Galapagos NV has announced that it has nominated a pre-clinical candidate potentiator for clinical development in its cystic fibrosis (CF) program.
Galapagos has developed multiple, novel potentiators that, in pre-clinical research, show high potency and superior efficacy in comparison to Kalydeco® (ivacaftor),the only approved disease-modifying CF drug on the market.
Furthermore, the Galapagos compounds show good drug-like properties, which support further pre-clinical development. The clean safety profile of these compounds should allow the combination with antibiotics frequently prescribed for CF patients.
From these series, Galapagos selected GLPG1837 as pre-clinical candidate and expects to start the first clinical trial before end 2014. Galapagos recently filed a patent application covering GLPG1837, with the expected patent life until at least 2034.
"Galapagos had several excellent compounds to choose from among its novel CF potentiators. GLPG1837 forms the first part of our strategy to develop novel and best-in-class therapies for CF. The Galapagos-AbbVie team is now fully ramped up to progress our correctors, which are needed in combination with the potentiator to address the unmet need of most CF patients," said Dr Piet Wigerinck, Chief Scientific Officer of Galapagos.
Galapagos initiated its research in CF in 2005 as part of a collaboration with the Cystic Fibrosis Foundation. In September 2013 Galapagos signed an agreement with AbbVie in which they will work collaboratively to develop and commercialize oral drugs that address the main mutations in CF patients, including F508del and G551D.
Under the terms of the agreement, AbbVie made an upfront payment of $45 million to Galapagos. Upon successful completion of pre-determined success milestones, AbbVie and Galapagos will share responsibility and funding for Phase III clinical development.
Galapagos is eligible to receive up to $360 million in total additional payments for developmental and regulatory milestones, sales milestones upon the achievement of minimum annual net sales thresholds and additional double-digit royalty payments on net sales.