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Despite the recent and widespread adoption of CFTR modulator therapy, cystic fibrosis patients need additional options to manage their respiratory infections. Indeed, counterintuitively, the adoption of CFTR therapy is expected to expand – not dimmish – the pool of moderate-to-severe CF patients who would benefit most from ColiFin®. In Europe, patients have four approved inhaled therapies for these patients (tobramycin, aztreonam, levofloxacin and colistin) but the US FDA has only approved the first two of these for US patients. To give US patients expanded treatment options, EnBiotix has in-licensed ColiFin® (inhaled colistimethate sodium) from PARI Pharma GmbH, a global leader in nebulized therapies, for worldwide rights ex-Europe. Approved in Europe since 2010 as a front-line therapy for lung infections in CF, ColiFin® has a proven safety and efficacy track record. In addition, EnBiotix has received FDA approval to proceed with a single P3 trial as a basis to register for approval.

ColiFin® would:

  • Rapidly become a front-line treatment for CF infections in the U.S.
  • Improve outcomes for patients who can no longer tolerate or have infections resistant to tobramycin/aztreonam
  • Give patients who currently are receiving unapproved, i.v. formulated colistin in generic inhalers a safer, standardized and more easily reimbursed option

Bridging ColiFin® EU Approval to US CF Standard-of-Care: