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

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

March 20, 2019 Off By BusinessWire

Lead investigator Prof. Salman Siddiqui sees potential to provide an
alternative to oral steroids or biologic injections for severe asthma
patients with high eosinophil counts

PITTSBURGH–(BUSINESS WIRE)–lt;a href=”https://twitter.com/hashtag/asthma?src=hash” target=”_blank”gt;#asthmalt;/agt;–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.”