Destiny Pharma highlights new ‘landmark’ NTCD-M3 data
(DEST ) says world leading scientists will present landmark data generated from a recent C. difficile infection (CDI) model study at the US Anaerobe 2022 Conference.
The objective of the model study was to investigate the ability of non-toxigenic C. difficile strain M3 (NTCD-M3) to successfully colonise the gut following administration of antibiotics.
Clostridium difficile, also called C. diff, is a type of bacteria that can cause a bowel infection.
Most recent data from a Phase 2 clinical trial in patients suffering CDI had demonstrated that the administration of
NTCD-M3 shortly after the use of antibiotics to treat the initial infection was able to successfully reduce recurrence from 30% in placebo to 5% in treated patients.
As part of the trial, patients received either vancomycin or metronidazole to treat the initial toxic C. difficile infection before receiving NTCD-M3 treatment. Since the end of this trial, a new antibiotic, fidaxomicin, has been added to US clinical guidelines for treating CDI.
It is already known that fidaxomicin resides for a longer period within the gut potentially inhibiting colonisation by bacteria such as NTCD-M3, the company explained to investors.
This latest study, which was conducted by the Microbiology Research Laboratory at the Edward Hines, Jr. VA Hospital in the US, sought to address this question by monitoring the colonisation of NTCD-M3 in an established CDI model following administration of fidaxomicin.
Destiny said the study demonstrated that NTCD-M3 was able to effectively colonise the gut following fidaxomicin administration indicating that NTCD-M3 would be effective in patients receiving this antibiotic as well as older antibiotics such as vancomycin and metronidazole.
The data generated from this recent model study has now been accepted for presentation at the prestigious Anaerobe 2022 Conference in Seattle, WA, US on Saturday, 30th July 2022.
Commenting on this recent model study, Dr Bill Love, Chief Scientific Officer of Destiny Pharma, said: “The relevance and impact of this study cannot be underestimated as it indicates that the clinical use of fidaxomicin to treat CDI is unlikely to affect the ability of Destiny’s late-stage asset, NTCD-M3, to colonise the gut and prevent recurrence of CDI.
“This is important as fidaxomicin has recently been added to the recommended guidelines for treatment of CDI in the US, and the use of this new antibiotic is growing,” he acknowledged.
Destiny said it is confident that its NTCD-M3 live biotherapeutics product can be used along all currently recommended antibiotics in the treatment of this serious hospital infection.
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According to analysts at the research firm, Equity Development, Destiny’s recently published 2021 financial results reflected the company’s prudent financial management over the year.
“Whilst preparing its two Phase 3-ready assets for partnering, the stumbles of its competitors in the CDI prevention space have made its negotiating position stronger and arguably, easier,” it said, with its valuation moving slightly from £210.3m or 289p per share to £209.6m or 288p.
Operating expenses excluding share-based payment charges decreased to £6m from £6.4m in FY20, largely as a result of the lower clinical trial expense after the XF-73 Phase 2b study.
These operating expenses included R&D costs of £3.7m, which came in under some analysts’ £3.8m estimate, and £2.3m in other operating costs (£4.5m and £1.9m in FY20, respectively).
Destiny has also manufactured scale-up processes for NTCD-M3 and initiated discussions with US and European regulators on finalising the details of the Phase 3 clinical trial design.
Regulatory discussions are now expected to conclude in 1H22 and the manufacturing scale up is expected to be completed by year-end, following which the Phase 3 trial will then begin.
In order to see the continued progression of NTCD-M3 and XF73, to finalise its regulatory plans and to strengthen its balance sheet, Destiny raised £6.5m following the period end.
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