Destiny Pharma says its two lead assets have ‘clear commercial positioning’
(DEST ) told investors that it has made “excellent progress” in developing its pipeline throughout the year to 31 December 2021 with the company’s two late-stage clinical assets now backed up by strong Phase 2 clinical data and “clear commercial positioning.”
The clinical stage biotechnology company is currently focused on the development of NTCD-M3, its Phase 3 ready treatment for the prevention of C. difficile infection recurrence, and the XF-73 nasal gel, which has recently completed a positive Phase 2b clinical trial targeting the prevention of post-surgical staphylococcal hospital infections including MRSA.
Destiny has already 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.
Destiny said discussions are progressing well with potential licensing partners engaged as the company seeks partners to co-fund Phase 3 trials and lead commercialisation of the asset.
While a study by the US Department of Veterans Affairs research has confirmed the potential of NTCD-M3 as a novel treatment to prevent the recurrence of C. difficile infections, US and European market research also underpins the asset’s clinical support and market potential.
Meanwhile, Destiny reported positive top-line results over the period for its Phase 2b clinical study of the company’s XF-73 nasal gel. During the study, the primary efficacy endpoint was met successfully with high statistical significance and no treatment related safety events.
Secondary endpoint data 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. The Company is now awaiting feedback from the US FDA which is expected in 2Q22.
The company further highlighted that an independent European report has also underpinned 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 clinicians and payers.
Since the period-end, Destiny has received positive feedback from the European Medicines Agency (EMA) on plans for XF-73 nasal gel Phase 3 programme design. It explained this can use a similar primary endpoint to the successful Phase 2b study, providing a route through Phase 3 trials to the European approval of XF-73 as a hospital infection prevention product.
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.
In FY21, the Company reported a loss before tax of £6.3m, down slightly from £6.5m in FY20. Year-end cash and cash equivalents stood at £4.6m, compared to £9.7m in 2020, excluding the post period equity fund raise of £6.5m which has extended its cash runway to mid-2023.
CEO of Destiny, Neil Clark commented: “With full control of two high quality, late-stage clinical assets targeted at infection prevention, both of which are backed by strong Phase 2 clinical data and clear commercial positioning, Destiny Pharma is very well positioned for the future.”
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