asengeprast (FT011) / Certa Therap - LARVOL DELTA

Certa Therapeutics Announces International Non-Proprietary Name for its First-in-class GPR68 Inhibitor Asengeprast (FT011) (GlobeNewswire) - "Certa Therapeutics (Certa)...announces that its lead candidate FT011 has been granted the International Non-Proprietary Name (INN) of ‘asengeprast’ by the World Health Organisation (WHO). Commonly known as a generic name, an INN is a globally recognised, unique name for a pharmaceutical substance or active ingredient."

Clinical • Fibrosis • Immunology • Scleroderma • Systemic Sclerosis

Certa Therapeutics Receives EU Orphan Designation for FT011, a GPR68 Inhibitor Being Developed as an Anti-Fibrotic Treatment for Systemic Sclerosis (GlobeNewswire) - "Certa Therapeutics...today announces that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) for its lead drug candidate, FT011, as a potential treatment of Systemic Sclerosis (SSc). Certa has previously also received ODD and Fast Track designation for FT011 as a potential treatment of SSc from the U.S. Food and Drug Administration (FDA)...An extensive body of data demonstrates promising efficacy in multiple in vitro and in vivo models of inflammatory and fibrotic disease. Phase I and IIa clinical studies in patients with SSc have also demonstrated favourable efficacy, safety and pharmacokinetics...Certa is planning for a Phase IIb confirmatory SSc clinical trial with FT011, bringing the company closer to providing better treatment options for patients with fibrosis."

Orphan drug • Immunology • Scleroderma • Systemic Sclerosis

EFFECT OF FT011 TREATMENT ON REVISED CRISS-25 AND GENE EXPRESSION IN SKIN BIOPSIES FROM PATIENTS WITH DIFFUSE CUTANEOUS SYSTEMIC SCLEROSIS (EULAR 2024) - P2 | "FT011 shows promising efficacy after 12 weeks of treatment using a new composite score, CRISS-25, and this clinical benefit coincides with a downregulation of fibrotic genes and pathways in SSc skin."

Biopsy • Clinical • Chronic Kidney Disease • Fibrosis • Immunology • Inflammation • Nephrology • Renal Disease • Rheumatology • Scleroderma • Systemic Sclerosis

Certa Therapeutics’ FT011 Granted US FDA Fast Track for the Treatment of Systemic Sclerosis (GlobeNewswire) - "Certa Therapeutics...today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational therapy FT011 for the treatment of systemic sclerosis (scleroderma), having previously granted Orphan Drug Designation....The Fast Track Designation was granted based on results of the previously announced Phase 2 study which indicated that treatment of scleroderma patients..."

Fast track designation • Systemic Sclerosis

Effects of FT011 in Systemic Sclerosis (clinicaltrials.gov) - P2 | N=30 | Completed | Sponsor: Certa Therapeutics | Active, not recruiting ➔ Completed

Trial completion • Fibrosis • Immunology • Scleroderma • Systemic Sclerosis

FT011 showed promising effects on disability, lung function in trial (Scleroderma News) - P2 | N=30 | NCT04647890 | Sponsor: Certa Therapeutics | "Treatment with FT011 led to clinically meaningful improvements in physical disability and lung function for some scleroderma patients given the experimental therapy in a Phase 2 clinical trial....'The Phase 2 trial demonstrates promising efficacy and safety data for FT011 after 12 weeks of treatment and certainly warrants a further study to assess the potential of FT011 to improve clinical outcomes for scleroderma patients'....The mean ACR-CRISS score was significantly higher in the high-dose FT011 group compared with the placebo group (0.542 vs. 0.131 points), suggestive of less severe disease for patients given the experimental treatment."

P2 data • Immunology • Scleroderma • Systemic Sclerosis

Certa Therapeutics presents positive data from a Phase 2 clinical study highlighting the potential benefit of FT011 as a novel treatment for scleroderma (GlobeNewswire) - P2 | N=30 | NCT04647890 | Sponsor: Certa Therapeutics | "Certa Therapeutics (Certa)...announces the presentation of results of its Phase 2 clinical trial of FT011 in patients with scleroderma at ACR Convergence 2023, the annual scientific meeting of the American College of Rheumatology being held in San Diego, California (10 – 15 November 2023)....The positive clinical trial data was presented by study investigator Professor Chris Denton MD (University College London, UK), describing that treatment with FT011 for 12 weeks resulted in a clinically meaningful improvement in 60% of patients treated with FT011 400mg (p = 0.019 vs. placebo) and 20% of patients in the FT011 200mg group compared with 10% in the placebo group....The company intends to start the pivotal study in late-2024."

New P3 trial • P2 data • Immunology • Scleroderma • Systemic Sclerosis

Certa Therapeutics presents positive data from a Phase 2 clinical study highlighting the potential benefit of FT011 as a novel treatment for scleroderma (BioSpace) - "Professor Dinesh Khanna MD...said, 'The mechanism of action for FT011 offers an important point of difference for the scleroderma research field as the upstream inhibition of inflammation and fibrosis may offer meaningful clinical outcomes. It is important to advance safe and effective treatments through clinical development, given the limited therapeutic options for scleroderma patients. I look forward to collaborating with the company in the FT011 development program ahead.'"

Media quote • Scleroderma • Systemic Sclerosis

FT011 for the Treatment of Systemic Sclerosis. Results from a Phase II Study (ACR Convergence 2023) - P2 | "These results demonstrate promising efficacy and safety data for FT011 OD after 12 weeks of treatment and therefore warrants a confirmatory phase III study to assess its potential to improve this debilitating condition."

