Trading update and outlook for 2022
Trading update and outlook for 2022
Brighton, United Kingdom, 17 January 2022 – Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life threatening infections, announces today an update on the considerable progress being made with its late-stage clinical assets, its earlier research programmes and the exciting prospects for the year ahead.
· NTCD-M3 for prevention of CDI recurrence: Phase 3 trial preparation progressing well
· Good progress in licensing discussions for NTCD-M3
· XF-73 nasal gel for prevention of post-surgical infections: Regulatory discussions with EMA and FDA on Phase 3 clinical trials expected to conclude in H1 2022
· Preclinical work on SPOR-COV, designed to prevent coronavirus infections, progressing as planned
NTCD-M3: Potential breakthrough product for the prevention of recurrence of C. difficile infections (CDI)
NTCD-M3 is the world’s first, single strain, live biotherapeutic product being developed to reduce the recurrence of CDI in the gut which is targeted to start Phase 3 trials by the end of 2022. Good progress was made in 2021 with the transfer and commencement of the manufacturing scale up process for NTCD-M3. This is a key project requirement and needs to be delivered to a high standard at high volumes. Destiny Pharma’s clinical team is also finalising the detail of the Phase 3 clinical trial design and expects to conclude discussions with US and European regulators during the first half of 2022. Additionally, supportive microbiological research studies using NTCD-M3 are also underway, and results will be announced in the first quarter of 2022.
A number of competitor CDI projects delivered clinical trial results in 2021 including companies using faecal matter, bacterial consortia and antibiotic approaches. The results and data reported were encouraging for our Company and we remain confident in the superior profile and potential positioning of NTCD-M3 as a targeted, safe, effective and easy to use biotherapeutic preventive treatment. NTCD-M3 has delivered excellent clinical data from previously reported Phase 2 studies showing that it significantly reduces the levels of recurrence in CDI patients. Destiny Pharma remains very positive that when the planned Phase 3 trials deliver similar results that NTCD-M3 can become a breakthrough product to prevent the recurrence of CDI. This is a substantial commercial opportunity that the Company estimates could lead to peak sales of up to US$500 million in the US alone.
Destiny Pharma is making good progress in discussions with potential licensing partners for NTCD-M3, with several potential partners active in the data room. This is in line with the company’s stated strategy of seeking partners to help co-fund the required Phase 3 trials and lead the commercialisation.
XF-73: nasal gel for the prevention of post-surgical infections caused by Staphylococcal aureus
Following the excellent Phase 2 clinical results announced in H1 2021 the Company has advanced discussions with regulatory authorities in Europe and the US. These important discussions will help clarify the design, size and cost of the final Phase 3 clinical trials needed prior to registration. It is likely that feedback from EMA (European Medicines Authority) will be received before the US FDA (Food and Drug Administration). Destiny Pharma expects to receive feedback from the EMA during Q1 2022 and the FDA during Q2 2022 and is confident that getting clarity on the final Phase 3 studies will help secure partnering agreements.
Destiny Pharma is also carrying out a XF-73 nasal gel European market research project to update the understanding of the requirements of infectious disease physicians and payers in key European markets with regards to nasal decolonisation. Based on the key fundamentals of clinical need, efficacy, ease of use and value for money, Destiny Pharma is very confident there is a good European commercial opportunity in addition to the large US market for XF-73 nasal gel. Destiny Pharma estimates that global peak sales for XF-73 nasal gel could exceed US$1 billion with the US being half of the total market opportunity.
Earlier stage research projects
Good progress has been made with our joint partner SporeGen Limited in carrying out the pre-clinical work on SPOR-COV, the novel bacterial formulation designed to prevent coronavirus and other viral respiratory infections (including COVID-19 and influenza) by stimulating the innate immune system using a simple nasal spray. The work is largely funded by an £800,000 Innovate UK grant. SPOR-COV is being tested in COVID-19 and influenza infection models and the project is due to complete in Q1 2022. Plans for the next stage of development are being progressed to maintain momentum in the project after the grant funded work is completed.
Destiny Pharma has two active dermal infection research programmes using new XF-73 formulations that are continuing in 2022 and additional grant funded university collaborations researching new opportunities for the XF platform.
The Company also has several XF platform research projects that are progressing well and are largely funded by grants and non-dilutive funding.
Neil Clark, Chief Executive Officer of Destiny Pharma, said: “Destiny Pharma starts 2022 with a diversified and valuable drug pipeline targeted at infection prevention. We have strong belief in the clinical need for our leading assets and their global commercial potential. We are now focused on the finalisation of the Phase 3 trial plans for our two, differentiated, late-stage clinical assets and closing partnering deals. The Board and staff at Destiny Pharma are committed to delivering our strategy and we are excited about the year ahead.”