Destiny Pharma (DEST ) said it is making ‘positive progress’ with NTCD-M3, a microbiome therapeutic being developed to reduce the recurrence of C. difficile infections in the gut.
C. difficile, or CDI, which is a type of bacteria that can cause a bowel infection, is the leading cause of hospital acquired infection in the US and current treatments lead to significant recurrence. In the United States alone, there are approximately 500,000 cases of CDI each year; with many of these initial cases then recurring, leading to 29,000 deaths per year.
Destiny said its lead clinical programme for the therapeutic, NTCD-M3, has the potential to become the leading treatment for CDI, as it appears to deliver clear advantages to both existing CDI treatment options and also to those currently in clinical development, it said.
According to data from Destiny, the benefits of NTCD-M3 is that it is a naturally occurring, single strain of a non-toxigenic bacteria with demonstrated good safety and strong clinical data. In a previous phase 2 trial, the CDI recurrence rate out of the trial’s group of NTCD-M3 treated patients was only 5% which Destiny has described as a “class leading” statistic.
NTCD-M3, dubbed a ‘convenient treatment’, can be taken alongside all current standard of care antibiotic treatments as a single capsule taken once daily for seven days. In addition, the Group said it intends to manufacture the therapeutic at ‘high volume and low cost with a long shelf life’ which should enable high uptake and a strong pharmacoeconomic position.
Destiny Pharma said it is currently progressing the planning for the single Phase 3 clinical study that needs to be completed before submitting marketing authorisation applications in the US and Europe. The Phase 3 clinical study remains on schedule to commence in 2022.
Shares in Destiny Pharma have more than doubled in value since the beginning of 2021. The stock was trading 7.51% higher this morning at 157.5p following the announcement.
In this morning’s update, the Group told investors that it has already completed several development and manufacturing activities which forms part of the production process.
To date, Destiny has completed the technology transfer to a drug manufacturing organisation (CDMO) that will produce NTCD-M3 and it has set-up ‘key analytical viability methods’ that will be used to assess the quality and purity of the spores of NTCD-M3.
Development work on fermentation to achieve ‘high and reproducible’ NTCD-M3 concentrations has been initiated while preliminary work is also underway to define a matrix and method of drying to formulate NTCD-M3 into an easy-to-use, stable, oral capsule.
To date, Destiny’s clinical trial planning is ‘progressing well’ with activities already underway, it said. The Group has established a clinical advisory board for NTCD-M3 and initiated the supplier selection of a clinical trial organisation (CRO) for the Phase 3 study.
The Company informed investors that it has already commenced discussions with potential licensing partners and collaborators, adding that it is encouraged by the level of interest in the programme so far. The aim of these discussions is 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 £10.4 million equity funding in December 2020 that enabled the NTCD-M3 acquisition,” said CEO, Neil Clark.
He added, “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."
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