06 Nov 2019 – Destiny Pharma to present at the World Anti‐Microbial Resistance Congress 2019

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

Destiny Pharma to present at the World Anti‐Microbial Resistance Congress 2019

Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel anti‐microbial drugs that address clear commercial opportunities and also address the global problem of anti‐microbial resistance (AMR), announces that Neil Clark, Chief Executive Officer of Destiny Pharma, will present on the potential of the Company’s XF Drugs to address the threat of AMR at the World Anti‐Microbial Resistance Congress on 7‐8 November, 2019 in Washington D.C, US.

About World Anti‐Microbial Resistance Congress
The World Anti‐Microbial Resistance Congress has been the only commercially focused conference globally of its kind, since 2015. Launched during the release of key reports such as the AMR Review and a Scientific Roadmap for Antibiotic Discovery, the World AMR Congress has brought attention to the threats of this emerging crisis to the global healthcare system. This AMR focused event attracts 200 speakers and over 600 attendees from over 40 countries.

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 and commercialisation 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 XF‐73
XF‐73 is a synthetic anti‐microbial 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 I/II 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 studies 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 particular 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.

16 Oct 2019 – Positive Phase 1 results published in journal

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

Positive results published from an independent (US National Institute of Health) XF-73 phase 1 clinical trial in a peer reviewed journal


The publication in the Journal of Global Antimicrobial Resistance concluded that application of a nasal gel formulation of XF-73 in healthy volunteers was safe, well tolerated and generated minimal side effects

Treatment with XF-73 was also associated with a rapid reduction in nasal Staphylococcus aureus in all subjects; nasal carriage of the bacteria is the source of the majority of post-surgical bacterial infections

The same nasal formulation is being used in the Company’s phase 2b trial assessing the microbiological effect of XF-73 on nasal S. aureus in patients scheduled for cardiac surgery and at high risk of post-operative S.aureus/MRSA infection; headline results continue to be expected in mid-2020
 

Brighton, United Kingdom – 16 October 2019 Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel antimicrobial drugs that address clear commercial opportunities and also address the global problem of antimicrobial resistance (AMR), notes the publication of results from a positive phase 1 clinical study in 60 healthy US volunteers using a nasal gel formulation of its lead drug, XF-73 (exeporfinium chloride), in the peer reviewed Journal of Global Antimicrobial Resistance [Yendewa GA, Griffiss JM, Jacobs MR et al; J. Glob. Antimicrob. Resist. 2019 Oct 7. pii: S2213-7165(19)30250-4. doi: 10.1016/j.jgar.2019.09.017]. The headline results from this study were previously announced by Destiny Pharma on 5 September 2016.

The reported US study was independently conducted and sponsored by the National Institute of Allergy and Infectious Diseases, part of the US National Institutes of Health (NIH). In addition to the study reporting a favourable safety and local tolerability profile of the nasal gel formulation (the primary objective), the study also noted, as expected, that exposure to XF-73 produced a rapid reduction in levels of nasal S. aureus in all subjects.

Destiny Pharma is initially developing a nasal gel formulation of XF-73 as a novel therapy to prevent post-surgical infection, including those from methicillin resistant S. aureus (MRSA), as nasal carriage is the source of >80% of S.aureus/MRSA post-surgical bacterial infections. The Company is currently conducting a 200 patient multi-centre, randomised, blinded, placebo-controlled phase 2b study of a single concentration of XF-73 nasal gel. This is to assess the anti-staphylococcal effect of XF-73 on S. aureus nasal carriage in US and European patients scheduled for cardiac surgical procedures deemed to be at high risk of post-operative S. aureus infection. Headline results from the trial are anticipated in mid-2020.

Neil Clark, CEO of Destiny Pharma, commented:
“The full results from this positive phase 1 clinical study, independently conducted and sponsored by the NIH, underscores our confidence in the potential of XF-73 as a novel treatment to prevent the occurrence of post-surgical S. aureus bacterial infections which is a significant commercial opportunity. Importantly, there is no evidence to date suggesting that XF-73 causes bacterial resistance which is in contrast to current preventative treatments such as the application of the antibiotic mupirocin, which the use of is increasingly blunted by the rising incidence of resistant strains of S. aureus. We look forward to reporting headline data in mid-2020 from our ongoing 200 patient phase 2b trial that is assessing the ability of XF-73 to reduce nasal levels of S. aureus in patients at high risk of infection that are undergoing surgery.”