P2 data • Fibrosis • Immunology • Inflammation • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Rheumatology • Scleroderma • Systemic Sclerosis

Certa Therapeutics' FT011 Granted US FDA Orphan Drug Designation for the Treatment of Systemic Sclerosis (PRNewswire) - "Certa Therapeutics...announces that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for its investigational therapy FT011 for the treatment of systemic sclerosis (scleroderma)....Data from the Phase 2 study will be presented at the American College of Rheumatology Annual Meeting 2023 (ACR Convergence), taking place between 10-15 November 2023, in San Diego CA."

Orphan drug • P2 data • Immunology • Scleroderma • Systemic Sclerosis

Orphan Designation: Treatment of systemic sclerosis (FDA) - Date Designated: 10/10/2023

Orphan drug • Immunology • Systemic Sclerosis

Ground-breaking results in Phase 2 scleroderma study by Certa Therapeutics demonstrates improvement in more than 60% of patients (PRNewswire) - "Data from Certa Therapeutics' Phase 2 clinical trial with development candidate FT011 demonstrates clinically meaningful improvements for more than 60 percent of patients with scleroderma after 12 weeks of treatment; Clinically meaningful improvements were reported in CRISS (the key composite endpoint for systemic sclerosis) lung function, SHAQ-DI and Physician Global Assessment."

P2 data • Fibrosis • Immunology • Scleroderma • Systemic Sclerosis

Identification of Noninvasive Surrogates as Predictors of Response to FT011 in Kidney Disease (KIDNEY WEEK 2022) - "Conclusion FT011 treatment reduced a fibrosis-associated transcriptional profile in the STNx rat model. The signature was highly significant in human kidney disease profiles, associated with more advanced disease, and strongly correlated with non-invasive biomarkers, offering a promise of identifying patients with an intrarenal profile best responsive to FT011 in clinical trials."

Fibrosis • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Immunology • Nephrology • Renal Disease

Certa Therapeutics' investigational drug FT011 delivers breakthrough results as a potential novel treatment for serious inflammatory and fibrotic diseases (PRNewswire) - "New research presented today by the University of Michigan reveals ground-breaking results for Certa Therapeutics' FT011, a novel potential treatment of serious inflammatory and fibrotic diseases....Top line data from Certa Therapeutics' phase II trial in scleroderma patients is expected to be released in early 2023."

P2 data • Immunology • Scleroderma • Systemic Sclerosis

Effects of FT011 in Systemic Sclerosis (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: Certa Therapeutics | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2022 ➔ Nov 2022 | Trial primary completion date: Mar 2022 ➔ Oct 2022

Enrollment closed • Trial completion date • Trial primary completion date • Fibrosis • Immunology • Scleroderma • Systemic Sclerosis

Effects of FT011 in Systemic Sclerosis (clinicaltrials.gov) - P2; N=30; Recruiting; Sponsor: Certa Therapeutics; Not yet recruiting ➔ Recruiting; Initiation date: Feb 2021 ➔ Jul 2021

Clinical • Enrollment open • Trial initiation date • Fibrosis • Immunology • Scleroderma • Systemic Sclerosis

Certa Therapeutics announces new clinical trial of investigative candidate (Mirage News) - "Certa Therapeutics has announced the launch of a Phase 2 trial in Australia for a potential new treatment for Diffuse Systemic Scleroderma...The Phase 2 trial of orally administered treatment, FT011, is commencing at St Vincent’s Hospital in Melbourne and at the Royal Adelaide Hospital in Adelaide. Up to 30 patients who have had the disease for less than five years are required for the study. The trial is for three months and will require a number of visits to the clinic."

Trial status • Immunology • Scleroderma • Systemic Sclerosis

FT011 for Scleroderma FT011 para la esclerodermia (clinicaltrialsregister.eu) - P2; N=30; Ongoing; Sponsor: Certa Therapeutics Pty Ltd

New P2 trial • Fibrosis • Immunology • Scleroderma • Systemic Sclerosis

Effects of FT011 in Systemic Sclerosis (clinicaltrials.gov) - P2; N=30; Not yet recruiting; Sponsor: Certa Therapeutics

Clinical • New P2 trial • Fibrosis • Immunology • Scleroderma • Systemic Sclerosis

Fibrotech announces positive phase Ia results for anti-fibrotic FT011 (Businesswire) - P1, N=48; "Fibrotech...announced that its lead anti-fibrotic compound FT011 has successfully completed a Phase Ia trial in healthy volunteers...All stages of the study demonstrated the safety and tolerability of FT011 with a once daily pharmacokinetic profile and no food effects or any observed adverse events....Fibrotech [also] announced the commencement of a Phase Ib trial involving patients with diabetic nephropathy associated with Type 1 or Type 2 diabetes."

New P1 trial • P1 data • Fibrosis

Oral delivery of the anti-fibrotic, FT011, achieves safe and robust intraocular levels of exposure in subjects undergoing glaucoma filtration surgery (ARVO 2020) - "After 4 weeks of dosing, there were no FT011-related adverse reactions and drug tolerance was high.Conclusions Oral delivery of FT011 achieved safe and robust exposure levels in AH and TC and 28 days of dosing was well-tolerated. A follow up study is required to determine if FT011 improves the safety and efficacy of GFS by improving the wound healing process over standard of care."

Clinical