Destiny Pharma PLC making significant strides towards phase III evaluation of potential breakthrough C.diff treatment

  () chief executive Neil Clark said the group has made significant progress preparing its lead asset, NTCD-M3, for a phase III clinical study, which was on track to go ahead next year.

The microbiome therapeutic is being developed to reduce the recurrence of C.difficile infections () in the gut, the leading cause of hospital-acquired infection in the US.

In the update, Destiny said much of the work so far had focused on the production process. It has now completed the technology transfer to a new contract drug manufacturing organisation that will produce NTCD-M3.

It has also finished the “key” analytical viability methods that will be used to assess the quality and purity of the spores of NTCD-M3 created in the production process.

And it has initiated process development work on fermentation to achieve “high and reproducible” NTCD-M3 concentrations.

Preliminary work is underway to define a matrix and method of drying to isolate NTCD-M3 within a solid matrix for formulation as an easy-to-use, stable, oral capsule, investors were told.

Clinical trial planning, meanwhile, has seen the creation of a clinical advisory board that includes professors Dale Gerding, who discovered NTCD-M3 and Mark Wilcox, a key opinion leader in CDI.

Destiny said it has also begun the selection process to find a clinical research group to carry out the phase III study.

CEO Clark said: “We have made significant progress since closing the £10.4mln equity funding in December 2020 that enabled the NTCD-M3 acquisition.”

The drug is a potential breakthrough in CDI treatment targeting a market that is forecast to grow to $1.7bn by 2026. Clark described it as a “very valuable, late-stage asset”.

“We look forward to making further progress this year and to finalising the Phase 3 study design and manufacturing set up,” he added.