SFA-002 / SFA Therap - LARVOL DELTA

Comparison of Otezla to SFA-002 to Placebo in Plaque Psoriasis Patients (clinicaltrials.gov) - P2/3 | N=125 | Not yet recruiting | Sponsor: SFA Therapeutics

New P2/3 trial • Dermatology • Immunology • Psoriasis

Effectiveness of SFA-002 to inhibit TH1/TH17 inflammation in an experimental skin model (PRNewswire) - "In the human psoriasis-like model, histology and cytokine release profiles were obtained from human skin samples treated with SFA-002, apremilast, or betamethasone over six days. At the conclusion of the study, samples treated with SFA-002 displayed improved structural integrity with noticeable reductions in epidermal separation compared to untreated samples. Compared to untreated samples, samples treated with SFA-002 displayed statistically significant decreases in IL-17A levels (80%) comparable to decreases in IL-17A levels in samples treated with betamethasone (70%) and apremilast (95%)."

Preclinical • Psoriasis

Effectiveness of SFA002 to inhibit TH1/TH17 inflammation in an experimental skin model (AAD 2025) - "Compared to untreated InflammaSkin® controls, decreases in IL-17A levels across all test subjects betamethasone (70%), Apremilast (95%), and SFA002 (80%) were statistically significant. Overall SFA002 displayed similar effects as betamethasone and Apremilast in reducing inflammation in the PSO-InflammaSkin® model suggesting SFA002 may be an effective treatment for psoriasis."

Dermatology • Immunology • Inflammation • Psoriasis • IL17A • IL22

Profiling of Apremilast and SFA-002 in an Imiquimod (IMQ) Mouse Model of Psoriasis (PRNewswire) - "The results demonstrated a significant reduction in the severity of psoriasis, in-line with existing treatments etanercept and apremilast, as shown by the lowest change in skin thickening. These results suggest that SFA-002 may offer a promising new oral treatment option for individuals struggling with psoriasis by addressing both the inflammation and the visible symptoms...Mice dosed with SFA-002 experienced a statistically significant reduction in the disease severity score and prevention of skin thickening. Compared to apremilast, mice dosed with SFA-002 showed decreased levels of IL-17A in the ear skin only and decreased levels of IL-23 in plasma and ear skin while mice dosed with apremilast showed no change in IL-23 levels. Treatment with SFA-002 also showed a positive trend in reduction of Transepidermal Water Loss (TEWL), a typical phenomenon of psoriatic skin lesions."

Preclinical • Psoriasis

SFA Therapeutics Announces Positive Phase 1b Data of SFA-002 in Mild-to-Moderate Psoriasis (PRNewswire) - P1 | N=90 | NCT05642182 | Sponsor: SFA Therapeutics | "SFA Therapeutics, Inc...today announced positive data from its Phase 1b clinical trial of oral drug candidate SFA-002 in patients with mild-to-moderate psoriasis....SFA-002 met its primary endpoint of safety in the Phase 1b clinical trial. No treatment related adverse events or toxicities were observed during the treatment period, and no rebound effects were observed. SFA Therapeutics has filed its annual safety update with the U.S. Food and Drug Administration....SFA-002 met its exploratory endpoint of efficacy. Patients administered SFA-002 demonstrated statistically significant Psoriasis Area and Severity Index (PASI) percentage change and Investigator Global Assessment (IGA) score improvements compared to placebo....We look forward to the opportunity to investigate the Cohort 2 formulation of SFA-002 in patients with mild-to-moderate psoriasis in a Phase 2 clinical trial."

P1 data • Trial status • Psoriasis

Profiling of Apremilast and SFA002 in an Imiquimod Mouse Model of Psoriasis (AAD 2025) - "In addition, treatment with SFA002 also showed a positive trend in reduction of transepidermal water loss (TEWL), as typical phenomenon of psoriatic skin lesions. In conclusion, the results suggested that SFA002 should be further investigated as a new oral treatment for psoriasis."

