PITTSBURGH, Sept. 16, 2020today announced the completion of enrollment in a Phase 2 trial of the oral small-molecule dexpramipexole in patients with moderate-to-severe eosinophilic asthma.
The multi-center Phase 2 trial is a randomized, double-blind, placebo-controlled study to evaluate the effects of three dose levels of oral dexpramipexole for 12 weeks. The primary endpoint is the change in peripheral blood eosinophil count. Secondary outcome measures include changes in pre-bronchodilator FEV1 and asthma control outcomes (ACQ-7 questionnaire) from baseline to week 12.
"We are pleased to complete enrollment in this Phase 2 trial and look forward to reporting top-line data early in 2021," said Michael Bozik, M.D., Chief Executive Officer of Knopp. "Knopp is committed to developing oral dexpramipexole as a targeted, eosinophil-depleting, pre-biologic treatment for patients with moderate-to-severe eosinophilic asthma. The benefit of eosinophil lowering as a therapeutic approach in asthma has been demonstrated by the success of injectable biologics in reducing asthma exacerbations, and dexpramipexole holds the potential to provide an effective oral alternative to these approved biologic treatments."
Eosinophils are white-blood cells that play a central role in a number of debilitating diseases, including asthma, hypereosinophilic syndrome.
More information on the Phase 2 asthma trial can be found under identifier NCT04046939 at clinicaltrials.gov.
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. Knopp's clinical-stage oral small molecule, dexpramipexole, is in Phase 2 clinical trials in moderate-to-severe eosinophilic asthma. Knopp's preclinical Kv7 platform is directed to small molecule treatments for developmental and epileptic encephalopathies, other rare epilepsies, neuropathic pain, and tinnitus. 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 pre-clinical or clinical study to verify their safety and effectiveness.
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