PITTSBURGH--(BUSINESS WIRE)--Knopp Biosciences LLC today reported further clinical data from its Phase 2 Exhale trial demonstrating oral dexpramipexole improves airflow obstruction in asthma as measured by FEV1, largely through its effect on FVC. Change in FVC was the dominant contributor to increases in FEV1, which suggests that by lowering eosinophils in the airway lumen, dexpramipexole may act to decrease mucus plugging and air trapping in small airways. As previously reported, dexpramipexole produced clinically meaningful increases in FEV1 across study arms and time points.
The data were presented over the weekend as a poster during the American Academy of Allergy Asthma & Immunology (AAAAI) meeting in Phoenix, AZ.
Eosinophils, a type of white blood cell, are a validated therapeutic target in asthma, as evidenced by the regulatory approval of multiple eosinophil-lowering biologics. Treatments approved to date for eosinophilic asthma are monoclonal antibodies requiring injection or infusion; dexpramipexole is administered orally.
“These results provide new insight into the effects of eosinophils on pulmonary physiology, and further strengthen the hypothesis that reductions in blood and tissue eosinophils by dexpramipexole are associated with improved lung health,” said Calman Prussin, M.D., Chief Medical Officer of Knopp.
As previously reported, dexpramipexole was well tolerated in the EXHALE trial, with 97% of dexpramipexole-treated patients completing the primary assessment phase. There were no serious adverse events and no adverse events leading to discontinuation.
“We are excited to be rapidly moving into Phase 3 clinical development, with the goal of securing regulatory approvals from health authorities around the world, and provide a first-in-class oral therapeutic option for millions of eosinophilic patients,” said Michael Bozik, M.D., CEO of Knopp.
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 with high unmet need. Knopp’s clinical-stage oral small molecule, dexpramipexole, is in development for moderate-to-severe eosinophilic asthma. Knopp’s preclinical Kv7 platform is directed to small-molecule treatments for developmental and epileptic encephalopathies, other epilepsies, neuropathic pain, and smooth-muscle disorders. Please visit www.knoppbio.com.
Dexpramipexole, a selective inhibitor of eosinophil maturation, is an oral small molecule drug in development by Knopp for asthma and other eosinophil-associated diseases. In hypereosinophilic syndrome, dexpramipexole has previously been shown in a Phase 2 trial to significantly reduce requirements for oral corticosteroids and in a subset of patients to produce durable disease remission. In its earlier development in amyotrophic lateral sclerosis, dexpramipexole was shown to be well tolerated in Phase 1, Phase 2, and Phase 3 trials comprising approximately 1,200 patients.
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.