ENA Respiratory Announces FDA IND Clearance for its Prophylactic Intranasal INNA-051 - a First-in-Class Antiviral Innate Immunomodulator
April 29 2024 - 4:00AM
ENA Respiratory, a clinical-stage pharmaceutical company developing
innate immune modulators for the prevention of complications
associated with respiratory viral infections in at-risk
populations, announces today that the U.S. Food and Drug
Administration (‘FDA’) has issued a ‘safe to proceed’ notice for
its investigational new drug (‘IND’) application for a Phase 1b
study of its novel dry powder formulation of INNA-051.
A virus-agnostic intranasal antiviral host
defence immunomodulator, INNA-051 is a potent first-in-class
agonist of toll-like receptor 2/6 (TLR2/6) which plays a key role
in recognizing pathogens and triggering the innate immune response.
Having demonstrated accelerated viral clearance and local
stimulation of antiviral host defences in a Phase IIa
proof-of-principle study using a liquid formulation in an
influenza-challenge model, ENA Respiratory has developed an
improved dry powder formulation to take into further clinical
development.
ENA Respiratory’s CEO, Christophe
Demaison, PhD said: “We are pleased that the FDA has
cleared our IND for our dry powder formulation of INNA-051, which
is expected to provide extended shelf life at room temperature. FDA
clearance is a significant milestone for the company as it supports
late-stage clinical development of INNA-051.”
In parallel with the IND application, ENA has
submitted ethics approval for a Phase 1b study in Australia. This
study is expected to be initiated in mid-2024 with the aim to
assess the safety, tolerability, pharmacodynamics, and
pharmacokinetics of the dry powder formulation of INNA-051 in older
adults.
ENA Respiratory’s Medicine Development
Leader Ruth Tal-Singer, PhD said: “The study is an
essential step in supporting our planned international seasonal
prophylaxis Phase 2b study in older adults at risk of severe
complications from viral respiratory diseases due to conditions
including diabetes, cardiovascular or lung diseases. By targeting
the innate immune system at the primary site of most viral
respiratory infections, INNA-051 has the potential to address an
unmet need in this most vulnerable population as a complementary
virus-agnostic approach to available vaccines and direct-acting
antivirals, which are often virus-specific.”
About ENA Respiratory
ENA Respiratory is a clinical-stage
pharmaceutical company tackling serious respiratory viral
infections through the development of host defence immune
modulators which locally prime and boost the body’s innate immune
response – the natural first line of defence. Being virus-agnostic,
immune modulators are complementary to often virus-specific
vaccines and existing direct-acting antivirals.
The company’s lead product, INNA-051, is a
potent agonist of toll-like receptor 2/6 (TLR2/6) which plays a key
role in recognising pathogens and triggering the innate immune
response. With a safe profile supporting prophylaxis use, it has
demonstrated accelerated viral clearance and stimulation of
antiviral host defences, including IFN Type I & III responses,
in a Phase IIa proof-of-principle study using an
influenza-challenge model. INNA-051 is being developed as a
convenient, once-a-week nasal dry powder product to prevent
complications associated with respiratory viral infections in
at-risk populations, including the elderly, those with an
underlying medical condition (including chronic lung conditions,
diabetes, kidney disease, and cardiovascular disease) and
individuals with occupational risk (e.g. first responders, military
or essential services personnel).
Headquartered in Melbourne, Australia, the
company has raised US$26M (AU$44million) in equity financing from
Brandon Capital, The Minderoo Foundation and Uniseed. It is
partnered with the COPD Foundation to support the clinical
development of INNA-051 in COPD and has been awarded a
US$8.18million contract from the U.S. Department of Defence. It is
a member BLUE KNIGHT™, a joint initiative between Johnson &
Johnson Innovation and BARDA designed to accelerate next-gen
potential solutions for future pandemics.
For more information, please visit
https://enarespiratory.com
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