Destiny Pharma. Regulatory News (DEST)

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