ZURICH-SCHLIEREN, Switzerland I January 17, 2013 I Molecular Partners announced today that the results of a Phase I/II study evaluating the safety and preliminary activity of MP0112, a long-acting anti-VEGF DARPin, in patients with Diabetic Macular Edema (DME) have been published on-line in The American Journal of Ophthalmology (AJO).
MP0112 was shown to be safe, and to suppress VEGF-A concentrations in aqueous humor after a single intraocular injection, with a pharmacokinetic half-life of about 2 weeks. These effects were accompanied by a stabilization or improvement in visual acuity and reduction of retinal edema (measured with optical coherence tomography) for up to 12 to 16 weeks.
“The current 4 to 8 week dosing frequency of anti-VEGF therapies imposes a huge burden upon patients, physicians and healthcare systems. The ability to suppress intraocular VEGF for as long as possible is an important differentiator, and could result in a more sustainable treatment regimen in DME”, said Lisa Rojkjaer, M.D., Chief Medical Officer at Molecular Partners. “Publication of these exciting results in the high impact journal AJO underscores the importance of the data.”
DME together with wet AMD are key causes of severe vision loss in the western world. These two indications are driven primarily by elevated ocular concentrations of VEGF.
MP0112 is a highly-potent, stable and soluble anti-VEGF DARPin, a small therapeutic protein with single-digit picomolar binding affinity for VEGF-A. In 2011, Molecular Partners licensed the molecule under an exclusive agreement to Allergan, Inc. for clinical development in retinal diseases. Allergan is currently evaluating the molecule in a phase 2b trial in 200 patients with exudative AMD based on an optimized manufacturing process and formulation (AGN-150998). Data from this study are expected in 2013.
Notes to editors:
About Diabetic Macular Edema
Diabetic retinopathy is a major complication of diabetes mellitus and a leading cause of vision loss. Patients with diabetic retinopathy have elevated vascular endothelial growth factor (VEGF) levels in the vitreous and retina, causing vascular leakiness and breakdown of the blood-retinal barrier, with accumulation of fluid in the retina resulting in DME. Approved therapies for DME include laser photocoagulation and more recently, the VEGF-inhibitor Lucentis®. As the global prevalence of diabetes is estimated to reach 300 million worldwide by 2025, the number of patients with DME is expected to increase significantly.
About Molecular Partners AG
Molecular Partners is a privately-owned biotech company focusing on the research, development and commercialization of a novel class of biological drugs known as DARPins®. The company is committed to create medicines for diseases with unmet medical need and to dramatically improve existing therapies. DARPins® combine the high specificity, selectivity and safety of monoclonal antibodies with many advantages of small molecules, including high stability – and adding the ability of combining multiple specificities. Molecular Partners has established a strong DARPin® pipeline that is well differentiated from standard therapeutic approaches. Molecular Partners is focusing on DARPin® drugs in inflammation, oncology, ophthalmology and other disease areas. The most advanced DARPin® is MP0112. The internal pipeline is expanded by partnered programs with leading pharmaceutical companies. Molecular Partners has established collaborations with Allergan, Janssen Biotech and others. The company is backed by a strong syndicate of investors and holds a strong patent estate covering all DARPin® applications.
About DARPins®
DARPins® are a new generation of target-binding proteins which can be isolated from large libraries. The DARPin® platform is an efficient product generating engine creating differentiated and high quality drugs at unmatched speed. Each drug candidate profits from a wide range of beneficial biophysical properties, including high stability and solubility, high yield and low-cost microbial production. Also, DARPins® show very high potencies and pharmacokinetic profiles tailored to the demand of the application, ranging from minutes to weeks. DARPins® can be effortlessly combined into multispecific drug candidates without compromising biophysical and development characteristics. This rapid and robust generation of multispecific DARPins® allows new combinatorial approaches in exploring target biology.
