Spexis AG (SIX:SPEX) is a publicly-listed Swiss clinical-stage biopharmaceutical company developing rare disease and oncology treatments in indications where new therapeutic options are urgently needed. Spexis AG was launched in December 2021 by the reverse merger of EnBiotix, Inc. (Boston, MA, USA) and Polyphor AG (Allschwil, Switzerland), with EnBiotix shareholders resulting in the majority. Our focus is on chronic respiratory diseases (CRD), and our lead product candidate ColiFin® is P3 ready.
ColiFin® is an inhaled colistimethate sodium product in-licensed from PARI Pharma GmbH for ex-European rights. Approved and marketed in Europe as a front-line therapy in cystic fibrosis (“CF”) patients, ColiFin® already has a proven safety, efficacy, and commercial track record. In the U.S., ColiFin® has Orphan Drug and Qualified Infectious Disease Product (“QIDP”) designations, which together will provide a total of 12 years of market exclusivity from NDA approval. We also have a “Study May Proceed” letter from the FDA regarding a single phase 3 study evaluating ColiFin® in CF patients being sufficient to support a future New Drug Application (“NDA”). The trial design has been endorsed by the Cystic Fibrosis Foundation (CFF) Therapeutic Development Network (TDN), the clinical development arm of the CFF. Of note, the CFF also invested in the pre-merger financing launching Spexis.
