GED-0507 / Nogra Pharma, Japan Tobacco - LARVOL DELTA

A Study to Assess Efficacy and Safety of N-Acetyl-GED-0507-34-LEVO Gel 5%, in Patients With Acne Vulgaris (GEDACNE-1) (clinicaltrials.gov) - P3 | N=400 | Active, not recruiting | Sponsor: PPM Services S.A. | Recruiting ➔ Active, not recruiting

Enrollment closed • Acne Vulgaris • Dermatology

A Long-term Safety and Efficacy Study of N-Acetyl-GED-0507-34-LEVO Gel 5%, in Subjects With Acne Vulgaris (GEDACNE-LT) (clinicaltrials.gov) - P3 | N=400 | Active, not recruiting | Sponsor: PPM Services S.A. | Recruiting ➔ Active, not recruiting

Enrollment closed • Acne Vulgaris • Dermatology

GEDACNE-2: A Study to Assess Efficacy and Safety of N-Acetyl-GED-0507-34-LEVO Gel 5% in Patients With Acne Vulgaris (GEDACNE 2) (clinicaltrials.gov) - P3 | N=400 | Active, not recruiting | Sponsor: PPM Services S.A. | Recruiting ➔ Active, not recruiting

Enrollment closed • Acne Vulgaris • Dermatology

NACGED0507ACN0123LT: A Clinical Study in which patients with acne vulgaris will receive a new topical drug for long term. The safety and efficacy of the drug will be tested. (clinicaltrialsregister.eu) - P2/3 | N=320 | Active, not recruiting | Sponsor: PPM Services S.A. | Recruiting ➔ Active, not recruiting

Enrollment closed • Acne Vulgaris • Dermatology

NACGED0507ACN0123B: A Clinical Study in which patients with acne vulgaris will receive a new topical drug. The safety and efficacy of the drug will be tested. (clinicaltrialsregister.eu) - P2/3 | N=310 | Active, not recruiting | Sponsor: PPM Services S.A. | Recruiting ➔ Active, not recruiting

Enrollment closed • Acne Vulgaris • Dermatology

GEDACNE-2: A Phase III Study to Assess Efficacy and Safety of N-Acetyl-GED-0507-34-LEVO Gel 5% in Patients With Acne Vulgaris (GEDACNE 2) (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: PPM Services S.A.

New P3 trial • Acne Vulgaris • Dermatology

A Phase III Study to Assess Efficacy and Safety of N-Acetyl-GED-0507-34-LEVO Gel 5%, in Patients With Acne Vulgaris (GEDACNE-1) (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: PPM Services S.A.

New P3 trial • Acne Vulgaris • Dermatology

A Long-term Safety and Efficacy Study of N-Acetyl-GED-0507-34-LEVO Gel 5%, in Subjects With Acne Vulgaris (GEDACNE-LT) (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: PPM Services S.A.

New P3 trial • Acne Vulgaris • Dermatology

Cost-Effectiveness of the PPARγ Modulator N-Acetyl-Ged-0507-34-Levo (NAC-GED 5%) Versus Benzoyl Peroxide-Adapalene for Moderate to Severe Acne (ISPOR-EU 2023) - "Furthermore, NAC-GED 5% demonstrated comparable efficacy to oral isotretinoin (<120 mg/kg) with a similar cost, the shorter onset of action, and lower discontinuation rates. NAC-GED 5% showed favorable results in acne improvement and cost-effectiveness, with lower discontinuation rates and good efficacy."