Preclinical • Dermatology • Immunology • Psoriasis • IL17A • IL23A

Study of SFA002 in Patients with Mild to Moderate Psoriasis Plaques (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: SFA Therapeutics | N=30 ➔ 90 | Trial completion date: Jul 2024 ➔ Jul 2025 | Trial primary completion date: Jun 2024 ➔ Jul 2025

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

SFA Therapeutics Announces Completion of Enrollment in Phase 1b Trial of SFA-002 for Psoriasis (PRNewswire) - "SFA Therapeutics, Inc...today announced the completion of enrollment of 15 patients in cohort 2 of its Phase 1b clinical trial of SFA-002 for the treatment of mild-to-moderate chronic plaque psoriasis."

Enrollment closed • Immunology • Psoriasis

Study of SFA002 in Patients With Mild to Moderate Psoriasis Plaques (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: SFA Therapeutics | Trial completion date: Mar 2024 ➔ Jul 2024 | Trial primary completion date: Dec 2023 ➔ Jun 2024

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

SFA Therapeutics Announces Updated Psoriasis Data for SFA-002, Bridge Financing, and Foundational Patent (GlobeNewswire) - P1b | N=30 | NCT05642182 | Sponsor: SFA Therapeutics | "SFA Therapeutics...is pleased to announce the completion of a bridge financing of $4.5 million, led by North South Ventures...The proceeds from the financing allow for advancement of lead program SFA-002 through ongoing Phase 1b cohort 2 (15 additional psoriasis patients) with the final data expected in the first half of 2024 and planning for the Phase 2 clinical trial development...SFA-002 Phase 1b Cohort 1 Extension Analysis Highlights...92% of patients demonstrated a PASI improvement of greater than 50; 72% of subjects showed an improvement of greater than PASI 75...No related adverse events or toxicities were observed during the treatment period and follow-up, with no rebound effects observed....SFA Therapeutics was also recently granted a Composition of Matter patent, US patent number 11,759, 442 B2, issued on September 19, 2023."

Financing • P1 data • Patent • Immunology • Psoriasis

Study of SFA002 in Patients With Mild to Moderate Psoriasis Plaques (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: SFA Therapeutics | Trial completion date: Oct 2023 ➔ Mar 2024 | Trial primary completion date: Sep 2023 ➔ Dec 2023

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

SFA Therapeutics announces results for SFA-002 from Phase 1b Cohort 1 clinical trial for treatment of mild-to-moderate psoriasis (GlobeNewswire) - P1 | N=30 | NCT05642182 | Sponsor: SFA Therapeutics | "In 14 evaluable subjects (including 6 subjects on the 3-month extension) 85% of patients demonstrated a PASI improvement of greater than 50. 71% of subjects showed an improvement of greater than PASI 75. Two subjects achieved PASI 100 (100% clearance)...Clinically meaningful treatment effects included patients with difficult to treat scalp psoriasis and palmoplantar psoriasis....No related adverse events or toxicities were observed during the treatment period and follow-up, and no rebound effects were observed...A readout for cohort 2 is expected by year-end 2023."

P1 data • Immunology • Psoriasis

Study of SFA002 in Patients With Mild to Moderate Psoriasis Plaques (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: SFA Therapeutics | Trial completion date: Jul 2023 ➔ Oct 2023 | Trial primary completion date: Mar 2023 ➔ Sep 2023

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

SFA Therapeutics Announces FDA Clearance of IND Application for SFA-001N for the Treatment of NASH and Fibrosis (PRNewswire) - "SFA Therapeutics...announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to investigate SFA-001N in patients with non-alcoholic steatohepatitis (NASH) with or without fibrosis. SFA-001N is designed to act on multiple pathways involved in the pathogenesis of NASH....In addition to SFA-001N, SFA Therapeutics is investigating SFA-002 in a Phase 1b clinical trial for psoriasis and expects to complete enrollment in early 2023 and share topline data by the end of 2023."

Enrollment status • IND • P1 data • Fibrosis • Immunology • Non-alcoholic Steatohepatitis • Psoriasis

SFA Therapeutics Announces FDA Clearance for Amendment to Extend Phase 1b Trial of SFA-002 for Psoriasis (PRNewswire) - “SFA Therapeutics, Inc…announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with an extension to the ongoing Phase 1b clinical trial of SFA-002, an investigational drug candidate for psoriasis. The extension will allow responders to remain on SFA-002 treatment for an additional three month period.”

Trial status • Immunology • Psoriasis