3 December 2019 - - US-based drug discovery and development company Knopp Biosciences LLC and the University of Leicester has released timelines, trial details, and eligibility criteria for a planned Phase 2 clinical trial evaluating the oral eosinophil-lowering drug candidate dexpramipexole in severe eosinophilic asthma patients that is on track to begin in the first half of 2020, the organisations said.

The 52-week, randomised, double-blind, placebo-controlled trial will evaluate whether dexpramipexole is associated with a reduction in asthma exacerbations.

Fifteen severe asthma centres across the United Kingdom will be enrolling up to 100 total participants in the trial, led by the Leicester Clinical Trials Unit of the University of Leicester.

Salman Siddiqui, M.D., Ph.D., Professor of Airway Diseases at the University of Leicester and Consultant Respiratory Physician at Leicester's Hospitals, will serve as the Chief Investigator for the study.

The clinical program is chiefly funded by the National Institute for Health Research and Medical Research Council of the UK, with the drug candidate, matching placebo, and additional support provided by Knopp Biosciences.

The primary outcome measure is the annual rate of asthma exacerbations. Secondary outcomes include changes from baseline in Asthma Control Score (ACQ-6), lung function, fractional exhaled nitric oxide levels, and a number of quality-of-life-related measures.

Eligibility criteria include a history of exacerbation-prone asthma and elevated blood eosinophils (≥0.30 x109/L cells).

Patients who have failed monoclonal antibody therapy are eligible to participate in the trial after a period of biologic washout (5 months).

Dexpramipexole is an orally available small molecule drug candidate shown to selectively reduce eosinophil levels in multiple clinical trials, including in a Phase 2 study in hypereosinophilic syndrome and a Phase 2 trial in chronic rhinosinusitis with nasal polyps.

Knopp has separately initiated a Phase 2 dose-ranging biomarker trial in the United States of oral dexpramipexole in moderate-to-severe eosinophilic asthma.

Eosinophils are white-blood cells that play a central role in several debilitating conditions, including asthma, HES, and other inflammatory diseases.

Knopp Biosciences is a privately held drug discovery and development company focused on delivering breakthrough treatments for immunological and neurological diseases of high unmet need.

In addition to developing oral dexpramipexole for eosinophil-associated diseases, Knopp directs its preclinical Kv7 platform to small molecule treatments for KCNQ2 epileptic encephalopathy and other CNS hyperexcitability disorders.

The University of Leicester is led by discovery and innovation an international centre for excellence renowned for research, teaching and broadening access to higher education.

It is among the top 25 universities in the Times Higher Education REF Research Power rankings with 75% of research adjudged to be internationally excellent with wide-ranging impacts on society, health, culture, and the environment.

The University is home to just over 20,000 students and approximately 3,000 staff.

The study was funded by an MRC and NIHR partnership created to support the evaluation of interventions with potential to make a step-change in the promotion of health, treatment of disease and improvement of rehabilitation or long-term care.