SOURCE: Molecular Partners
Post Views: 525
ZURICH-SCHLIEREN, Switzerland I January 17, 2013 I Molecular Partners announced today that the results of a Phase I/II study evaluating the safety and preliminary activity of MP0112, a long-acting anti-VEGF DARPin, in patients with Diabetic Macular Edema (DME) have been published on-line in The American Journal of Ophthalmology (AJO).
MP0112 was shown to be safe, and to suppress VEGF-A concentrations in aqueous humor after a single intraocular injection, with a pharmacokinetic half-life of about 2 weeks. These effects were accompanied by a stabilization or improvement in visual acuity and reduction of retinal edema (measured with optical coherence tomography) for up to 12 to 16 weeks.
“The current 4 to 8 week dosing frequency of anti-VEGF therapies imposes a huge burden upon patients, physicians and healthcare systems. The ability to suppress intraocular VEGF for as long as possible is an important differentiator, and could result in a more sustainable treatment regimen in DME”, said Lisa Rojkjaer, M.D., Chief Medical Officer at Molecular Partners. “Publication of these exciting results in the high impact journal AJO underscores the importance of the data.”
DME together with wet AMD are key causes of severe vision loss in the western world. These two indications are driven primarily by elevated ocular concentrations of VEGF.
MP0112 is a highly-potent, stable and soluble anti-VEGF DARPin, a small therapeutic protein with single-digit picomolar binding affinity for VEGF-A. In 2011, Molecular Partners licensed the molecule under an exclusive agreement to Allergan, Inc. for clinical development in retinal diseases. Allergan is currently evaluating the molecule in a phase 2b trial in 200 patients with exudative AMD based on an optimized manufacturing process and formulation (AGN-150998). Data from this study are expected in 2013.
Notes to editors:
About Diabetic Macular Edema
Diabetic retinopathy is a major complication of diabetes mellitus and a leading cause of vision loss. Patients with diabetic retinopathy have elevated vascular endothelial growth factor (VEGF) levels in the vitreous and retina, causing vascular leakiness and breakdown of the blood-retinal barrier, with accumulation of fluid in the retina resulting in DME. Approved therapies for DME include laser photocoagulation and more recently, the VEGF-inhibitor Lucentis®. As the global prevalence of diabetes is estimated to reach 300 million worldwide by 2025, the number of patients with DME is expected to increase significantly.
About Molecular Partners AG
Molecular Partners is a privately-owned biotech company focusing on the research, development and commercialization of a novel class of biological drugs known as DARPins®. The company is committed to create medicines for diseases with unmet medical need and to dramatically improve existing therapies. DARPins® combine the high specificity, selectivity and safety of monoclonal antibodies with many advantages of small molecules, including high stability – and adding the ability of combining multiple specificities. Molecular Partners has established a strong DARPin® pipeline that is well differentiated from standard therapeutic approaches. Molecular Partners is focusing on DARPin® drugs in inflammation, oncology, ophthalmology and other disease areas. The most advanced DARPin® is MP0112. The internal pipeline is expanded by partnered programs with leading pharmaceutical companies. Molecular Partners has established collaborations with Allergan, Janssen Biotech and others. The company is backed by a strong syndicate of investors and holds a strong patent estate covering all DARPin® applications.
About DARPins®
DARPins® are a new generation of target-binding proteins which can be isolated from large libraries. The DARPin® platform is an efficient product generating engine creating differentiated and high quality drugs at unmatched speed. Each drug candidate profits from a wide range of beneficial biophysical properties, including high stability and solubility, high yield and low-cost microbial production. Also, DARPins® show very high potencies and pharmacokinetic profiles tailored to the demand of the application, ranging from minutes to weeks. DARPins® can be effortlessly combined into multispecific drug candidates without compromising biophysical and development characteristics. This rapid and robust generation of multispecific DARPins® allows new combinatorial approaches in exploring target biology.
SOURCE: Molecular Partners
Post Views: 525
