PITTSBURGH--(BUSINESS WIRE)--Knopp Biosciences LLC and the University of Leicester today announced 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 52-week, randomized, double-blind, placebo-controlled trial will evaluate whether dexpramipexole is associated with a reduction in asthma exacerbations. Fifteen severe asthma centers across the United Kingdom (UK) will be enrolling up to 100 total participants in the trial, led by the Leicester Clinical Trials Unit of the University of Leicester.
“We are pleased to collaborate with world-renowned asthma investigators in the UK to assess the effects of oral dexpramipexole on asthma exacerbations,” said Michael Bozik, M.D., president and CEO of Knopp. “An unmet need remains for an orally administered medicine for eosinophilic asthma, and we welcome the opportunity to assess dexpramipexole as an alternative to injectable biologic treatments.”
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 (NIHR) and Medical Research Council (MRC) 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 (FEV1), fractional exhaled nitric oxide (FeNO) 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 (HES) 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.
ABOUT KNOPP BIOSCIENCES LLC
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. Please visit www.knoppbio.com.
ABOUT THE UNIVERSITY OF LEICESTER
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. Find out more at https://le.ac.uk/about.
MRC AND NIHR
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.
1. The National Institute for Health Research (NIHR) is the nation's largest funder of health and care research. The NIHR:
- Funds, supports and delivers high quality research that benefits the NHS, public health and social care
- Engages and involves patients, carers and the public in order to improve the reach, quality and impact of research
- Attracts, trains and supports the best researchers to tackle the complex health and care challenges of the future
- Invests in world-class infrastructure and a skilled delivery workforce to translate discoveries into improved treatments and services
- Partners with other public funders, charities and industry to maximise the value of research to patients and the economy
The NIHR was established in 2006 to improve the health and wealth of the nation through research, and is funded by the Department of Health and Social Care. In addition to its national role, the NIHR commissions applied health research to benefit the poorest people in low- and middle-income countries, using Official Development Assistance funding.
2. The Medical Research Council (MRC) is at the forefront of scientific discovery to improve human health. Founded in 1913 to tackle tuberculosis, the MRC now invests taxpayers’ money in some of the best medical research in the world across every area of health. Thirty-three MRC-funded researchers have won Nobel prizes in a wide range of disciplines, and MRC scientists have been behind such diverse discoveries as vitamins, the structure of DNA and the link between smoking and cancer, as well as achievements such as pioneering the use of randomised controlled trials, the invention of MRI scanning, and the development of a group of antibodies used in the making of some of the most successful drugs ever developed. Today, MRC-funded scientists tackle some of the greatest health problems facing humanity in the 21st century, from the rising tide of chronic diseases associated with ageing to the threats posed by rapidly mutating micro-organisms. The Medical Research Council is part of UK Research and Innovation. https://mrc.ukri.org/
This press release contains "forward-looking statements," including statements relating to planned regulatory filings and clinical development programs. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including the uncertainties inherent in clinical trials and product development programs, the availability of funding to support continued research and studies, the availability or potential availability of alternative therapies or treatments, the availability of patent protection for the discoveries and strategic alliances, as well as additional factors that may cause Knopp's actual results to differ from our expectations. There can be no assurance that any investigational drug product will be successfully developed or manufactured or that final results of clinical studies will be supportive of regulatory approvals required to market a product. Knopp undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
Knopp's pipeline consists of investigational drug products that have not been approved by the U.S. Food and Drug Administration. These investigational drug products are still undergoing clinical study to verify their safety and effectiveness.