vibozilimod (SCD-044) / Sun Pharma, Sun Pharma Advanced Research Company, Bioprojet - LARVOL DELTA

SOLARES-AD-1: To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=250 | Completed | Sponsor: Sun Pharmaceutical Industries Limited | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

SOLARES-AD-1: To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=238 | Active, not recruiting | Sponsor: Sun Pharmaceutical Industries Limited | Trial completion date: Jun 2025 ➔ Mar 2025

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

SOLARES-PsO-1: To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=263 | Active, not recruiting | Sponsor: Sun Pharmaceutical Industries Limited | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2024 ➔ Apr 2025 | Trial primary completion date: Aug 2024 ➔ Nov 2024

Enrollment closed • Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

Sphingosine-1-Phosphate Receptor 1 (S1P1) Agonist, Vibozilimod (BS6.890C), Effect on Bradycardia, Preclinical to First-in-human Clinical Translation (EADV 2024) - "Vibozilimod (VBZ, BS6.890C) is a novel S1PR agonist that acts on S1P1R and S1P5R while antagonizing S1P4R with significant lack of activity towards S1P3R...Materials & VBZ, etrasimod, ozanimod and siponimod were administered intravenously at a dose of 3 mg/kg in anesthetized male Sprague-Dawley rats and their effects on heart rate (HR) and mean arterial blood pressure (MAP) were studied... VBZ, a differentiated agonist at S1P1 and S1P5 receptors produced only a transient and well manageable effect on heart rate in humans, with faster recovery as observed in the preclinical model. Thus, the effects of VBZ observed in animal studies were successfully translated in humans in terms of reduction in magnitude of heart rate in Phase I study, thus providing improved safety on cardiac function."

P1 data • Preclinical • Anesthesia • Cardiovascular • Immunology • Inflammation • Macular Edema • Ophthalmology • S1PR1

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Vibozilimod: A Randomized, Double-blind, First-in-human, Study in Healthy Male and Female Subjects (EADV 2024) - "Vibozilimod was well-tolerated with only mild to moderate adverse events (AEs) up to a dose of 6 mg. Transient bradycardia, a known class effect, was observed with a mean heart rate reduction of less than 10 beats/min up to a dose of 0.3 mg. Bradycardia effects plateaued at doses of 2 mg and above."

Clinical • P1 data • PK/PD data • Alopecia • Atopic Dermatitis • Cardiovascular • CNS Disorders • Dermatitis • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Lupus • Multiple Sclerosis • Psoriasis

SOLARES-AD-1: To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=238 | Active, not recruiting | Sponsor: Sun Pharmaceutical Industries Limited | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

SOLARES-PsO-1: To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Sun Pharmaceutical Industries Limited | Trial completion date: Apr 2024 ➔ Nov 2024 | Trial primary completion date: Feb 2024 ➔ Aug 2024

Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Sun Pharmaceutical Industries Limited | Trial completion date: Dec 2023 ➔ Jun 2025 | Trial primary completion date: Sep 2023 ➔ Jan 2025

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

To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Sun Pharmaceutical Industries Limited | Trial completion date: May 2023 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Sep 2023

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

To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Sun Pharmaceutical Industries Limited | Trial completion date: Dec 2022 ➔ Apr 2024 | Trial primary completion date: Apr 2022 ➔ Feb 2024

Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=240; Recruiting; Sponsor: Sun Pharmaceutical Industries Limited; Not yet recruiting ➔ Recruiting

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

To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2; N=240; Recruiting; Sponsor: Sun Pharmaceutical Industries Limited; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Dermatology • Immunology • Psoriasis

Sun Pharma initiates Phase 2 clinical trial of SCD-044 (Business Standard) - "SCD-044 is also being evaluated...and Phase 2 studies for other indications like atopic dermatitis, are also expected to be initiated soon....In May-2020, Sun Pharma entered into a worldwide in-licensing agreement with Sun Pharma Advanced Research Company (SPARC) for the development and commercialization of SCD-044, which is being evaluated as a potential oral treatment for psoriasis, atopic dermatitis and other auto-immune disorders."

Licensing / partnership • New P2 trial • Atopic Dermatitis

Sun Pharma commences Phase 2 clinical trial for psoriasis drug (Yahoo Finance) - "Sun Pharma on Monday said it has initiated Phase 2 clinical trial for a product being developed to treat patients with moderate to severe plaque psoriasis...The study will enrol around 240 subjects and topline results are expected in 2022, it added."

P2 data • Trial status • Immunology • Psoriasis

To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=240; Not yet recruiting; Sponsor: Sun Pharmaceutical Industries Limited

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

To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2; N=240; Not yet recruiting; Sponsor: Sun Pharmaceutical Industries Limited

Clinical • New P2 trial • Dermatology • Immunology • Psoriasis