Forbius to Report Phase 1b Fibrosis Clinical Trial Results with AVID200, First-in-Class Selective TGF-beta Inhibitor, at EULAR 2020

  • AVID200 selectively targets TGF-beta 1 & 3, central mediators of fibrosis, while sparing TGF-beta 2 for optimal safety
  • AVID200 is being developed as an anti-fibrotic therapy across multiple indications
  • Phase 1b safety, anti-fibrotic activity, and biomarker results demonstrate AVID200’s potential to reverse established fibrosis in patients with systemic sclerosis and will be reported at EULAR 2020

Austin, TX, and Montreal, QC (Apr. 30, 2020)Forbius, a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer, announces it will report the first fibrosis clinical data with AVID200 at the Annual European Congress of Rheumatology (EULAR) 2020.

The Phase 1b clinical study in patients with diffuse cutaneous systemic sclerosis (AVID200-01, NCT03831438) is designed to assess the safety and initial anti-fibrotic activity of escalating doses of AVID200.

To date, 3 dose levels have been enrolled and completed treatment. The agent was well tolerated. Rapid and signficant reduction of skin fibrosis was observed across all dose levels at weeks 6 and 16, as quantified by the modified Rodnan Skin Score (MRSS). Larger reduction of skin fibrosis scores were observed at the highest doses, indicating a dose-response. Further, dose-dependent regulation of tissue and serum biomarkers of TGF-beta and fibrotic activity have been observed.

The Phase 1b safety and efficacy results support AVID200’s proposed anti-fibrotic mode of action as well as the company’s strategy to develop AVID200 across a broad range of fibrotic indications.

Full details will be reported at EULAR in a poster tour:

Time & Place:  Posters will be available for viewing beginning June 4. Further details on the program can be found here.

Session:  19 - Progress in scleroderma and myositis, poster tour, Presentation #THU0329

Title:  Safety, Target Engagement, and Initial Efficacy of AVID200, a First-in-Class Potent and Isoform-Selective Inhibitor of TGF-beta 1 and 3, in Patients with Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Phase 1 Dose Escalation Study

Presenter:  Dr. Robert Lafyatis, Professor of Medicine, Division of Rheumatology and Clinical Immunology, University of Pittsburgh


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About TGF-beta 1 & 3
TGF-beta 1 & 3 are central mediators of fibrosis, a leading cause of morbidity and mortality worldwide. TGF-beta 1 & 3 drive fibrosis by promoting the accumulation of extracellular matrix proteins in tissues; consequently their inhibition is proposed to have broad potential as an anti-fibrotic therapy across several indications with high unmet need.

About AVID200 and the AVID200-01 Trial (NCT03831438)
Systemic Sclerosis (SSc) is a rare, severe, and progressively debilitating fibrotic disease that predominately affects women in mid-life. The 10-year survival rate of SSc patients is approximately 55%. No therapeutic is currently approved for the treatment of SSc, which affects an estimated 90,000 people in the U.S. alone.

AVID200-01 (NCT03831438) is a Phase 1 open-label, dose-escalation study to evaluate safety, pharmacokinetics, pharmacodynamics, and anti-fibrotic activity of AVID200 in patients with documented diffuse cutaneous SSc.

About Forbius: Targeting TGF-beta and EGFR Pathways in Fibrosis and Cancer
Forbius is a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer. We are focused on the transforming growth factor-beta (TGF-beta) and epidermal growth factor receptor (EGFR) pathways.

Forbius’ team of TGF-beta biology experts designed a proprietary platform of TGF-beta inhibitors with best-in-class potency and selectivity against the principal disease-driving isoforms 1 & 3. This novel class of TGF-beta inhibitors has proven highly active in preclinical models of fibrosis and cancer and was well-tolerated in long-term toxicology studies. Forbius’ lead TGF-beta 1 & 3 inhibitor, AVID200, is undergoing Phase 1 clinical trials in two fibrotic indications as well as in solid tumors.

Forbius' lead program targeting EGFR is AVID100. AVID100 is an anti-EGFR antibody-drug conjugate (ADC) with a novel tumor-selective mode of action. This program is undergoing Phase 2a clinical trials in EGFR-overexpressing solid tumors.



Ilia Tikhomirov, CEO