Inzomelid completes Phase I studies and shows positive results in the treatment of Cryopyrin-Associated Periodic Syndrome (CA...
26 März 2020 - 8:00AM
Business Wire
- The Phase I study demonstrated Inzomelid has an
excellent safety, tolerability and pharmacokinetic profile in
healthy subjects, with dose-dependent target engagement
- Inzomelid also delivered positive preliminary results
from a patient with Cryopyrin-Associated Periodic Syndrome
(CAPS)
- Inzomelid is a potent, selective, brain-penetrant NLRP3
inflammasome inhibitor intended for treatment of debilitating
inflammatory diseases of the brain and is expected to move into
Phase II trials this year
Inflazome (inflazome.com), the
pioneering inflammasome biotech company developing multiple drugs
that stop harmful inflammation, today announces the successful
completion of a Phase I study of Inzomelid, alongside positive
results from a Cryopyrin-Associated Periodic Syndrome (CAPS)
patient dosed with Inzomelid. CAPS is an autoinflammatory orphan
disease driven by mutated NLRP3. The results support the
progression of Inzomelid into Phase II clinical trials.
Inzomelid is a selective, orally available small molecule
inhibitor of the NLRP3 inflammasome. Activation of the NLRP3
inflammasome is implicated in many diseases caused by chronic,
harmful inflammation.
Drug exposures in the double blinded and randomised Phase I
trial in healthy subjects increased linearly with dose, and
correlated with markers of target engagement. The drug also
demonstrated an excellent safety and tolerability profile.
Preliminary analysis from the CAPS part of this study showed
that a patient with a confirmed NLRP3 mutation suffering from a
CAPS-related flare showed rapid clinical improvement within hours
and remission within days. A follow-on Phase II trial is planned to
identify the best dose for CAPS patients.
Inzomelid follows Inflazome’s other NLRP3 inflammasome
inhibitor, Somalix, in successfully completing Phase I trials.
Somalix, an orally available, peripherally-restricted drug for
inflammatory diseases, also demonstrated excellent safety,
tolerability and pharmacokinetics in healthy subjects and is
expected to enter Phase II trials in 2020.
Dr. Thomas Jung, Chief Medical Officer of Inflazome,
commented, “The positive Phase I results from our two lead
candidates, Inzomelid and Somalix, further validate our technology
platform as we head with real momentum towards multiple Phase II
trials later this year. The Inzomelid CAPS data also represents a
very exciting step for the field in orphan indications. We believe
this is the first example of positive data in a human disease
setting with a small-molecule NLRP3 inhibitor. Our primary
motivation is to develop drugs for which a high unmet medical need
exists, so we are pleased to see that Inzomelid has demonstrated
clear clinical potential.”
About Inflazome
Inflazome is a biotech company leading the development of orally
available drugs to address clinical unmet needs in inflammatory
diseases by targeting inflammasomes. Inflammasomes are understood
to drive many chronic inflammatory conditions, from Parkinson’s and
Alzheimer’s to asthma, inflammatory bowel disease, chronic kidney
disease, cardiovascular disease, arthritis and NASH. Inflazome has
two clinical-stage investigational drugs. Inzomelid is under
development as an orally available, brain-penetrant drug and
Somalix is under development as an orally available,
peripherally-restricted drug. Both will address clinical unmet
needs in inflammatory conditions. Inflazome is headquartered in
Dublin, Ireland, with offices in Cambridge, UK and Brisbane,
Australia.
To learn more visit: inflazome.com
About the NLPR3 Inflammasome
Activated NLRP3 acts as a ‘danger sensor’ in the body to release
the pro-inflammatory cytokines IL-1β, IL-18 and induce
uncontrolled, lytic cell death (pyroptosis). These processes lead
to chronic inflammation, and as such, NLRP3 has been implicated in
a large number of diseases.
About Cryopyrin-associated periodic syndromes
Cryopyrin-associated periodic syndromes (CAPS), also called
cryopyrin-associated autoinflammatory syndromes, are three diseases
related to a defect in the NLRP3 gene. CAPS encompasses neonatal
onset multisystem inflammatory disease (NOMID), Muckle-Wells
syndrome (MWS) and familial cold autoinflammatory syndrome (FCAS).
The differences in these diseases lie in their severity and the
organs involved.
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Inflazome: Dr Jeremy Skillington | VP Business
Development E: j.skillington@inflazome.com Media:
FTI Consulting UK &
International | Ciara Martin/Tim Stamper T: +44 20 37271000 Ireland
& International | Jonathan Neilan/Patrick Berkery T: +353 1
7650800 E: StratCommEMEAInflazome@fticonsulting.com