SBIR-STTR Award

Direct to Phase II

The goal of this Direct to Phase II program is to develop and test the efficacy of a Precision Medicine Clinical Trials Enrollment Platform for kidney diseases. Approximately half of randomized controlled trials do not meet their recruiting target. Enrolling trials targeting rare kidney diseases is particularly challenging with many conditions subject to stratification and sub-typing, largely based on histopathological analysis. Due to Arkana's position as the largest nephropathology practice in the U.S., drug developers often approach the company to assist in identifying patients with clinical indications of interest. Focusing recruitment on esoteric nephropathology is a unique and innovative approach to clinical trials enrollment, which is likely to have significant value to sponsors. Arkana is therefore in a one-of-a-kind position to support pathology-directed enrollment, with 25+ world-class renal pathologists and access to a large patient population required to form statistically valid cohorts, even for rare conditions. Arkana has already developed Arkana Connect™, a mobile app allowing clinicians to track the processing of patient biopsies and retrieve pathology reports. During a Phase I-equivalent program, the company initiated the development of key infrastructure to support pathology reporting and clinician communication on the app. Over 1,300 clinicians use the app routinely, providing a straightforward pathway for market entry of the updated enrollment app capabilities. The company has also benchmarked enrollment efficiency for multiple rare kidney diseases based on prior clinical trial enrollment projects undertaken with manual methods; we expect to at least double enrollments through development of technology that improves patient selection and the communication of trial availability with clinicians. Based on the success of Arkana Connect™, the company is eager to move forward with development and validation of enrollment functions, as well as field testing to evaluate: 1) improved enrollment efficiency using the app for rare kidney diseases; and 2) improve access to clinical trials in traditionally underserved communities including urban, exurban, and rural areas. During Phase II we will focus on optimizing the digital infrastructure of the app to ensure reliable communication and compliance with regulations regarding patient privacy. Discrete element search functions will be developed, allowing clinical trial sponsors to target narrowly defined patient populations, essential for development of therapeutics against rare diseases. Validation studies will be undertaken to finalize the commercial version of the app and a subsequent study representing 400 participating physicians will be performed to evaluate the ability of this new technology and process to improve clinical trial enrollment. Data from these evaluations will provide compelling evidence to Arkana's customers, the sponsors of kidney disease clinical trials, that pathology-directed patient recruitment aided by technology can address the unmet need for efficient and targeted clinical trial enrollment.

Public Health Relevance Statement:
Narrative Enrolling clinical trials relies on a range of manual processes and requires timely communication with clinicians to avoid losing patients to follow-up. Arkana Laboratories has developed a mobile app, Arkana Connect™ which provides nephrologists with pathology reports, replacing antiquated manual reporting systems like fax machines. The company now proposes a Direct to Phase II SBIR program to develop automated clinical trial enrollment feature on the Arkana Connect App to provide trial sponsors with a more automated, efficient, and timely means of enrolling trials for kidney disease research. Terms: