Destiny Pharma PLC Phase 2b trial of XF-73 completes recruitment (5179K)

TIDMDEST

RNS Number : 5179K

Destiny Pharma PLC

05 January 2021

Destiny Pharma plc

("Destiny Pharma" or "the Company")

Phase 2b clinical trial of XF-73 completes patient recruitment

Results expected in Q1 2021

Brighton, United Kingdom - 5th January 2021 - Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life threatening infections, today announces that its XF-73 Phase 2b clinical trial was fully recruited by 31 December 2020, meeting the target timeline set for the programme.

Neil Clark, Chief Executive Officer of Destiny Pharma, said : "We are very pleased to have completed enrollment in our Phase 2b clinical trial testing XF-73 nasal gel as a novel product preventing the incidence of post-surgical infections such as MRSA. We previously reported excellent interim safety data in mid-2020 and are now looking forward to announcing the full results of this study and planning the Phase 3 clinical programme. There is a global need for better treatments to prevent post-surgical infections in hospitals as recognized in the FastTrack status awarded to XF-73 by the US FDA. There is also a significant commercial opportunity for XF-73 in the hospital setting which we estimate could generate peak annual product sales of $1 billion in the US alone.

2020 was a transformational year for Destiny Pharma as we accelerated our strategy to build a world leading anti-infection company with a robust pipeline. We established a biotherapeutic/microbiome pipeline alongside our existing XF platform and are now co- developing SPOR-COV as a novel, preventive treatment for COVID-19. We also raised GBP10.4 million to acquire NTCD-M3, a Phase 3 ready biotherapeutic treatment for the prevention of C. difficile infection recurrence. The news today on our XF-73 Phase 2b study is another major milestone for the Company and we continue to look forward to announcing the study results in Q1 2021."

Details of Phase 2b Trial

XF-73 is a first-in-class drug candidate from Destiny Pharma's XF platform, initially being developed for the prevention of post-surgical staphylococcal infections, such as methicillin-resistant Staphylococcus aureus (MRSA), which cause significant complications and increased healthcare costs in the hospital setting. It has been awarded both qualifying infectious disease product (QIDP) and Fast Track status by the US FDA. The Phase 2b trial is a multi-centre, randomised, blinded, placebo-controlled study of multiple applications of a single concentration of XF-73 nasal gel to assess the microbiological effect of XF-73 on commensal Staphylococcus aureus nasal carriage in up to 125 patients scheduled for open heart surgery.

The Phase 2b trial design is closely related to the successful 2016 clinical trial, which was funded by the National Institute of Allergy and Infectious Disease (part of the US National Institute of Health) and demonstrated the efficacy of XF-73 versus placebo in reducing Staphylococcus aureus nasal carriage in healthy volunteers. Previous clinical and scientific data supports XF-73 as having a novel mechanism of action and being a safe, fast and targeted anti-infective agent. In microbiological studies it has also shown to not generate anti-microbial resistance (AMR) and therefore has the potential to have a clear advantage over older antibiotic treatments that can lead to the generation of drug resistant "superbugs".

For further information, please contact:

Destiny Pharma plc

Neil Clark, CEO

Shaun Claydon, CFO

[e-mail]

[phone]

Optimum Strategic Communications

Mary Clark, Shabnam Bashir, Manel Mateus

[e-mail]

[phone]

finnCap Ltd (Nominated Advisor Joint Broker)

Geoff Nash / Kate Bannatyne, Corporate Finance

Alice Lane, Corporate Broking

[phone]

WG Partners (Joint Broker)

Nigel Barnes / Claes Spång / Nigel Birks

[phone]

About Destiny Pharma

Destiny Pharma is a clinical stage, innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections. Its pipeline has novel microbiome-based biotherapeutics and XF drug clinical assets including NTCD-M3, a Phase 3 ready treatment for the prevention of C. difficile infection (CDI) recurrence which is the leading cause of hospital acquired infection in the US and also XF-73 nasal gel, which is in a Phase 2b clinical trial targeting the prevention of post-surgical Staphylococcal hospital infections including MRSA. It is also co-developing SPOR-COV, a novel, biotherapeutic product for the prevention of COVID-19 and other viral respiratory infections and has earlier grant funded XF research projects.

   For further information, please visit   https://www.destinypharma.com 

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January 05, 2021 02:00 ET (07:00 GMT)