The FDA has cleared the Investigational New Drug Application (IND) for lisinopril to be assessed as an adjunctive therapy for multiple sclerosis (MS), according to Transparency Life Sciences (TLS), a drug development company based on open innovation.
The clearance is the first for a clinical trial protocol developed with the aid of crowdsourcing, and is among the first to make intensive use of telemonitoring and other remote methods for patient data collection.
"FDA clearance of our first crowdsourced protocol is a major milestone in our efforts to build a drug development company for the twenty-first century," said Tomasz Sablinski, MD, PhD, founder and CEO of TLS. "In response to widespread recognition that the existing development model is unsustainable, TLS is pioneering a fresh approach that leverages advances in technology and communications. We look forward to working with the FDA and a growing community of contributors and partners to implement the lisinopril phase II trial, as we also assess additional development candidates encompassing both new chemical entities (NCEs) and repurposed compounds."
A key element of TLS's approach is incorporating insights gathered from a global crowd into its clinical protocols using the company's Internet-based Protocol Builder, an online tool that elicits input from patients, physicians and researchers to help design clinical trials more efficiently and with greater relevance to clinical practice and patients' needs.
"We spent much of this year refining our Protocol Builder tool and were able to use the responses we obtained from patients and healthcare experts to strengthen the lisinopril phase II protocol,” said Sablinski. “These included valuable insights on primary and secondary endpoints, inclusion/exclusion criteria and remote monitoring strategies. Going forward, we expect even more of the content of our protocols will be derived from curated crowd input."
A second TLS strategy is to dramatically reduce the cost and patient inconvenience of executing clinical trials by replacing patient site visits with telemonitoring and other measurements obtained from patients' homes. To achieve its goal of 50% or greater reduction in the cost of clinical trials, TLS is partnering with Advanced Monitored Caregiving (AMC Health), a comprehensive telehealth provider offering an array of easy-to-use in-home telemonitoring solutions. In the proposed 12-month lisinopril study, patients will visit in-person with clinical trial staff at the start and end of the trial, and all other study data will be collected at home.
"Based on our 10 years of successful operations, we know first-hand how effective at-home patient monitoring can be, providing significantly improved care at a much lower cost, said John Holland, senior vice president for research and business development, AMC Health. “FDA clearance of this lisinopril protocol, which primarily relies on telemonitoring-based patient assessments, is an encouraging breakthrough, and we look forward to working with TLS to ensure the success of this patient-centric approach to clinical research."
TLS has posted the FDA-cleared lisinopril protocol on its website and welcomes further input from patients, clinicians and researchers on details of the design, especially concerning the telemonitoring and statistical analysis aspects of the plan. TLS is also seeking input to its Protocol Builders for low-dose naltrexone as a potential treatment for Crohn's disease, and the PPAR activator pioglitazone as a possible new therapy for Parkinson's disease. In addition, the company's Indication Finder offers the opportunity to consider promising new indications for existing drug candidates.