REG - Ondine Biomedical - Ondine commencing US Phase 3 clinical trial

Ondine BiomedicalAnnouncement

17/12/2024 07:00

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RNS Number : 3059Q  Ondine Biomedical Inc.  17 December 2024

ONDINE BIOMEDICAL INC.

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

 

Ondine commencing US Phase 3 clinical trial

 

Ondine Biomedical Inc. (LON: OBI), a Canadian life sciences company pioneering
light-activated antimicrobial treatments, announces the imminent start of the
LANTERN Phase 3 clinical trial of its novel nasal photodisinfection
technology, branded as Steriwave(®) outside the US. The U.S. Food and Drug
Administration (FDA) has raised no objections to starting the study during its
statutory 30-day review period of the Company's Investigational New Drug (IND)
amendment, thereby allowing the trial to begin.

 

Preparations for this pivotal trial are nearly complete, with all 14 hospital
sites selected and two additional back-up sites identified. Ondine has already
initiated four sites and has been conducting staff training to ensure
readiness for patient enrolment. Patient recruitment activities are beginning
and will continue through early 2025, with the final patient expected to enrol
in mid-2025. Early trial results are projected for release in Autumn 2025.

 

The Phase 3 trial is being conducted in collaboration with HCA Healthcare, a
leading healthcare provider in the United States.  This group-randomized
crossover study will enroll approximately 5,000 surgical patients undergoing
cardiac, orthopedic, vascular, neuro or radical mastectomy surgeries. The
study will compare standard infection prevention practices with and without
Ondine's nasal photodisinfection technology.

 

CEO Carolyn Cross stated:

 

"The significant recent funding has been pivotal in enabling us to move
forward with the launch of our US Phase 3 trial before the end of the year.
This critical study marks a key milestone in our pursuit of FDA approval for
our nasal photodisinfection technology. We're thrilled by the strong
engagement from our clinical trial investigators and hospital research teams
and are excited to commence the trial with the support of our clinical trial
partner, HCA Healthcare."

 

Ondine's nasal photodisinfection is a 5-minute, non-invasive procedure that
rapidly decolonizes the nose of infection-causing pathogens without the use of
antibiotics. This innovative approach avoids contributing to antimicrobial
resistance (AMR). The process involves applying a proprietary photosensitive
agent to each nostril with a nasal swab, followed by illumination with a
specific wavelength of red light. The light activates the agent, producing an
oxidative burst that destroys bacteria, viruses and fungi in a single
treatment.

 

Nasal decolonization is recommended in the 2016 WHO Global guidelines for the
prevention of surgical site infections, 1  and the Society for Healthcare
Epidemiology of America (SHEA) guidelines, published in May 2023, recommend
nasal decolonization for major surgical procedures. 2 

 

 

Enquiries:

 Ondine Biomedical Inc.
 Carolyn Cross, CEO                                            +001 (604) 665 0555

 Singer Capital Markets (Nominated Adviser and Joint Broker)
 Phil Davies, Sam Butcher                                      +44 (0)20 7496 3000

 RBC Capital Markets (Joint Broker)
 Rupert Walford, Kathryn Deegan                                +44 (0)20 7653 4000

 Vane Percy & Roberts (Media Contact)
 Simon Vane Percy, Amanda Bernard                              +44 (0)77 1000 5910

 

 

About Ondine Biomedical Inc.

 

Ondine Biomedical Inc. is a Canadian life sciences company and leader in
light-activated antimicrobial therapies (also known as 'photodisinfection').
Ondine has a pipeline of investigational products, based on its proprietary
photodisinfection technology, in various stages of development.

 

Ondine's nasal photodisinfection system has a CE mark in Europe and is
approved in Canada and several other countries under the name Steriwave(®).
In the US, it has been granted Qualified Infectious Disease Product
designation and Fast Track status by the FDA and is currently undergoing
clinical trials for regulatory approval. Products beyond nasal
photodisinfection include therapies for a variety of medical indications such
as chronic sinusitis, ventilator-associated pneumonia, burns and other
indications.

 

 

 

 1   Surgical Site Infection Prevention: Key facts on decolonization of nasal
carriers of Staphylococcus aureus. World Health Organization. (link
(https://cdn.who.int/media/docs/default-source/integrated-health-services-(ihs)/ssi/fact-sheet-staphylococcus-web.pdf?sfvrsn=7e7266ed_2)
)

 

 2  Calderwood MS, Anderson DJ, Bratzler DW, et al. Strategies to prevent
surgical site infections in acute-care hospitals: 2022 Update. Infect Control
Hosp Epidemiol. 2023;44(5):695-720. (link
(https://www.cambridge.org/core/journals/infection-control-and-hospital-epidemiology/article/strategies-to-prevent-surgical-site-infections-in-acutecare-hospitals-2022-update/2F824B9ADD6066B29F89C8A2A127A9DC)
)

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