Biopharmaceutical company Spexis has announced a capital commitment totalling USD $2.5 million for funding of upcoming Phase 3 studies for its chronic cystic fibrosis infection treatment.
ColiFin is an inhaled therapeutic for the management of chronic infections in cystic fibrosis (CF) patients.
Although cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy has transformed the lives of CF patients, it has also expanded the need for ColiFin since the overwhelming majority of adult CF patients have irreversible lung damage causing them to suffer from chronic infections despite CFTR modulator therapy.
As CFTR modulator therapy will extend the lives of CF patients, the actual pool of CF patients needing a product like ColiFin will increase significantly over the next 20-30 years. Spexis in-licensed worldwide ex-European rights to ColiFin from PARI, a world-leader in nebulised drug delivery.
This will also allow for continued progress across start-up activities for COPA, the second part of our planned pivotal efficacy and safety Phase 3 study
- Jeff Wager, MD, Chairman & CEO of Spexis
Spexis achieved funding with participation from SPRIM Global Investments (SGI) and institutional investors to fund the upcoming Phase 3 ColiFin studies, beginning with the COPILOT study which is expected to initiate in the third quarter of 2023.
The $2.5 million capital commitment will be in the form of $1 million in secured, interest-bearing debt with partial warrant coverage from SGI and $1.5 million subordinated debt mandatorily converting into equity from institutional investors.
“This additional commitment from SPRIM demonstrates their continued support for the clinical development of ColiFin, our inhaled macrocycle therapeutic for the management of chronic infections in cystic fibrosis patients” said Jeff Wager, MD, Chairman & CEO of Spexis.
Wager continued: “This new capital allows us to not only initiate the COPILOT study in the third quarter, but will also allow for continued progress across start-up activities for COPA, the second part of our planned pivotal efficacy and safety Phase 3 study.”