Under a new agreement, Destiny Pharma and Sebela Pharmaceuticals will co-develop NTCD-M3, Destiny’s lead asset for the prevention of Clostridioides difficile infection (CDI) recurrence.
It is anticipated that Sebela will lead and finance the future clinical development and commercialisation activities of NTCD-M3 in North America.
Destiny will keep most rights for Europe and Rest of the World, while Sebela will have a minority interest in any income generated in these non-North American territories based on the clinical studies it is funding.
The agreement, which could be worth up to $570m to Destiny Pharma in milestones, includes an initial upfront payment of $1m, success-based development milestones of $19m, sales revenues-based milestone payments up to $550m, and tiered, double-digit royalties.
Destiny Pharma is obliged to continue its current plan to complete the ongoing manufacture of all clinical trial supplies needed to undertake the required clinical studies. It is anticipated that Phase III studies will commence in 2024.
NTCD-M3 was originally in-licensed in November 2020 and is a naturally occurring non-toxigenic strain of C difficile which lacks the genes that can express C difficile toxins. Patients who have taken NTCD-M3 were found to be protected from toxic strains of CDI.
NTCD-M3 acts as a safe ‘ground cover’, preventing toxic strains of C difficile proliferating in the colon after antibiotic treatment. NTCD-M3 temporarily colonises the human gut without causing any symptoms and the gut microbiome returns to normal a few weeks after treatment.
