Rational Drug Design of New Chemical Entities.

New Chemical Entity

GED-0507-34-Levo (Code: GED-0507) is a patent protected New Chemical Entity, under development by Nogra Pharma for the treatment of Idiopathic Pulmonary Fibrosis (IPF) as main indication, and having the treatment of post-COVID-19 lung inflammation and fibrosis as possible additional indication.

GED-0507 is a new well tolerated amino-phenyl-methoxy-propionic acid, that was originally designed with the aim of obtaining a safe anti-inflammatory compound for the treatment of Ulcerative Colitis.

GED-0507 has completed the nonclinical development stage and is ready to enter the clinical development stage.


Target ID

Lead ID & Preclinical

Formulation Development

Clinical Phase l

Clinical Phase lI

Clinical Phase lII



Anti-inflammatory activity

Its anti-inflammatory activity was demonstrated in mouse models of colitis and in vitro in:

a) intestinal epithelial cell lines,

b) in a sebocyte cell line, and

c) in primary human keratinocytes.

Anti-fibrotic effects

Anti-fibrotic effects were first demonstrated in a mouse model of inflammation-driven intestinal fibrosis and in vitro in primary human intestinal fibroblasts from Ulcerative Colitis (UC) patients. (

Moreover, in the bleomycin-induced lung fibrosis mouse model, GED-0507 was able both in a preventive and in a therapeutic mode, to significantly reduce lung fibrosis. Statistically significant results were obtained on several endpoints versus either pirfenidone or nintedanib, the two products approved for the treatment of IPF. (

Then, the activity of GED-0507 on various inflammatory/ fibrotic pathways was further evaluated GED-0507 in the BLM mouse model reduced the expression of markers of inflammation and of fibrosis, and inhibited epithelial-to-mesenchimal transition. ( 10.1371/journal.pone.0257281)

Idiopathic Pulmonary Fibrosis

Based on the collected data, GED-0507 obtained by EMA in 2018 the Orphan Drug Designation for the treatment of Idiopathic Pulmonary Fibrosis (Community Register of Orphan Medicinal Products No.EU/3/18/2056) on the grounds of the Sponsor having provided “sufficient justification for the assumption that the medicinal product containing GED-0507 will be of significant benefit to those affected by the condition”.

GED-0507 has completed the nonclinical development stage and is ready to enter the clinical development stage for IPF.

An immediate-release oral solid dosage form (tablet) has been developed for the treatment of IPF in two dose strengths of 250 and 500 mg GED-0507/tablet.

The available comprehensive package of nonclinical and clinical safety data support the initiation of a Phase Ib chronic study in patients affected by IPF.


More recently, data have been gathered which support the possible use of GED-0507 for lung injury caused by SARS-CoV-2 virus.

SARS-CoV2 uses the ACE2 receptor for its internalization,

  • The effects of GED-0507 have been evaluated on the expression of the anti-inflammatory receptor ACE2 and other key inflammatory mediators expressed during COVID-19 disease in a murine model of lung inflammation/fibrosis induced by bleomycin.
  • New biological functions of GED-0507 have been identified through an induction of ACE2 and MasR, and the decreased expression of TACE and ERK1.
  • Data suggest also that GED could have potential therapeutic efficacy in COVID19 according to its known effects on key factors sustaining SARS-CoV2 pathogenicity in vulnerable patients.

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