Knopp Biosciences Enters Collaboration with Leading UK Investigators to Commence Phase 2 Clinical Trial of Dexpramipexole in Severe Eosinophilic Asthma

Knopp Biosciences LLC, a privately held drug discovery and development company focused on delivering breakthrough treatments for inflammatory and neurological diseases with high unmet need, today announced a collaboration with a consortium of leading medical researchers in the United Kingdom to evaluate the ability of Knopp’s lead drug candidate, dexpramipexole, to reduce exacerbations in people with severe eosinophilic asthma.

The project is chiefly funded by the National Institute for Health Research (NIHR) and Medical Research Council (MRC) of the UK. The Chief Investigator for the Phase 2 multi-center, 52-week trial is Professor Salman Siddiqui, Professor of Airway Diseases at the University of Leicester and Consultant Respiratory Physician at Leicester’s Hospitals.

Dexpramipexole is an orally available small molecule 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 is advancing dexpramipexole into Phase 2 development in severe asthma and Phase 3 development in HES. Eosinophils are white-blood cells that play a central role in several debilitating conditions, including asthma, HES, and other inflammatory diseases.

In the Phase 2 UK trial, dexpramipexole 300 mg daily or placebo will be administered to 100 asthmatic patients with elevated eosinophil counts. The primary outcome measure is the annual rate of severe exacerbations. Secondary outcomes include the CompEx endpoint capturing asthma clinical deterioration, changes in lung function, and quality of life. The study will be conducted at approximately 12 clinical sites in the United Kingdom by a number of the world’s leading asthma investigators associated with the BEAT Severe Asthma Consortium. ‘

“Dexpramipexole is an oral tablet that lowers the number of eosinophils in the blood by stopping them from growing in the person’s bone marrow—the part of the body that produces new blood cells,” Professor Siddiqui noted. “We want to see if this treatment will be effective in reducing asthma attacks in patients with the T2-high subtype of severe asthma. This work has the potential to provide an alternative to oral steroids or biologic injections for this patient group.”

“We welcome this partnership with the University of Leicester and the BEAT Severe Asthma consortium to study the clinical utility of dexpramipexole on reducing exacerbations in patients with severe asthma and eosinophilia,” said Michael Bozik M.D., CEO of Knopp Biosciences. “In parallel with Knopp-sponsored trials, the UK study will significantly enrich our understanding of dexpramipexole’s potential role as an alternative to biologics in severe asthma.”

ABOUT KNOPP BIOSCIENCES LLC

Knopp Biosciences, based in Pittsburgh, PA, USA, is a privately held drug discovery and development company focused on delivering breakthrough treatments for inflammatory and neurological diseases with a high unmet need. Knopp’s clinical-stage small molecule, dexpramipexole, is entering Phase 2 clinical trials in eosinophilic asthma and Phase 3 development in hypereosinophilic syndrome. Knopp’s preclinical Kv7 platform is directed to small molecule treatments for neonatal epileptic encephalopathy, other rare epilepsies, tinnitus, and neuropathic pain. 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: https://le.ac.uk/about

ABOUT THE NATIONAL INSTITUTE FOR HEALTH RESEARCH

The National Institute for Health Research (NIHR) is the UK’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.

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.

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