17 Sep 2020 – Update on Phase 2b clinical study of lead asset XF-73 in the prevention of post-surgical infections

Destiny Pharma plc
(“Destiny Pharma” or “the Company”)

Update on Phase 2b clinical study of lead asset XF-73 in the prevention of post-surgical infections

Recruitment on track to complete by year-end and report results in early 2021

Brighton, United Kingdom – 17 September 2020 – Destiny Pharma plc (AIM: DEST), a clinical stage biotechnology company focused on the development of novel products to prevent life threatening infections today announces an update on it its XF-73 Phase 2b clinical study with 88 patients out of the target of 125 now recruited.  There is good momentum in patient recruitment which we expect to continue into the Autumn.

The Phase 2b clinical study is recruiting patients undergoing open heart surgery in United States and Europe. Barring any further impact from COVID-19 the study is on plan to complete recruitment by the end of 2020 and report results in Q1 2021.

Neil Clark, Chief Executive Officer of Destiny Pharma, said: “We are very pleased to report a  significant increase in the screening and recruitment of patients in our lead clinical study testing XF-73 as a novel product preventing the incidence of post-surgical infections such as MRSA. In the past few months we have agreed a protocol amendment with the FDA and also reported excellent interim safety data and are looking forward to completing recruitment and reporting the results.”

Details of Phase 2b Study

The ongoing 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 Staphylococcal aureus nasal carriage in 125 patients scheduled for open heart surgery

The Phase 2b study 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 clinical efficacy of XF-73 versus placebo in reducing nasal Staphylococcus aureus carriage in healthy volunteers.

For further information, please contact:

Destiny Pharma plc
Neil Clark, CEO
Shaun Claydon, CFO
pressoffice@destinypharma.com
+44 (0)1273 704 440

Optimum Strategic Communications
Mary Clark, Shabnam Bashir, Manel Mateus
Tel: +44 (0) 203 174 1789
DestinyPharma@optimumcomms.com

finnCap Ltd (Nominated Advisor Joint Broker)
Geoff Nash /Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0)20 7220 0500

WG Partners (Joint Broker)
Nigel Barnes / Claes Spång / Nigel Birks
+44 (0) 203 705 9330

About Destiny Pharma

Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development and commercialisation of novel medicines that can prevent life threatening infections.  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 anti-microbial resistance has become a global imperative recognised by the World Health Organization (WHO) and the United Nations, as well as the G7 and the G20 countries.  Destiny Pharma is also collaborating with SporeGen® to co-develop a novel, preventative product for COVID-19. For further information, please visit https://www.destinypharma.com

07 Sep 2020 – Destiny Pharma and SporeGen® announce collaboration and Innovate UK grant award to co-develop novel, preventative treatment for COVID-19

Destiny Pharma and SporeGen® announce collaboration and Innovate UK grant award to co-develop novel, preventative treatment for COVID-19

  • SPOR-COV prophylactic approach targets the innate immune system with potential to develop COVID-19 protection within a few days of treatment
  • Innovate UK grant of £800,000 to support SPOR-COV™ programme over the next 18 months
  • Expands Destiny Pharma’s novel pipeline targeted at preventing infections

Brighton, United Kingdom – 7 September 2020

Destiny Pharma plc (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), today announces that it has entered into a collaboration agreement with SporeGen Limited (“SporeGen”), a UK biotechnology company working exclusively on Bacillus and its applications, to co-develop SporeGen’s SPOR-COV product as a novel, preventive treatment for COVID-19.

Under the agreement, the parties will share any costs and commercial returns from SPOR-COV and plan to complete a pre-clinical programme with the aim of being ready to enter the first human clinical trials within 18 months. Destiny Pharma’s expertise in pre-clinical and clinical drug development will be combined with SporeGen’s world leading understanding of Bacillus bacterial spores to progress the SPOR‑COV project.

The SPOR‑COV product consists of a proprietary formulation of Bacillus bacteria that will be administered nasally as a spray. SPOR-COV has already been shown by SporeGen to provide complete (100%) protection in preclinical models of influenza virus. SporeGen has IP protection supporting the SPOR‑COV approach and this will be expanded during the project.

SPOR-COV is different to vaccines in that it utilises the innate immune system with the aim of developing COVID-19 protection a few days after dosing. As an “easy to use” first line of defence, it has the potential to reduce COVID-19 infection rates and transmission significantly. The final SPOR-COV product is planned to be straightforward to produce at high volumes and at low cost. Additional attributes are that it could be stockpiled almost indefinitely without the need for cold chain refrigeration as it is a very stable product. It could be made available globally as a cost-effective measure in the fight against COVID-19 as well as new COVID strains and other respiratory viral infections.

