PITTSBURGH-(BUSINESS WIRE)-Knopp Biosciences LLC kondigde vandaag het begin aan van de Fase 2 dosis-ranging klinische studie in milde-tot-ernstige eosinofiele astma. De rekrutering in de proef is aan de gang en de eerste patiënt is ingeschreven. Het bedrijf verwacht in de tweede helft van 2020 top-line gegevens van deze studie te rapporteren.
Deze 12 weken durende biomarkerstudie is gepland om ongeveer 100 patiënten met eosinofiele astma te randomiseren om de eosinofiele respons op drie verschillende doses orale dexpramipexole te onderzoeken. De primaire uitkomstmaatstaf van deze gerandomiseerde, dubbelblinde, placebo-gecontroleerde studie is de verandering in het absolute aantal eosinofiele bloedcellen van Baseline naar Week 12.
Knopp Biosciences Announces Start of Phase 2 Clinical Trial Evaluating Oral Dexpramipexole in Moderate-to-Severe Eosinophilic Asthma
PITTSBURGH–(BUSINESS WIRE)– Knopp Biosciences LLC today announced the start of Phase 2 dose-ranging clinical trial in moderate-to-severe eosinophilic asthma. Recruitment in the trial is underway and the first patient has been enrolled. The Company anticipates reporting top-line data from this trial in the second half of 2020.
This 12-week biomarker study is planned to randomize approximately 100 patients with eosinophilic asthma to investigate the eosinophil response to three different doses of oral dexpramipexole. The primary outcome measure of this randomized, double-blind, placebo-controlled study is the change in blood absolute eosinophil count from Baseline to Week 12. The secondary outcome measures include changes in pre-bronchodilator FEV1 and asthma control outcomes (ACQ-7 questionnaire) from baseline to week 12.
“We estimate that there are more than two million moderate-to-severe eosinophilic asthma patients in the U.S. and are excited about further characterizing the clinical profile of oral dexpramipexole in this difficult-to-control disease,” said Michael E. Bozik, M.D., President and CEO of Knopp Biosciences.
Eosinophils are white-blood cells that play a central role in a number of debilitating diseases, including asthma, hypereosinophilic syndrome (HES), eosinophilic gastroenteritis, and atopic dermatitis. Knopp has previously reported the highly significant eosinophil-lowering effects of oral dexpramipexole including positive Phase 2 clinical trial results in HES.
ABOUT KNOPP BIOSCIENCES LLC
Knopp Biosciences is a privately held drug discovery and development company focused on delivering breakthrough treatments for inflammatory and neurological diseases of high unmet need. In addition to developing oral dexpramipexole for eosinophil associated diseases, Knopp’s preclinical Kv7 platform is directed to small molecule treatments for KCNQ2 epileptic encephalopathy and other CNS hyperexcitability disorders. Please visit www.knoppbio.com
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.