NEW YORK, Sept. 19, 2014 /PRNewswire/ -- Transparency Life Sciences, LLC (TLS), the world's first clinical-stage drug development company based on open innovation, today announced that it is applying its expertise in crowdsourcing and digital telemonitoring technology to conduct a clinical trial of Auven Therapeutics' Kiacta in patients with sarcoidosis, a rare systemic inflammatory disease. Kiacta is an orally bioavailable small molecule that is in a final Phase III confirmatory trial for the treatment of AA amyloidosis.
TLS aims to revolutionize clinical drug development in three ways: by soliciting crowdsourced expertise to improve the design of clinical trials, by replacing patient site visits with telemonitoring and other remote digital technologies, and by operating with full data transparency. The goal is more patient-centric, transparent and dramatically less costly clinical development.
"Transparency's focus on crowdsourced design and home-based data collection promises to make clinical trials for orphan indications far more feasible, by aligning clinical endpoints with clinical practice while minimizing geographical barriers," noted Marc Foster, co-founder and COO of Transparency Life Sciences. "Kiacta has shown promising efficacy in the systemic inflammatory disease AA amyloidosis, and we are pleased to have the opportunity to assess it as a potential therapy for sarcoidosis, an orphan indication that has few current treatment options."
TLS is developing the clinical protocol for the Kiacta study using its Protocol Builder, a proprietary online tool that invites structured input from researchers, physicians and patients to design clinical trials that have greater relevance to patient experience and clinical practice. TLS is also soliciting input from sarcoidosis patient and physician communities through collaborations with the Foundation for Sarcoidosis Research and Inspire, an online patient engagement platform.
The trial will minimize the need for patient site visits by primarily relying on remote data collection using a variety of telemonitoring tools. TLS is partnering with AMC Health, a comprehensive provider of telemedicine services, to help conduct the study.
Kiacta is in Phase lll development for the treatment of AA amyloidosis, an orphan indication that often leads to kidney dialysis and death. Kiacta was originally developed by BELLUS Health. Auven Therapeutics acquired worldwide rights to Kiacta in 2010 and is responsible for designing, financing and conducting the Kiacta development program. Preclinical research demonstrates that Kiacta may interrupt a critical pathway in the development of sarcoidosis.
About Sarcoidosis
Sarcoidosis is a systemic disease involving abnormal collections of inflammatory cells (granulomas) that form in multiple organs. The granulomas are most often located in the lungs, but any organ can be affected. Sarcoidosis is likely caused by a prolonged immune reaction to an infection or other trigger in susceptible individuals. In many cases it clears up without medical intervention, but sarcoidosis can go on to affect the patient adversely over the long-term, and can become disabling or life-threatening. Current treatments such as non-steroidal anti-inflammatory drugs and corticosteroids can help relieve symptoms, but do not alter the course of the disease.
About Transparency Life Sciences
Transparency Life Sciences (TLS) is the world's first clinical-stage drug development company based on open innovation. TLS acquires promising new chemical entities and repurposed compounds that address unmet medical needs and tests them in clinical trials that leverage crowdsourcing methods, advances in telemedicine and full data transparency. The company expects this innovative approach to result in significantly reduced costs and improved data quality. For more information, visit: www.transparencyls.com.
Contacts: | |
Corporate: | Media: |
Transparency Life Sciences: | BLL Partners, LLC |
Marc Foster | Barbara Lindheim |
COO | 212 584-2276 |
SOURCE Transparency Life Sciences, LLC