£800,000 grant from Innovate UK (IUK) to support SPOR-COV™ preclinical programme

Destiny Pharma and SporeGen are also very pleased to announce that IUK has awarded a grant of £800,000 to fund the majority of the £1 million cost of the initial SPOR-COV programme. The preclinical efficacy work will be undertaken in collaboration with Professor Aras Kadioglu, at University of Liverpool who is Professor of Bacterial Pathogenesis in the Department of Clinical Infection, Microbiology & Immunology,  where he heads the Bacterial Pathogenesis and Immunity group and is a leading expert in respiratory infection models and host immunity to infection. The manufacturing and formulation development work will be carried out by HURO, an experienced manufacturer of bacterial product formulations based in Vietnam and part of PAN Group. The plan is to complete the required pre-clinical safety and efficacy studies and also develop the manufacturing process in the next 18 months and be ready to commence the first human clinical studies thereafter.

Professor Simon Cutting, Chief Executive of SporeGen, said: “The SPOR-COV platform has already been shown to be effective against pandemic flu by targeting the innate immune system. As such, SPOR-COV potentially has value as a universal system for combatting other viral diseases such as COVID-19. If successful, we foresee a novel approach against COVID-19 and for future, similar pandemics. The SPOR-COV approach, unlike traditional vaccination, focuses on innate immunity and may not be impaired by new mutational variants. A further attribute of SPOR-COV is that it can be produced and stockpiled with ease and does not require a cold-chain. Prima facie our approach is simple and offers a potential new approach in the fight against one of the most serious diseases to afflict mankind”.

Neil Clark, Chief Executive Officer of Destiny Pharma, said: “We are excited to announce the collaboration with SporeGen to co-develop their SPOR-COV product to prevent COVID-19 infections and the concurrent award of significant grant funding from Innovate UK. We are also pleased to be working with Professor Kadioglu at the University of Liverpool who has world class virology expertise. Destiny Pharma is committed to building a novel pipeline targeted at preventing infections and is very pleased to now be working with partners on the SPOR-COV project alongside our existing in-house XF platform.  The ongoing coronavirus pandemic has highlighted powerfully the need for innovation in developing new treatments to prevent and manage both viral and bacterial infections and Destiny Pharma remains committed to developing cost-effective products that meet this medical need”.

 ENDS

The information communicated in this announcement is inside information for the purposes of Article 7 of EU Regulation 596/2014.

For further information, please contact:

Destiny Pharma plc
Neil Clark, CEO
Shaun Claydon, CFO
pressoffice@destinypharma.com
+44 (0)1273 704 440

SporeGen Limited
Professor Simon Cutting CEO
Kim Oanh Nguyen, COO
s.cutting@sporegen.com
+44-(0)7691 2090/+44-(0)7900 408043

Optimum Strategic Communications
Mary Clark, Shabnam Bashir, Manel Mateus
Tel: +44 (0) 203 174 1789
Email: DestinyPharma@optimumcomms.com

finnCap Ltd (Nominated Advisor Joint Broker)
Geoff Nash / Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0)20 7220 0500

WG Partners (Joint Broker)
Nigel Barnes / Claes Spång / Nigel Birks
+44 (0) 203 705 9330

About Destiny Pharma
Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development of novel medicines from its XF Platform that represent a new approach to the 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 anti-microbial 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

About SporeGen
SporeGen Limited was founded in 2012 as a biotech start up at the Royal Holloway University of London and was spun-out in 2017. The company is now situated at the London Bioscience Innovation Centre in central London. The company’s focus has been on development of novel prophylactic and therapeutic products including vaccines. The company has worked extensively with spores (Bacillus/Clostridia) and were the first to use spores as vaccine delivery vehicles including coordination of a Phase 1 study of a mucosal vaccine. The company has licensed a number of interventions to companies including large global biotechnology companies. The company has a number of pipeline products including an oral vaccine to C. difficile infection that has been taken to phase 1 clinical studies. The company was founded by Professor Simon Cutting who is a leading expert in the bacteria Bacillus and its potential application as a medical treatment in human health.  Professor Cutting is a bacterial geneticist with over 35 years of experience with Bacillus since graduating from Oxford University with a D. Phil in 1986. After spending 7 years in the renowned laboratory of Professor Richard Losick at Harvard University Biological Laboratories (USA) he was as an Assistant Professor at the University of Pennsylvania Medical School in Philadelphia. He returned to the UK in 1996 where he is a Professor at the Royal Holloway, University of London. For further information please visit http://www.sporegen.com

About Innovate UK
Innovate UK drives productivity and economic growth by supporting businesses to develop and realise the potential of new ideas. Innovate UK connect businesses to the partners, customers and investors that can help them turn ideas into commercially successful products and services and business growth.

Innovate UK fund business and research collaborations to accelerate innovation and drive business investment into R&D. Our support is available to businesses across all economic sectors, value chains and UK regions. Innovate UK is part of UK Research and Innovation. For more information visit www.innovateuk.ukri.org

UKRI Ideas to Address COVID-19
This UKRI (United Kingdom Research and Innovation) competition opened in March 2020 as a call for short-term projects addressing and mitigating the health, social, economic, cultural and environmental impacts of the COVID-19 outbreak across areas within UKRI’s remit.

