses tested, without any dose-limiting toxicity. This supported further clinical development in phase II studies in predominantly neutrophil-driven inflammatory conditions, such as hidradenitis suppurativa, inflammatory acne, and ulcerative colitis."

Journal • P1 data • PK/PD data • Acne Vulgaris • Dermatology • Gastroenterology • Gastrointestinal Disorder • Hidradenitis Suppurativa • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • LTA4H

Discovery of Amino Alcohols as Highly Potent, Selective, and Orally Efficacious Inhibitors of Leukotriene A4 Hydrolase. (PubMed, J Med Chem) - "The discovery of chiral amino alcohols derived from our previously disclosed clinical LTA4H inhibitor LYS006 is described...Furthermore, compound (S)-2 showed favorable profiles in 16-week IND-enabling toxicology studies in dogs and rats. Based on allometric scaling and potency in whole blood, compound (S)-2 has the potential for a low oral efficacious dose administered once daily."

Journal

Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: May 2023 ➔ Jul 2026 | Trial primary completion date: May 2023 ➔ Jul 2026

Trial completion date • Trial primary completion date • Dermatology • Hidradenitis Suppurativa

Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis (clinicaltrials.gov) - P2 | N=23 | Terminated | Sponsor: Novartis Pharmaceuticals | Completed ➔ Terminated; Sponsor decision due to strategic considerations

Trial termination • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Aug 2023 ➔ May 2023 | Trial primary completion date: Aug 2023 ➔ May 2023

Trial completion date • Trial primary completion date • Dermatology • Hidradenitis Suppurativa

Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis (clinicaltrials.gov) - P2 | N=23 | Completed | Sponsor: Novartis Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis (clinicaltrials.gov) - P2 | N=23 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting | N=45 ➔ 23

Enrollment change • Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Human Pharmacokinetics of LYS006, an Oral Leukotriene A4 Hydrolase Inhibitor Displaying Target-Mediated Drug Disposition. (PubMed, Drug Metab Dispos) - "Significance Statement Pharmacokinetic data from a first-in-human study combined with in vitro work support dose and regimen selection for patient studies with LYS006 and provide guidance on drug interaction investigations and other clinical pharmacology work needed for further development. Mass balance information at steady state without the use of a radiolabel, skin concentrations, identification of the major clearance pathway, as well as the transporters driving elimination, make this a particularly conclusive early study despite nonlinear pharmacokinetics impacted by target binding."

Journal • PK/PD data • Metabolic Disorders

Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial primary completion date: Aug 2022 ➔ Jun 2023

Trial primary completion date • Dermatology • Hidradenitis Suppurativa

Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis (clinicaltrials.gov) - P2 | N=45 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: May 2024 ➔ Nov 2022 | Trial primary completion date: May 2024 ➔ Nov 2022

Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

NEXSCOT: Study of Various Treatments in Non-alcoholic Fatty Liver Disease (NAFLD) Patients Who Have Aspects of Non-alcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - P2 | N=41 | Terminated | Sponsor: Novartis Pharmaceuticals | N=250 ➔ 41 | Trial completion date: Jul 2022 ➔ Jan 2022 | Recruiting ➔ Terminated | Trial primary completion date: Jul 2022 ➔ Jan 2022; Sponsor Decision

Biomarker • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Hepatology • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis

Study to Assess the Efficacy and Safety of LYS006 in Patients With Moderate to Severe Inflammatory Acne (clinicaltrials.gov) - P2 | N=67 | Completed | Sponsor: Novartis Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Acne Vulgaris

Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis (clinicaltrials.gov) - P2 | N=45 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Aug 2023 ➔ May 2024 | Trial primary completion date: Aug 2023 ➔ May 2024

Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Study to Assess the Efficacy and Safety of LYS006 in Patients With Moderate to Severe Inflammatory Acne (clinicaltrials.gov) - P2; N=67; Active, not recruiting; Sponsor: Novartis Pharmaceuticals; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Acne Vulgaris

Study to Assess the Efficacy and Safety of LYS006 in Patients With Moderate to Severe Inflammatory Acne (clinicaltrials.gov) - P2; N=56; Recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: Jun 2022 ➔ Mar 2022; Trial primary completion date: Jun 2022 ➔ Feb 2022

Clinical • Trial completion date • Trial primary completion date • Acne Vulgaris

Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P2; N=200; Recruiting; Sponsor: Novartis Pharmaceuticals; N=130 ➔ 200

Clinical • Enrollment change • Dermatology • Hidradenitis Suppurativa

Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P2; N=130; Recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: Jul 2022 ➔ Jun 2023; Trial primary completion date: May 2022 ➔ Aug 2022

Clinical • Trial completion date • Trial primary completion date • Dermatology • Hidradenitis Suppurativa

NEXSCOT: Study of Various Treatments in Non-alcoholic Fatty Liver Disease (NAFLD) Patients Who Have Aspects of Non-alcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - P2; N=250; Recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: May 2025 ➔ Jul 2022; Trial primary completion date: May 2025 ➔ Jul 2022

Biomarker • Clinical • Trial completion date • Trial primary completion date • Hepatology • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • MRI

Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P2; N=130; Recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: Dec 2022 ➔ Jul 2022; Trial primary completion date: Sep 2022 ➔ May 2022

Clinical • Trial completion date • Trial primary completion date • Dermatology • Hidradenitis Suppurativa

Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis (clinicaltrials.gov) - P2; N=45; Recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: Mar 2023 ➔ Aug 2023; Trial primary completion date: Mar 2023 ➔ Aug 2023

Clinical • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

NEXSCOT: Study of Various Treatments in Non-alcoholic Fatty Liver Disease (NAFLD) Patients Who Have Aspects of Non-alcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - P2; N=250; Recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: Jun 2024 ➔ May 2025; Trial primary completion date: Jun 2024 ➔ May 2025

Biomarker • Clinical • Trial completion date • Trial primary completion date • Hepatology • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis

Study to Assess the Efficacy and Safety of LYS006 in Patients With Moderate to Severe Inflammatory Acne (clinicaltrials.gov) - P2; N=56; Recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: Jul 2021 ➔ Apr 2022; Trial primary completion date: Jul 2021 ➔ Mar 2022

Clinical • Trial completion date • Trial primary completion date • Acne Vulgaris

Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis (clinicaltrials.gov) - P2; N=45; Recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: Jan 2022 ➔ Mar 2023; Trial primary completion date: Jan 2022 ➔ Mar 2023

Clinical • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis