Santarus announced that it has initiated a Phase I clinical study with SAN-300, its anti-VLA-1 antibody
SAN DIEGO, CA, USA | March 10, 2011 | Santarus, Inc. (NASDAQ:SNTS – News), a specialty biopharmaceutical company, today announced that it has initiated a Phase I clinical study with SAN-300, its anti-VLA-1 antibody. The randomized, placebo-controlled, blinded, single-center, single-dose, dose-escalation study is being conducted in Australia in a total of approximately 60 subjects, including healthy volunteers and two cohorts of patients with rheumatoid arthritis. The objectives of the study are to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of SAN-300. The company expects to complete this Phase I clinical study with SAN-300 in the first half of 2012.
“We believe SAN-300 represents a novel approach to autoimmune and inflammatory disease therapy with potential applicability in multiple diseases, including rheumatoid arthritis, inflammatory bowel disease, psoriasis and organ transplantation,” said Santarus president and chief executive officer Gerald T. Proehl.
Santarus senior vice president of clinical research Mark C. Totoritis, M.D., said, “SAN-300 targets a major collagen receptor, VLA-1 (α1β1 integrin), and has shown activity in multiple preclinical models of inflammation. This integrin, a cell adhesion molecule, plays a key role in the migration, retention and proliferation of activated T cells and monocytes at sites of chronic inflammation.”
Santarus acquired the exclusive worldwide rights to SAN-300 in September 2010, through the acquisition of closely held Covella Pharmaceuticals, Inc., and a related amended license agreement with Biogen Idec. The anti-VLA-1 antibody was initially developed by Biogen Idec and licensed to Covella in January 2009.
About Santarus
Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists. The company’s current commercial efforts are focused on GLUMETZA® (metformin hydrochloride extended release tablets) and CYCLOSET® (bromocriptine mesylate) tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Santarus also has a diverse development pipeline with three late-stage product candidates in Phase III clinical programs: budesonide MMX® for induction of remission of active ulcerative colitis, RHUCIN® (recombinant human C1 inhibitor) for treatment of acute attacks of hereditary angioedema and rifamycin SV MMX® for treatment of travelers’ diarrhea, in addition to other earlier-stage development programs. More information about Santarus is available on the company’s website at www.santarus.com.
SOURCE: Santarus
Post Views: 28
Santarus announced that it has initiated a Phase I clinical study with SAN-300, its anti-VLA-1 antibody
SAN DIEGO, CA, USA | March 10, 2011 | Santarus, Inc. (NASDAQ:SNTS – News), a specialty biopharmaceutical company, today announced that it has initiated a Phase I clinical study with SAN-300, its anti-VLA-1 antibody. The randomized, placebo-controlled, blinded, single-center, single-dose, dose-escalation study is being conducted in Australia in a total of approximately 60 subjects, including healthy volunteers and two cohorts of patients with rheumatoid arthritis. The objectives of the study are to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of SAN-300. The company expects to complete this Phase I clinical study with SAN-300 in the first half of 2012.
“We believe SAN-300 represents a novel approach to autoimmune and inflammatory disease therapy with potential applicability in multiple diseases, including rheumatoid arthritis, inflammatory bowel disease, psoriasis and organ transplantation,” said Santarus president and chief executive officer Gerald T. Proehl.
Santarus senior vice president of clinical research Mark C. Totoritis, M.D., said, “SAN-300 targets a major collagen receptor, VLA-1 (α1β1 integrin), and has shown activity in multiple preclinical models of inflammation. This integrin, a cell adhesion molecule, plays a key role in the migration, retention and proliferation of activated T cells and monocytes at sites of chronic inflammation.”
Santarus acquired the exclusive worldwide rights to SAN-300 in September 2010, through the acquisition of closely held Covella Pharmaceuticals, Inc., and a related amended license agreement with Biogen Idec. The anti-VLA-1 antibody was initially developed by Biogen Idec and licensed to Covella in January 2009.
About Santarus
Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists. The company’s current commercial efforts are focused on GLUMETZA® (metformin hydrochloride extended release tablets) and CYCLOSET® (bromocriptine mesylate) tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Santarus also has a diverse development pipeline with three late-stage product candidates in Phase III clinical programs: budesonide MMX® for induction of remission of active ulcerative colitis, RHUCIN® (recombinant human C1 inhibitor) for treatment of acute attacks of hereditary angioedema and rifamycin SV MMX® for treatment of travelers’ diarrhea, in addition to other earlier-stage development programs. More information about Santarus is available on the company’s website at www.santarus.com.
SOURCE: Santarus
Post Views: 28