Abstract in full
Yendewa GA, Griffiss JM, Jacobs MR etc al; J. Glob. Antimicrob. Resist. 2019 Oct 7. pii: S2213-7165(19)30250-4. doi: 10.1016/j.jgar.2019.09.017

OBJECTIVES:
There is conflicting data on the success of mupirocin as an effective decolonizing regimen for Staphylococcus aureus (SA) carriage, in part due to increasing drug resistance. This multi-center, randomized, open-label, prospective phase 1 study compared the safety and local tolerability of two nasal formulations of XF-73, a novel porphyrinic antibacterial drug with rapid intrinsic activity against SA.

METHODS:
The study was conducted in 2 dosing cohorts and enrolled 60 healthy adults. In Part 1, 8 non-SA carriers were randomized to 2 groups of 4 subjects in each arm and were treated with the new formulations of XF-73 in concentrations of 0.5 mg/g 2% gel and 2 mg/g 2% gel, respectively. In Part 2, 52 healthy persistent SA carriers were randomized to 4 groups of 13 subjects in each arm and were treated with three different concentrations of XF-73 (0.5 mg/g 2% gel, 2 mg/g 2% gel and 0.5 mg/g 4% gel) or a 4% viscosified placebo gel, respectively. Plasma pharmacokinetics (PK) and pharmacodynamics (PD) studies were performed. Anti-staphylococcal activity was assessed as the presence or absence of SA and by quantification of the level of colonization using a semi-quantitative scale (SA score).

RESULTS:
56 subjects (8/8 from Part 1 and 48/52 from Part 2) completed the study, with 47/60 comprising the PK population and 48/60 the PD population. There was no measurable systemic absorption of XF-73 from nasal application. Treatment with XF-73 was associated with a rapid diminution in the SA scores in all subjects. The most common treatment emergent adverse events (TEAE) reported were rhinorrhea and nasal dryness (15.5% each in Part 1 and Part 2). TEAEs were mostly mild and resolved spontaneously.

CONCLUSION:
XF-73 was found to be safe and was tolerated with minimal side effects at doses of 0.5 mg/g 2% gel and 2 mg/g 2% gel in healthy volunteers. These findings support moving on to Phase 2 trials to further evaluate the efficacy of XF-73.

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 Adviser and Joint Broker)
Geoff Nash /Anthony Adams, Corporate Finance
Alice Lane, Corporate Broking
+44 (0)20 7220 0500

WG Partners (Joint Broker)
Nigel Barnes / Claes Spång / Nigel Birks
+44 (0)20 3705 9321

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 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

23 Sep 2019 – Directorate change

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

Directorate change

Brighton, United Kingdom – 23 September 2019 – Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development of novel antimicrobial drugs to address the global crisis caused by antimicrobial resistance (AMR), today announces that after 18 years on the Board, Joe Eagle a Non-Executive Director,  has decided to step down from the Board with effect from today. Joe was instrumental in the financing and strategic direction of Destiny as a private company and brought both pharmaceutical and marketing expertise to the development of the lead candidate, XF-73 for the prevention of post-surgical infections. A search for a replacement is underway.

Nick Rodgers, Chairman of Destiny Pharma, commented:

“On behalf of Destiny Pharma, I would like to thank Joe for his considerable contribution to the Company throughout its development as a private company and the transition onto the AIM market. Joe’s understanding of the pharma market and company development has been of great value to Destiny and I am sorry to see him go. We wish him all the very best for the future” .

Joe Eagle, Non-Executive Director, commented:

“I continue to believe that Destiny Pharma, through its XF platform, will develop unique and life-saving antimicrobials to counter the worldwide threat of antimicrobial resistance. I have seen the development of the Company from a small private enterprise to a successful, asset rich public company and wish all the members of the company every success with their future endeavours. It has been a privilege to work with you all.”

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