Inflazome’s Somalix Demonstrates Positive Safety, Tolerability and Pharmacodynamic Profile in its Phase I Study

• Results from the first-in-human study showed excellent safety, tolerability and pharmacokinetics in healthy subjects resulting in target engagment at all doses tested. These results support the progression of Somalix into Phase II studies this year.

• Somalix is a potent and selective NLRP3 inflammasome inhibitor under development as an orally available, peripherally-restricted drug for inflammatory diseases.

DUBLIN & CAMBRIDGE, United Kingdom & BRISBANE, Australia--(BUSINESS WIRE)--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 its investigational drug, Somalix. Somalix is a small molecule, peripherally-restricted inhibitor of the NLRP3 inflammasome. The Phase I data showed excellent safety and tolerability, while pharmacokinetics showed linear increase with dose which could be correlated with pharmacodynamic response. The results further validate Inflazome’s technology platform and support the progression of Somalix into Phase II clinical trials in the second quarter this year.

Activation of the NLRP3 inflammasome in the body is implicated in many diseases caused by chronic, uncontrolled inflammation. The Phase I study was a first-in-human, single-centre, double blinded and randomised trial that demonstrated excellent safety or tolerability in healthy, adult participants.

Subject to positive Phase I study results, Inflazome also intends to subsequently progress its second investigational drug, Inzomelid, into Phase II studies this year. Inzomelid is an orally available, brain-penetrant small molecule, intended for treatment of debilitating inflammatory diseases of the brain.

Thomas Jung, Chief Medical Officer of Inflazome, commented,“We are very pleased to have progressed our investigational drug, Somalix, through a first-in-human Phase I study and to have demonstrated safety, tolerability and pharmacodynamic response. We can now accelerate Somalix to fulfill its potential through multiple Phase II studies. We are expecting further data read outs for our investigational brain-penetrant drug Inzomelid very soon and look forward to progressing our pipeline to address inflammatory diseases with significant unmet medical need.”

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.