Adheron Therapeutics Announces Favorable Phase 1 Clinical Trial Results
1/8/2014 9:28:00 AM
SAN FRANCISCO, Jan. 8, 2014 /PRNewswire/ -- Adheron Therapeutics, a biotechnology company which focuses on leveraging pioneering technology that disrupts cell adhesion to treat a variety of diseases, announced the completion of the company's Phase 1 clinical trial for its leading Cad-11 inhibitor SDP051. Cad-11 acts as a key mediator of joint destruction in rheumatoid arthritis, and is also an important contributor to fibrotic pathology. These are disease pathways that Adheron Therapeutics is particularly interested in pursuing.
SDP051 is a humanized monoclonal antibody to Cadherin-11, which acts as an "adhesive" between cells. Changes in Cad-11 interactions can induce cells to produce proteins that influence the cellular environment. The recently completed SDP051 trial was designed to assess the safety and tolerability of an escalating single dose of the compound in healthy volunteers who received SDP051 or placebo. The trial also assessed the pharmacokinetic properties of the protein in vivo.
Results from the Phase 1 trial show that SDP051 is safe and well-tolerated at doses up to 10 mg/kg per day with no evidence of significant side effects.
"The results from this trial meet and even exceed our expectations for safety, and provide evidence for an excellent dosing schedule," said Hari Kumar, CEO of Adheron Therapeutics. "The favorable profile lays the foundation for us to evaluate once monthly dosing in a Phase 2 trial, which we expect to start in 2015."
Cadherin-11 (Cad-11) is a surface protein expressed on fibroblasts in the skin and lungs, and fibroblast-like synoviocytes (FLS) in the joints. Cad-11 acts as an "adhesive" between cells, and changes in Cad-11 interactions can induce the cells to produce proteins that influence the cellular environment. Research completed in the laboratory of Michael Brenner, MD, at Brigham and Women's Hospital and Harvard Medical School has implicated Cad-11 in the disease processes leading to rheumatoid arthritis. Work initiated in Dr. Brenner's laboratory by Dr. Sandeep Agarwal, now at Baylor College of Medicine, has also demonstrated that Cad-11 plays a role in diverse fibrotic diseases.
A recent study published in OncoTarget and led by investigators at Georgetown University Medical Center, showed that Cad-11 is significantly over-produced in two very different diseasesrheumatoid arthritis and a variety of cancers, including breast and brain tumors.
For more information: http://explore.georgetown.edu/news/?ID=73435&PageTemplateID=295
About Adheron Therapeutics
Adheron Therapeutics is a biotechnology company focused on leveraging pioneering technology that disrupts cell adhesion to treat a variety of diseases. Founded by Dr. Brenner and Dr. Lee of Harvard Medical School, the company is led by industry veterans Bob Baltera (executive chairman) and Hari Kumar, PhD (CEO), and funded by a group of venture investors comprising Health Care Ventures, MedImmune Ventures, Partners Innovation Fund, Amgen Ventures, and SROne.
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