Browsed by
Tag: Phase

Xenon Pharmaceuticals Receives FDA Feedback and is on Track to Initiate XEN496 Phase 3 Clinical …

Xenon Pharmaceuticals Receives FDA Feedback and is on Track to Initiate XEN496 Phase 3 Clinical …

BURNABY, British Columbia, Oct. 08, 2020 (GLOBE NEWSWIRE) — Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today provided regulatory updates on its proprietary pediatric neurology program, XEN496, a Kv7 potassium channel modulator that is a proprietary pediatric formulation of the active ingredient ezogabine being developed for the treatment of KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE). With the U.S. Food and Drug Administration (FDA) having completed its review of the clinical trial protocol, Xenon is on track to initiate the XEN496 Phase 3 clinical trial in pediatric patients with KCNQ2-DEE before year-end.

In addition, Xenon has received a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA), which recommends the granting of an orphan medicinal product designation for XEN496 for the treatment of KCNQ2-DEE. This European designation is in addition to the FDA granting Fast Track designation for XEN496 for the treatment of seizures associated with KCNQ2-DEE as well as Orphan Drug Designation (ODD) for the treatment of KCNQ2-DEE.

Dr. Simon Pimstone, Xenon’s Chief Executive Officer, said, “This marks an extremely important milestone for Xenon, with the first of our proprietary product candidates now poised to enter a pivotal Phase 3 clinical trial. With feedback from the FDA, pharmacokinetic data supportive of our proprietary pediatric formulation, and considerable progress made in site selection and other preparations, we are excited to move forward with our ‘EPIK’ Phase 3 clinical trial studying XEN496 in pediatric patients with KCNQ2-DEE. In addition, receiving an orphan medicinal product designation for XEN496 in Europe underscores that KCNQ2-DEE is a severe, early onset epilepsy disorder and further validates Xenon’s novel, ‘precision medicine’ approach to develop treatments for pediatric epilepsies. We continue to work closely with the medical community, genetic testing companies, and patient advocacy groups to identify potential patients for

Read the rest
Corbus Pharmaceuticals Announces Phase 2b Study of Lenabasum for Treatment of Cystic Fibrosis …

Corbus Pharmaceuticals Announces Phase 2b Study of Lenabasum for Treatment of Cystic Fibrosis …

  • Study did not meet primary endpoint of reducing rate of pulmonary exacerbations
  • Lenabasum treatment had a favorable safety profile and was well-tolerated
  • Data to be presented at the upcoming North American Cystic Fibrosis Conference Oct. 7-23

Norwood, MA, Oct. 06, 2020 (GLOBE NEWSWIRE) — Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical-stage drug development company pioneering transformative medicines that target the endocannabinoid system, today announced topline results from its 28-week Phase 2b study of lenabasum in patients with cystic fibrosis (CF). The study enrolled patients in the U.S., Canada and Europe at high risk for recurrent pulmonary exacerbations (PEx). Subjects received lenabasum or placebo added to their background treatments for CF.

The CF-002 Phase 2b trial did not meet the primary endpoint of a statistically significant reduction in rate of new PEx per subject per 28 weeks. Lenabasum treatment had a favorable safety profile and was well-tolerated.

The topline data will be presented at the upcoming virtual North American Cystic Fibrosis Conference (NACFC), taking place October 7-23, 2020.

Barbara White, M.D., Chief Medical Officer and Head of Research of Corbus, said, “We are very disappointed that the study did not meet the primary endpoint. We look forward to providing more details of study results starting tomorrow at NACFC. We thank the participants, the staff at study sites, the Cystic Fibrosis Foundation, and the European Cystic Fibrosis Society Clinical Trials for their support and partnership throughout this study.”

Yuval Cohen, Ph.D., Chief Executive Officer of Corbus, said, “We are immensely grateful to the Cystic Fibrosis Foundation for their invaluable support of this program from its inception. It has been a privilege to work with the CF community throughout this development program.”

Phase 2b CF-002 Trial Design

CF-002 was a multinational Phase 2b study evaluating the efficacy and

Read the rest