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The Concinnity Company, developer of smarter software for clinical trial oversight, partners with Neuren Pharmaceuticals (ASX: NEU) to provide next level clinical trial oversight management

NASHVILLE – February 10, 2022 – We are extremely happy to be Neuren’s partner in improving the lives of people with neurodevelopmental disabilities” said Nancy Falls, Concinnity Company CEO. Neuren Pharmaceuticals (ASX: NEU) is developing new therapies for highly debilitating neurodevelopmental disorders that emerge in early childhood. Currently there are no highly effective or disease-modifying drugs approved for these conditions. Because these are serious medical conditions with unmet need, speed, as well as quality, is of the essence.

In addition to seeking regulatory fast tracks, Neuren sought to ensure superior security and efficiency in its clinical trial oversight process. In search of the best software solution for managing these important clinical trial oversight committees, Neuren found The Concinnity Company and its Cloud Concinnity® platform.

“Concinnity is extraordinarily functional and comprehensive clinical trial oversight software: a single, secure platform where all meetings, documents and processes can be centralized, automated, monitored and generate a complete audit trail.” said James Shaw, Vice President, Clinical & Regulatory Operations. “By partnering with outstanding CROs and Concinnity, we can be assured of speed, security and efficiency in our oversight processes.”

Neuren’s use of Concinnity’s innovative software supports the Data Safety and Monitoring Committees’ oversight of 3 trials testing the safety, tolerability and pharmacokinetics of NNZ-2591 and measures of efficacy in children and adolescents with 3 syndromes: Pitt Hopkins Syndrome, Phelan-McDermid Syndrome and Angelman Syndrome. Implementation of the Cloud Concinnity platform is expected to reduce any administrative burdens so that the DSMC can complete its work securely, thoroughly and quickly by improving meeting coordination, document sharing and general workflow practices.

“The future of clinical research depends on the kind of improvements in information and communications access and control, process consistency and tracking and outcomes transparency that are only achievable with smart technology,” said Falls. “This is especially true trials for our most vulnerable patients, ones that involve complex or adaptive trial designs, tight monitoring of dosing escalation, the analysis of multiple and complex data streams, and rigorous regulatory involvement.”

About Concinnity:

Cloud Concinnity® is a cloud-based, integrated software platform that delivers facilitated information access, process control, and outcomes transparency for a higher level of efficiency, speed, and risk mitigation. Our focus is on oversight teams in the clinical trial arena, in particular Data Monitoring Committees (DMCs) and Data and Safety Monitoring Boards (DSMBs)/ Committees (DSMCs). Our roots are in meeting the exacting security and process needs of public corporate boards. Our founding team has deep experience in and around boards, special committees, healthcare and pharma, bringing industry, process and governance expertise to the platform.

About Neuren:

Neuren is developing two new drug therapies to treat multiple serious neurological disorders that emerge in early childhood. The lead drug compound, trofinetide, is currently in a Phase 3 clinical trial for Rett syndrome and has completed a Phase 2 clinical trial in Fragile X syndrome. Both programs have been granted Fast Track designation by the US Food and Drug Administration (FDA). Neuren has granted an exclusive licence to ACADIA Pharmaceuticals Inc. for the development and commercialisation of trofinetide in North America. Neuren plans to initiate Phase 2 trials for a second drug candidate, for each of PhelanMcDermid syndrome, Angelman syndrome and Pitt Hopkins syndrome in 2022. Because of the urgent unmet need, all five programs have been granted “orphan drug” designation in both the United States and the European Union.

Contact: Michael D’Amico The Concinnity Company [email protected] (615) 988-1501

Media Contact
Company Name: The Concinnity Company
Contact Person: Michael D’Amico
Phone: 01.615.397.6801
City: Nashville
State: TN
Country: United States
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