Destiny Pharma (DEST ) said a study has confirmed the potential of its therapeutic NTCD-M3 as a novel treatment to prevent the recurrence of Clostridioides difficile infections (CDI).
The biotechnology company which is focused on developing medicines that can prevent life threatening infections said the new study from the US Department of Veterans Affairs also indicates that NTCD-M3 can be used alongside all standard-of-care antibiotic treatments.
The research confirmed NTCD-M3's ability to colonise the gut after antibiotic administration. Destiny told investors that this confirmation strengthens the market opportunity of the therapeutic because it supports its use following commonly used antibiotic treatments.
The study was undertaken with the Edward Hines, Jr. VA Hospital in Illinois, which conducts advanced research into the diagnosis, epidemiology, prevention, and treatment of CDI.
In addition, Destiny has reported findings from North American and European market research which it said reinforce the clinical support and market potential of NTCD-M3.
Destiny explained that Clostridioides difficile occurs in the gut when oral antibiotics kill beneficial bacteria in the gut, causing unintentional and harmful collateral damage.
CDI, which releases toxins which cause disease, is the leading cause of hospital acquired infection in the United States, and current treatments can lead to significant recurrence.
In the United States, there are around 500,000 cases of CDI each year; many of these initial cases then recur leading to 29,000 deaths per year. It is estimated that CDIs result in an additional US$6 billion in healthcare costs per year in the US alone, Destiny told investors.
Destiny Pharma’s late‑stage asset NTCD-M3, which has already completed successful Phase 2 clinical trials, has been shown to prevent recurrence following the normal standard-of-care antibiotic treatment with only a 5% recurrence rate - the Company said it believes this is the biggest reported reduction in CDI recurrence from clinical studies.
Some antibiotics used for the treatment of CDI, including the existing treatment fidaxomicin (Dificid®), can remain in the gut for a prolonged period after treatment, potentially impacting the ability of the NTCD-M3 therapeutic to colonise and prevent infection recurrence.
The United States’ Department of Veterans Affairs conducted a preclinical study using the best accepted CDI research model whereby the study demonstrated successful (100%) gut colonisation of the NTCD-M3 therapeutic following treatment with fidaxomicin (Dificid®).
In addition, successful (100%) NTCD-M3 gut colonisation was also demonstrated following pre-treatment with vancomycin, the most commonly used first-line antibiotic treatment for CDI.
Destiny said the results provide further support and rationale for the use of NTCD-M3 as an adjunct to both current standard-of-care treatments for the prevention of CDI recurrence.
Commenting, Neil Clark, Chief Executive Officer of Destiny Pharma, said: “We are encouraged by these latest findings that support the administration of NTCD-M3 to the broadest CDI patient population receiving any approved antibiotic treatment and strengthens our planning for the NTCD-M3 Phase 3 study, which we aim to start later this year.”
Clark said, “The market research further supports these findings and will be invaluable in helping to position NTCD-M3 for the prevention of CDI, as well as development and commercial considerations critical to determining the product’s market potential.
“There is significant value potential in our NTCD-M3 asset, and we look forward to providing further updates on the regulatory and development plans throughout 2022,” he added.
North American and European market research has also been completed to understand the commercial implications of the clinical and market access landscape in CDI for NTCD-M3.
Interviews were conducted with High-Volume Prescribers (HVPs) and reimbursement experts across the US and Europe. Destiny said the findings provide “powerful external validation for Destiny Pharma’s product NTCD-M3 from clinicians and payers in both the US and Europe.”
Physicians said they were “very optimistic” about NTCD-M3's potential given the very low recurrence rate of 5% seen in the Phase 2 study, its mechanism of action, and safety profile.
The findings from the market research also confirmed that there is significant interest in using the product to prevent recurrence after a primary episode (a first infection) and first recurrence (those who have had a first infection and then subsequently a recurrence) patients, it noted.
A further finding from the market research also stated that by taking all the benefits together including cost and ease of use, the clinicians could see a “significant benefit” of NTCD-M3's approach over FMT (Faecal Microbiota Transplant) or bacterial consortia products.
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