A 6-month, Phase II, Double-masked, Multicenter, Randomized, Placebo Controlled, Parallel Group Study to Assess the Safety and Efficacy of Topical Administration of Two Concentrations of FOV2304 (High Dose or Low Dose) for the Treatment of Center-involving Clinically Significant Macular Edema Associated With Diabetic Retinopathy

The purpose of the study is to determine whether concentrations of FOV2304 (high dose or low dose) administered in the eye are more effective than placebo in treating patients with diabetic macular edema, following 12 weeks of treatment.

Start Date01 May 2011

Sponsor / Collaborator

Fovea Pharmaceuticals SA

100 Clinical Results associated with Safotibant

100 Translational Medicine associated with Safotibant

100 Patents (Medical) associated with Safotibant

Literatures (Medical) associated with Safotibant

01 Jul 2010·IDrugs : the investigational drugs journal

Association for Research in Vision and Ophthalmology (ARVO)--2010 Annual Meeting. For Sight: The Future of Eye and Vision Research--part 1.

Author: Hookes, Livia

The 2010 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO), held in Fort Lauderdale, FL, USA, included topics covering new therapeutic developments in the field of eye and vision research. This conference report highlights selected presentations on the development of FOV-2304 (Fovea Pharmaceuticals SA) for the potential treatment of diabetic macular edema; PHA-666859 (Pfizer Inc) for diabetic retinopathy; GTx-878 (GTx Inc) and FCFD-4514S (Genentech Inc) for age-related macular degeneration; SYL-040012 (Sylentis Sau) for ocular hypertension associated with open-angle glaucoma; PEG-PLA-TNP-470 (Harvard Medical School) for ocular neovascularization; recombinant galectin-3 (Senju Pharmaceutical Co Ltd) for corneal injury; and CellBead Neuro (CellMed Inc) for neurological trauma and neurodegeneration.

01 May 2010·Current opinion in investigational drugs (London, England : 2000)

Targeting the kallikrein-kinin system as a new therapeutic approach to diabetic retinopathy.

Review

Author: Sahel, José-Alain ; Combal, Jean-Philippe ; Bélichard, Pierre ; Pruneau, Didier

Diabetic retinopathy (DR) is a major microvascular complication of diabetes mellitus that can lead to visual impairment and blindness. There is no approved pharmacological treatment for DR; however, laser therapy, steroids and anti-VEGF agents appear to provide some benefit. Hyperglycemia, advanced glycation end products, growth factors, and elevated levels of circulating and vitreous cytokines and chemokines can all trigger an inflammatory response of the retinal vasculature. Features of DR can include diabetic macular edema, microhemorrhage, loss of capillaries, development of avascular areas and the vitreo-retinal proliferation of neovessels. The kallikrein-kinin system (KKS) has long been recognized as a key player of inflammatory processes in various organs. Intravitreally administered recombinant plasma kallikrein has been demonstrated to produce retinal vascular leakage and hemorrhage, while both kinin B1 and B2 receptor agonists have induced retinal edema. Furthermore, kallikrein inhibitors and peptide-based B1 receptor antagonists could reduce or block retinal vascular permeability in diabetic rats. In a diabetic rat model, FOV-2304 (Fovea Pharmaceuticals SA), a non-peptide selective B1 receptor antagonist, consistently blocked retinal vascular permeability, inhibited leukocyte adhesion and abolished the retinal mRNA expression of several inflammatory mediators. Although additional studies are required to investigate the role of the KKS in early capillary loss and late-stage neovascularization processes, the blockade of the KKS is a promising therapeutic strategy for DR.

01 Jul 2006·The Journal of Pharmacology and Experimental TherapeuticsQ3 · MEDICINE

Antinociceptive Pharmacology of N-[[4-(4,5-Dihydro-1 H-imidazol-2-yl)phenyl]methyl]-2-[2-[[(4-methoxy-2,6-dimethylphenyl) sulfonyl]methylamino]ethoxy]-N-methylacetamide, Fumarate (LF22-0542), a Novel Nonpeptidic Bradykinin B1 Receptor Antagonist

Q3 · MEDICINE

Article

Author: Porreca, F. ; Dodey, P. ; Peyrou, V. ; Pruneau, D. ; Junien, J.-L. ; Luccarini, J. M. ; Vanderah, T. W. ; Barth, M. ; Guo, W.

The antinociceptive pharmacology of N-[[4-(4,5-dihydro-1H-imidazol-2-yl)phenyl]methyl]-2-[2-[[(4-methoxy-2,6-dimethylphenyl) sulfonyl]methylamino]ethoxy]-N-methylacetamide fumarate (LF22-0542), a novel nonpeptidic B1 antagonist, was characterized. LF22-0542 showed high affinity for human and mouse B1 receptors with virtually no affinity for the human B2 receptor; a selectivity index of at least 4000 times was obtained when LF22-0542 was profiled throughout binding or cell biology assays on 64 other G-protein-coupled receptor, 10 ion channels, and seven enzymes. LF22-0542 was a competitive B1 receptor antagonist and elicited significant antinociceptive actions in the mouse acetic acid-induced writhing assay, as well as in the second phases of formalin-induced nociception in mice and in both the first and second phases of the formalin response in rats. LF22-0542 was active after s.c. but not p.o. administration. In B1 receptor knockout (KO) mice, acetic acid and formalin responses were significantly reduced and LF22-0542 had no additional effects in these animals. LF22-0542 alleviated thermal hypersensitivity in both acute (carrageenan) and persistent inflammatory (complete Freund's adjuvant) pain models in rats. LF22-0542 produced a full reversal of experimental neuropathic thermal hypersensitivity but was inactive in reversing nerve injury-induced tactile hypersensitivity in rats. In agreement with this observation, B1 KO mice subjected to peripheral nerve injury did not show thermal hypersensitivity but developed nerve injury-induced tactile hypersensitivity normally. The data demonstrate the antihyperalgesic actions of a selective systemically administered B1 receptor antagonist and suggest the utility of this class of agents for the treatment of inflammatory pain states and for some aspects of neuropathic pain.

100 Deals associated with Safotibant

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic macular oedema	Phase 2	Germany	Fovea Pharmaceuticals SA	01 May 2011
Diabetic macular oedema	Phase 2	Belgium	Fovea Pharmaceuticals SA	01 May 2011
Diabetic macular oedema	Phase 2	United States	Fovea Pharmaceuticals SA	01 May 2011
Diabetic macular oedema	Phase 2	Israel	Fovea Pharmaceuticals SA	01 May 2011
Diabetic macular oedema	Phase 2	Australia	Fovea Pharmaceuticals SA	01 May 2011
Diabetic macular oedema	Phase 2	Czechia	Fovea Pharmaceuticals SA	01 May 2011
Diabetic macular oedema	Phase 2	France	Fovea Pharmaceuticals SA	01 May 2011
Diabetic macular oedema	Phase 2	Poland	Fovea Pharmaceuticals SA	01 May 2011
Diabetic macular oedema	Phase 2	Spain	Fovea Pharmaceuticals SA	01 May 2011
Diabetic macular oedema	Phase 2	Italy	Fovea Pharmaceuticals SA	01 May 2011

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