REG - Ondine Biomedical - Ondine reports successful US Phase 2 trial data

Ondine BiomedicalAnnouncement

06/09/2022 07:00

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RNS Number : 3524Y  Ondine Biomedical Inc.  06 September 2022

6 September 2022

Ondine Biomedical Inc.

("Ondine Biomedical", "Ondine" or the "Company")

Ondine reports successful US Phase 2 trial data

Results show a single, 5-minute treatment of nasal photodisinfection
significantly reduces Staphylococcus aureus, a major cause of surgical site
infections, in pre-surgical patients

·    Top line results met primary endpoint and showed nasal
photodisinfection eliminated or significantly decreased Staphylococcus aureus
(S. aureus) in 92% of carriers treated per protocol (P<0.001).

·    All of the 319 subjects received a single, 5-minute nasal
photodisinfection treatment.

·    S. aureus is the primary pathogen associated with surgical site
infections (SSIs). i  (#_edn1)

·    No reportable adverse events.

Ondine Biomedical Inc. (LON: OBI) announces that its Phase 2 BENEFIT-APDT
clinical trial met the primary endpoint of bacterial load reduction after
nasal photodisinfection. Results from the study showed that nasal
photodisinfection eliminated or significantly decreased S. aureus in 92% of
carriers (P<0.001) immediately after treatment. There were no reportable
adverse events or unexpected safety issues; treatment was found to be safe and
well tolerated.

Carolyn Cross, CEO of Ondine Biomedical, commented:

"As expected, photodisinfection had a strong antimicrobial outcome, which we
believe, from our Canadian hospital experiences, will be beneficial to
pre-surgical patients. Concluding our Phase 2 trial is a key milestone that
satisfies our IPO commitment and puts us firmly on the path towards completing
the US FDA regulatory process."

The single-centre, BENEFIT-APDT open-label study was carried out at HCA
Healthcare's Memorial Health University Medical Center in Savannah, Georgia. A
total of 319 pre-surgical patients were enrolled and tested for the presence
of S. aureus in the nose. Patients were then treated with a single, 5-minute
nasal photodisinfection treatment and then re-tested.

Jason Hickok, VP of Clinical & Medical Affairs commented:

"We are pleased that the statistically significant results from the
BENEFIT-APDT trial demonstrate the positive therapeutic effect of nasal
photodisinfection. This novel therapy has the potential to be an important new
treatment option to combat surgical site infections."

Lowering surgical site infection rates has been an elusive target for
hospitals for many years. Up to 30% of the general population is nasally
colonized with S. aureus, ii  (#_edn2) significantly increasing the risk of
surgery-related infections. SSIs are the leading cause of readmissions
(about%3Ablank)  to hospital following surgery, and approximately 3% of
patients who contract an SSI die as a consequence of these infections. iii 
(#_edn3) Post-operative infections occur in up to 300,000 patients per year in
the United States and cost the US healthcare system tens of billions of
dollars a year. iv  (#_edn4)

Nicolas Loebel, Ph.D, President of Ondine, commented:

"Preventing SSIs with the use of a single, 5-minute treatment that is safe,
non-toxic, and non-antibiotic immediately prior to surgery is a completely new
paradigm for hospitals.".

Ondine's nasal photodisinfection has a CE mark for use in the EU and is
approved in Canada and several other countries under the name Steriwave™. In
the US, it has received Qualified Infectious Disease Product designation and
Fast Track status from the FDA and is currently undergoing clinical trials for
regulatory approval.

Ondine expects the full results of the Phase 2 trial to be available in
November 2022.

 

For more information, please visit:  www.ondinebio.com or contact:

 Ondine Biomedical Inc.
 Angelika Vance, Corporate Communications                                                                               +001 (1) 604 838 2702

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About Photodisinfection

Ondine's photodisinfection comprises a two-step process: the application of a
proprietary light-activated solution to each nostril using a nasal swab,
followed by illumination of the area with a specific wavelength of laser light
for less than five minutes. The photodisinfection process works by light
exciting the photodynamic solution, causing an oxidative burst that is lethal
to pathogens. A key benefit of this approach is that pathogens do not develop
resistance to the therapy.

 

About Ondine Biomedical Inc.

Ondine Biomedical Inc. is a Canadian headquartered company led by founder and
CEO, Carolyn Cross. Ondine has developed a patented, photodisinfection
technology platform used in treatment and prevention therapies for a
broad-spectrum of pathogens - including multidrug-resistant strains.
Photodisinfection is a targeted antimicrobial which uses non-thermal light to
activate a photosensitive agent. In a few minutes, this light-based therapy
destroys the pathogens through an oxidative burst without harming human
tissue.

Ondine has a pipeline of investigational products, based on its proprietary
photodisinfection platform, in various stages of development. Products include
treatment of chronic rhinosinusitis, decolonization of infections in burns and
wounds, disinfection of endotracheal tubes to reduce the incidence of
ventilator-associated pneumonia and most recently, the development of topical
antiviral therapy for the upper respiratory tract to reduce viral titres and
transmission of respiratory viruses (e.g., SARS-CoV-2, influenza, RSV, etc.).
Ondine's technology is approved in several jurisdictions and has been awarded
the CE mark, as well as Qualified Infectious Disease Product designation and
Fast Track status in the US by the FDA.

 

The information contained within this announcement is deemed to constitute
inside information as stipulated under the Market Abuse Regulations (EU) No.
596/2014, which is part of UK law by virtue of the European Union (Withdrawal)
Act 2018. Upon the publication of this announcement, this inside information
is now considered to be in the public domain.

 

 i  (#_ednref1) Klevens RM, Edwards JR, Richards CL, et al. Estimating
healthcare associated infections and deaths in US hospitals, 2002. Public
Health Rep 2007; 122:160e166.

 ii  (#_ednref2) Hidron AI, Edwards JR, Patel J, Horan TC, Sievert DM, Pollock
DA, et al. NHSN annual update: antimicrobial-resistant pathogens associated
with healthcare- associated infections: annual summary of data reported to the
National Healthcare Safety Network at the Centers for Disease Control and
Prevention, 2006-2007. Infect Control Hosp Epidemiol 2008;29:996 1011.

 iii  (#_ednref3) "Surgical Site Infections. PSNet Patient Safety Network,
AHRQ. 2019. (https://psnet.ahrq.gov/primer/surgical-site-infections)

 iv  (#_ednref4) "Surgical site infections are the most common and costly of
hospital infections." ScienceDaily. 2017.
(https://www.sciencedaily.com/releases/2017/01/170119161551.htm)

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