Neil Clark & Shaun Claydon of Destiny Pharma discusses their 2021 highlights & what's expected in 2022
Neil Clark, CEO & Shaun Claydon, CFO of Destiny Pharma #DEST discuss their 2021 highlights including the progress of their two, late-stage clinical assets targeted at infection prevention, both of which are backed by strong Phase 2 clinical data and they also outline what’s expected in 2022.
NTCD-M3 for prevention of C. difficile infection recurrence
· Good progress made during the year with the transfer and commencement of manufacturing scale up processes and advancement of discussions with US and European regulators on finalising the detail of the Phase 3 clinical trial design. Regulatory discussions are expected to conclude in the first half of 2022, manufacturing scale up by year-end and the Phase 3 trial is targeted to commence thereafter.
· Discussions are progressing with potential licencing partners, with several parties active in the data room. This is in line with the Company's strategy of seeking partners to co-fund Phase 3 trials and lead commercialisation of the asset.
· US Department of Veterans Affairs research study confirms the potential of NTCD-M3 as a novel treatment to prevent the recurrence of C. difficile infections (CDI) that can be used alongside all standard-of-care antibiotic treatments.
· US and European market research underpins clinical support and market potential of NTCD-M3.
· Establishment of a NTCD-M3 clinical advisory board consisting of Professor Dale Gerding MD, US, who discovered NTCD-M3, Professor Mark Wilcox MD, 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.
XF-73 nasal gel for prevention of post-surgical infections
· Positive top-line results in Phase 2b clinical study reported in 2021. Primary efficacy endpoint met successfully with high statistical significance and no treatment related safety events.
· Very good secondary endpoint data announced in August 2021 showed that XF-73 has the potential to keep patients at a significantly low S. aureus nasal burden during the period of highest infection risk which runs from 1 hour prior to incision, during surgery itself, to the start of wound healing and out to 6 days post-surgery.
· Independent European report underpins the clinical need and market opportunity of XF-73 nasal gel which is seen as a very promising alternative to the current standard of care, Mupirocin, by both clinicians and payers.
· Successful XF-73 nasal gel Phase 2b study data was presented at 2021 ECCMID (European Congress of Clinical Microbiology & Infectious Diseases) Congress by infection prevention expert, Professor Julie Mangino MD.
Earlier pipeline and research projects
· Two new collaborations signed: NIAID in US supporting XF-73 dermal infection programme and US Department of Veterans Affairs to research NTCD-M3 for prevention of recurrence of CDI.
· Pre-clinical work on SporCov COVID-19 programme in collaboration with joint partner SporGen Limited (which is largely funded by an £0.8 million Innovate UK grant) completing in H1 2022. Plans for next stage of development are being progressed.
· XF platform research projects are progressing well after Covid-19 delays and are largely funded by grants and non-dilutive funding.
Post period highlights
· Positive feedback received from the European Medicines Agency (EMA) on plans for XF-73 nasal gel Phase 3 programme design. Phase 3 can use a similar primary endpoint to the successful Phase 2b clinical study, providing a route through Phase 3 trials to the European approval of XF-73 nasal gel as a ground breaking hospital infection prevention product. Feedback from FDA is expected in Q2 2022.
· Successful completion of the first of two pre-clinical safety studies of XF-73 Dermal formulation. Work continues with US Government's NIAID to complete preclinical safety package that will support future clinical development of XF-73 Dermal in serious wound infections.
· China Medical System Holdings Limited (CMS), the Company's China regional partner and investor, started an additional dermal programme with XF-73 targeting the prevention and treatment of superficial skin infections caused by bacteria.
· Successful equity fund raise of £6.5 million (gross) to enable continued progress of NTCD-M3 and XF73 nasal toward Phase 3 clinical studies, finalisation of regulatory plans and strengthening of balance sheet.
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