According to the findings from a recent open label phase 2 study of bertilimumab for bullous pemphigoid, Immune Pharmaceuticals will expand its enrollment eligibility criteria to include steroid tapering resistant patients. The expansion is based on data from 3 patients who have completed treatment to date in the ten-patient study with bertilimumab.
Bullous pemphigoid, a rare autoimmune blistering disease of the skin, is painful and itchy. It occurs predominantly in patients more than 60 years of age. Bertilimumab, a first-in-class monoclonal antibody that blocks eotaxin-1, is a targeted therapy in inflammatory conditions.
In the study, the 3 patients had an average reduction of 84% in the Bullous Pemphigoid Disease Activity Index and oral prednisone was tapered down to 10 mg or less, according to a presentation at the 2017 American Academy of Dermatology meeting in Orlando, FL. In addition, no significant adverse events were reported. Based on these preliminary results, Immune Pharmaceuticals submitted a request for orphan drug designation for bertilimumab for bullous pemphigoid.
For the initial study, researchers examined patients who had recently been diagnosed with the condition. However, investigators in the study expressed a desire to allow entry of taper resistant patients, or those who are not newly diagnosed, but are having difficulty coming off chronic steroids. The initial findings support the ability to include taper resistant patients to better understand whether the ability to taper would improve when the patient is treated with bertilimumab, according to researchers.
According to the findings from a recent open label phase 2 study of bertilimumab for bullous pemphigoid, Immune Pharmaceuticals will expand its enrollment eligibility criteria to include steroid tapering resistant patients. The expansion is based on data from 3 patients who have completed treatment to date in the ten-patient study with bertilimumab.
Bullous pemphigoid, a rare autoimmune blistering disease of the skin, is painful and itchy. It occurs predominantly in patients more than 60 years of age. Bertilimumab, a first-in-class monoclonal antibody that blocks eotaxin-1, is a targeted therapy in inflammatory conditions.
In the study, the 3 patients had an average reduction of 84% in the Bullous Pemphigoid Disease Activity Index and oral prednisone was tapered down to 10 mg or less, according to a presentation at the 2017 American Academy of Dermatology meeting in Orlando, FL. In addition, no significant adverse events were reported. Based on these preliminary results, Immune Pharmaceuticals submitted a request for orphan drug designation for bertilimumab for bullous pemphigoid.
For the initial study, researchers examined patients who had recently been diagnosed with the condition. However, investigators in the study expressed a desire to allow entry of taper resistant patients, or those who are not newly diagnosed, but are having difficulty coming off chronic steroids. The initial findings support the ability to include taper resistant patients to better understand whether the ability to taper would improve when the patient is treated with bertilimumab, according to researchers.
According to the findings from a recent open label phase 2 study of bertilimumab for bullous pemphigoid, Immune Pharmaceuticals will expand its enrollment eligibility criteria to include steroid tapering resistant patients. The expansion is based on data from 3 patients who have completed treatment to date in the ten-patient study with bertilimumab.
Bullous pemphigoid, a rare autoimmune blistering disease of the skin, is painful and itchy. It occurs predominantly in patients more than 60 years of age. Bertilimumab, a first-in-class monoclonal antibody that blocks eotaxin-1, is a targeted therapy in inflammatory conditions.
In the study, the 3 patients had an average reduction of 84% in the Bullous Pemphigoid Disease Activity Index and oral prednisone was tapered down to 10 mg or less, according to a presentation at the 2017 American Academy of Dermatology meeting in Orlando, FL. In addition, no significant adverse events were reported. Based on these preliminary results, Immune Pharmaceuticals submitted a request for orphan drug designation for bertilimumab for bullous pemphigoid.
For the initial study, researchers examined patients who had recently been diagnosed with the condition. However, investigators in the study expressed a desire to allow entry of taper resistant patients, or those who are not newly diagnosed, but are having difficulty coming off chronic steroids. The initial findings support the ability to include taper resistant patients to better understand whether the ability to taper would improve when the patient is treated with bertilimumab, according to researchers.
