Destiny Pharma reports positive progress on lead clinical programme

The AIM-traded firm said NTCD-M3 is a novel microbiome therapeutic being developed to reduce the recurrence of C. difficile infections (CDI) in the gut.

It said CDI is the leading cause of hospital-acquired infection in the United States, with current treatments leading to “significant” recurrence.

In the US, there are around 500,000 cases of CDI each year, with many of those initial cases then recurring, leading to 29,000 deaths annually.

Destiny said NTCD-M3 had the potential to become “the leading treatment” for CDI, as it appeared to deliver clear advantages to both existing treatment options and also to those currently in clinical development.

The company said the benefits of NTCD-M3 included the fact it is a naturally-occurring, single strain of a non-toxigenic bacteria, with “good” safety as a well-defined treatment.

It also pointed to “strong” clinical data, with a CDI recurrence rate for NTCD-M3-treated patients with the best dose in previous phase 2 trial of 5% described as “class leading”.

The treatment could be taken alongside all current standard-of-care antibiotic treatments as a single capsule taken once daily for seven days.

Destiny said it would be manufactured at high volume and a low cost, with a long shelf life, which would enable high uptake and a “strong” pharmacoeconomic position.

The treatment also had fast track designation from the US Food and Drug Administration (FDA).

Destiny Pharma said it was progressing the planning for the single phase 3 clinical study that needed to be completed before submitting marketing authorisation applications in the US and Europe, with the study on schedule to start in 2022.

Key development and manufacturing activities undertaken to date included completing the technology transfer of information into the new contract drug manufacturing organisation (CDMO) that would produce NTCD-M3 in its specialised biotherapeutic fermentation plant.

It had also completed the setup of key analytical viability methods that would be used to assess the quality and purity of the spores of NTCD-M3 produced in the manufacturing process.

Destiny said it had initiated process development work on fermentation to achieve a high-and reproducible NTCD-M3 concentration, with preliminary work also 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.

Clinical trial planning was also said to be progressing well, with the establishment of a NTCD-M3 clinical advisory board consisting of professor Dale Gerding, who discovered NTCD-M3, as well as professor Mark Wilcox, UK key opinion leader in CDI, and other medical and drug development experts with recent experience of running and designing international phase 3 clinical studies in CDI.

The company said it had initiated the supplier selection of a clinical trial organisation for the study as well.

Destiny said it had started discussions with potential licensing partners and collaborators, and was encouraged by the level of interest in the programme.

The aim was to secure a partner to help fund the planned phase 3 clinical study, and participate in the future commercial launch of NTCD-M3.

“We have made significant progress since closing the £10.4m equity funding in December that enabled the NTCD-M3 acquisition,” said chief executive officer Neil Clark.

“NTCD-M3 is a potential breakthrough in CDI treatment targeting a market that is forecast to grow to $1.7bn by 2026 and is 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.”

At 0959 BST, shares in Destiny Pharma were up 1.08% at 148.08p.