Cost effectiveness • HEOR • Acne Vulgaris • Dermatology • PPARG

Successful modulation of the PPARγ-receptor in the treatment of Acne Vulgaris: Results of an international phase 2b study with NAC-GED-0507 gel. The GEDACNE Study (WCD 2023) - "The topical application of the PPARγ modulator NAC-GED reduced TLC, increased IGA success rate, and was safe for patients with facial acne vulgaris. Our data confirm the unique ability of NAC-GED to simultaneously target multiple pathogenic factors of acne through an innovative mechanism of action and elicit an effective clinical response"

P2b data • Acne Vulgaris • Dermatology • Pruritus • PPARG

Efficacy and Safety of N-Acetyl-GED-0507-34-LEVO Gel in Patients with Moderate-to Severe Facial Acne Vulgaris: A Phase 2B randomised double-blind, vehicle-controlled trial. (PubMed, Br J Dermatol) - P2 | "The topical application of NAC-GED 5% reduced TLC, increased the IGA success rate and was safe for patients with acne vulgaris. Thus, NAC-GED, a new PPARγ modulator, showed an effective clinical response."

Clinical • Journal • P2b data • Acne Vulgaris • Dermatology • PPARG

GED-0507 attenuates lung fibrosis by counteracting myofibroblast transdifferentiation in vivo and in vitro. (PubMed, PLoS One) - "In a mouse model of bleomycin (BLM)-induced pulmonary fibrosis, we have demonstrated that the non-racemic selective PPAR-γ modulator GED-0507 is able to reduce body weight loss, ameliorate clinical and histological features of pulmonary fibrosis, and increase survival rate without any safety concerns. Compared with the US Food and Drug Administration-approved antifibrotic drugs pirfenidone and nintedanib, GED-0507 displayed greater antifibrotic activity by controlling alveolar epithelial cell dysfunction, EMT, and extracellular matrix remodeling. In conclusion, GED-0507 demonstrated potent antifibrotic properties and might be a promising drug candidate for the treatment of pulmonary fibrosis."

Journal • Preclinical • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • FN1 • TGFB1

PPARγ signaling protects hair follicle stem cells from chemotherapy-induced apoptosis and epithelial-mesenchymal transition. (PubMed, Br J Dermatol) - "A cyclophosphamide metabolite alone suffices to damage and deplete human scalp eHFSCs by promoting apoptosis, DNA damage, and EMT ex vivo. Therefore, pCIA-therapeutic strategies need to target these pathological processes. Our data introduce the stimulation of PPARγ signaling as a novel intervention strategy for the prevention of pCIA, given the ability of NAGED to prevent chemotherapy-induced eHFSCs damage ex vivo."

Journal • Alopecia • CDH1 • FN1 • PPARG • VIM

A CLINICAL STUDY TO EVALUATE THE LONG-TERM DERMAL SAFETY PROFILE OF 12-WEEKS TOPICAL ADMINISTRATION OF N-ACETYL-GED-0507-34-LEVO GEL 5% IN PATIENTS WITH FACIAL ACNE STUDIO CLINICO PER VALUTARE IL PROFILO DI SICUREZZA CUTANEA A LUNGO TERMINE DELLA SOMMINISTRAZIONE TOPICA PER 12 SETTIMANE DI N-ACETYL-GED-0507-34-LEVO GEL 5% IN PAZIENTI CON ACNE AL VOLTO (clinicaltrialsregister.eu) - P1; N=25; Completed; Sponsor: PPM SERVICES S.A.

Clinical • New P1 trial • Acne Vulgaris • Rheumatology

[VIRTUAL] GED-0507 as a Novel Potential Anti-Fibrotic Treatment Option for Pulmonary Fibrosis (ATS-I 2020) - "Materials and Methods : C57/BL6 mice (n=108) were randomized to phosphate buffered saline (PBS), bleomycin (BLM) 0.025U, BLM + GED-0507 (30 or 100 mg/Kg/day), BLM + Pirfenidone (Pirf) (60 or 400 mg/Kg/day) and BLM + Nintedanib (Nint) (60 mg/Kg/day), both in prophylactic and therapeutic administration. Our data support further development of GED-0507 as a potential treatment for human pulmonary fibrosis."

Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Inflammatory Bowel Disease • Interstitial Lung Disease • Respiratory Diseases • CDH1 • COL1A1