 

17 Aug 2020 – Destiny Pharma welcomes NBIC #BiofilmAware campaign, launched today

Destiny Pharma, as an NBIC industrial partner, is currently working on three NBIC funded research projects in collaboration with expert teams at the Universities of Cardiff, Sheffield and Southampton.

The XF drug platform has demonstrated efficacy against bacteria in biofilms and we are looking forward to advancing these research assets towards clinical trials.  Bacterial and fungal biofilms play an important role in a range of serious conditions, ranging from catheter-associated infections, chronic wound infections, ventilator-associated pneumonia and chronic infections in cystic fibrosis.

For further information, click on link below:
NBIC Launch #BiofilmAware Campaign

11 Aug 2020 – Positive interim safety review of Phase 2b clinical trial of lead asset XF-73 in the prevention of post-surgical bacterial infections

Destiny Pharma plc
(“Destiny Pharma” or “the Company”)

Positive interim safety review of Phase 2b clinical trial of lead asset XF-73 in the prevention of post-surgical bacterial infections

Brighton, United Kingdom – 11 August 2020 – Destiny Pharma plc (AIM: DEST), a clinical stage biotechnology company focused on the development of novel treatments for hospital infections that address the global challenge of antimicrobial resistance (AMR), announces a positive interim safety review has been completed by an Independent Data Monitoring Committee (IDMC) of the Company’s ongoing Phase 2b study of its lead asset XF-73 in the prevention of post-surgical bacterial infections.

Further to the announcement on 27 July 2020 detailing a US Food and Drug Administration approved clinical protocol amendment to the Phase 2b study, the IDMC has reviewed safety data from the first 75 cardiac surgery patients who have completed study treatment. Adverse event data, including safety laboratory results, incidence of post-operative infections, ear, nose, and throat examinations, as well as sense of smell tests were reviewed by the IDMC. Based on their evaluation, the IDMC has recommended that the study can continue without any modifications to the protocol. Recruitment into the study remains on track to complete by the end of 2020.

Neil Clark, Chief Executive Officer of Destiny Pharma, commented:
“We are very pleased the IDMC has concluded that there are no safety concerns in the patients treated in the Phase 2b study to date and that the study can continue as planned. This is consistent with our previous experience of testing XF-73 in several clinical studies. We believe XF-73 nasal gel has the potential to become a well-tolerated, novel and effective treatment for the prevention of post-surgical Staphylococcal infections and represents a significant commercial opportunity. We are now two thirds of the way through the study and look forward to completing recruitment by the end of 2020.”

The ongoing 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 Staphylococcal aureus nasal carriage in 125 patients scheduled for surgical procedures deemed to be at high risk of post-operative Staphylococcal aureus infection.

The Phase 2b study 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 clinical efficacy of XF-73 versus placebo in reducing nasal Staphylococcus aureus carriage in healthy volunteers.

For further information, please contact:

Destiny Pharma plc
Neil Clark, CEO
Shaun Claydon, CFO
pressoffice@destinypharma.com
+44 (0)1273 704 440

FTI Consulting
Simon Conway / Victoria Foster Mitchell
destinypharma@fticonsulting.com
+44 (0) 20 3727 1000

finnCap Ltd (Nominated Advisor Joint Broker)
Geoff Nash /Kate Bannatyne, Corporate Finance
Alice Lane, Corporate Broking
+44 (0)20 7220 0500

WG Partners (Joint Broker)
Nigel Barnes / Claes Spång / Nigel Birks
+44 (0) 203 705 9330

About Destiny Pharma
Destiny Pharma is an established, clinical stage, innovative biotechnology company focused on the development of novel medicines from its XF Platform that represent a new approach to the 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 anti-microbial 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

The information communicated in this announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No. 596/2014.

10 July 2020 – Pharma companies join forces to launch $1 billion fund to develop new antibiotics by 2030

Twenty-three leading biopharmaceutical companies have joined forces to invest $1 billion in a fund to develop new antibiotics, which are needed urgently to fight the worldwide rise in antimicrobial-resistant superbugs. The AMR Action Fund, aims to bring 2-4 new antibiotics to patients by 2030. Through the AMR Action Fund, pharmaceutical companies will join forces with philanthropies, development banks, and multilateral organizations to strengthen and accelerate antibiotic development. The Fund will focus on urgent public health needs. It will provide much needed financial resources, as well as important technical support to help biotech companies bring novel antibiotics to patients.

Destiny Pharma CEO Neil Clark said ”We welcome this significant new fund supporting novel drug development addressing AMR. The world needs new antinfective drugs and Destiny Pharma is one of the few biotech companies dedicated to this global clinical need. The new pharma backed fund is clear recognition of the clinical need and is the latest in a series of new initiatives from regulators, governments and healthcare investors to support innovation that addresses AMR”.