Phase 2b study on track to complete recruitment in mid-2020 Earlier grant funded programs progressing to plan Company well-funded through to mid-2021
Brighton, United Kingdom – 3 March 2020 – Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel, hospital infection prevention treatments that address the global challenge of antimicrobial resistance (AMR), provides a clinical development and business update for the year ended 31 December 2019.
The Company’s ongoing Phase 2b clinical trial of its lead asset, XF-73 (exeporfinium chloride) nasal gel, is testing XF-73 as a novel drug for the prevention of post-surgical infections caused by Staphylococcus aureus (SA), including the superbug variant methicillin-resistant S. aureus (MRSA). US, EU and WHO surgical guidelines are recommending this type of treatment to tackle nasal SA/MRSA bacterial carriage in all high risk surgeries and the Company forecast peak US sales of $US 1 billion driven by the appropriate use of XF-73 in millions of eligible surgical procedures.
The Phase 2b trial remains on track to complete patient recruitment in mid-2020 despite slower than planned recruitment over the last three months. To date, Destiny Pharma has opened 15 of the targeted 23 hospital clinical trial sites in the US and Europe to enable the recruitment of 200 open-heart surgery patients as required under the Investigational New Drug Application opened in 2019. A total of 60 patients have so far been successfully recruited and enrolled in the study.
As previously reported, recruitment has been slower than planned in the US, but good progress was made in European sites in the second half of 2019. During Q4 2019, the European recruitment rate slowed due to a shortfall in eligible cardiac surgery procedures in one country. This was driven by changes in government hospital reimbursement for cardiac surgeries and had no connection with the XF-73 clinical trial protocol. The situation was resolved in January 2020 and patient screening and recruitment has returned to plan. Destiny Pharma is also opening further clinical sites and an additional European country to boost recruitment. As a result, the Company now expects to report an interim safety, efficacy and futility analysis, that will be conducted by an Independent Safety Monitoring Board, during Q2 2020. Full Phase 2b study data will be available after recruitment completes in mid-2020.
Destiny Pharma’s four grant funded programmes researching the potential of compounds from the XF drug platform in dermal, respiratory, ocular and biofilm related infections are progressing to plan and updates will be announced during 2020.
Destiny Pharma had an unaudited cash position of £7.5 million as at 31 December 2019, which will provide a cash runway through to H1 2021. Destiny Pharma expects to report its audited financial results for the year ended 31 December 2019 in April 2020.
About Destiny Pharma
Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development and commercialisation of novel medicines from its XF Platform that represent a new approach to the prevention and treatment of infectious disease. The company's lead programme is undergoing a Phase 2b clinical trial and is targeting the prevention of post-surgical hospital infections including MRSA. The XF drug candidates are being developed for the prevention and treatment of life-threatening infections caused by antibiotic-resistant bacteria, often referred to as "superbugs". Tackling antimicrobial resistance has become a global imperative recognised by the World Health Organisation (WHO) and the United Nations, as well as the G7 and the G20 countries. For further information, please visit https://www.destinypharma.com
XF-73 is a synthetic antimicrobial active against all tested Staphylococcus aureus strains, including drug‑resistant strains. By acting via a cell-surface mechanism it affects the bacterial membrane permeability and integrity, leading to cell death. XF-73 has already been through seven successful Phase 1/2a clinical trials showing it is safe and delivers a rapid antibacterial action. In standard microbiology studies XF drugs have demonstrated a unique no/low resistance profile that means that XF compounds have the potential to deliver novel drugs that are clearly differentiated from traditional antibiotics where resistance limits their utility.
XF-73 is being studied for the prevention of post-surgical staphylococcal infections. In the US, there are approximately 40 million surgeries per annum alone where the patient is at risk of a post-surgical infection. However, within this large population there are groups who are at an even higher risk of infection due to the nature of their surgery or the procedures and/or their specific hospital environment in which they are treated. These higher risk surgical procedures include cardiovascular, orthopaedic and other complex surgeries. Destiny Pharma estimates that this totals approximately 14 million US surgeries per year, with this figure set to rise within the context of an ageing population.
- Destiny Pharma plc
- Destiny Pharma plc