Dual-listed early-stage biotech company Immuron (ASX: IMC) has revealed keenly anticipated results for its phase 2 non-alcoholic steatohepatitis (NASH) clinical study.
The primary objective of the study was to evaluate the safety and efficacy of IMM-124E, at two oral dosage levels as compared with a placebo and provide proof of concept in human subjects for its unique Mechanism of Action (MoA).
The now concluded study found that Immuron’s first-in-class, oral antibody therapy IMM-124E, resulted in a “statistically significant reduction of serum LPS levels in patients with NASH,” according to Immuron.
Phasing into clinical studies
The clinical study was conducted on a total of 133 “biopsy-proven” NASH patients, who were treated with either a placebo or Immuron’s IMM-124E at regular intervals for 6 months.
After administering its therapy and evaluating the results, Immuron believes “the outcome of the trial is an important milestone toward commercialization of IMM-124E,” suggesting further clinical trials and eventual commercialisation of the therapy are now a step closer for the company.
Another conclusion from the clinical study was that, “no safety concerns or serious adverse events were associated with the study drug, as evident by serum biochemistry, haematology, vital signs, or physical examination for both treatment groups,” which effectively validates IMM-124E as a safe therapy worthy of further investigation and more thorough clinical trials.
According to Immuron, “both doses of IMM-124E in the study (600mg and 1200mg) were well tolerated therefore supporting the use of even higher doses and extended treatment periods in future clinical trials.”
Third party validation
In parallel with today’s published results, study lead Principle Investigator Professor Arun Sanyal from the Virginia Commonwealth University in Richmond, USA said: “This is truly a proof of concept for this first-in-class drug candidate.
The IMM-124E drug candidate has been developed to target LPS in the gut and prevent it translocating into the portal circulation.
The study results clearly demonstrate a statistically significant reduction of serum LPS levels in the treatment groups when compared to placebo and provides us with a proof of concept that metabolic endotoxemia can indeed be decreased using this drug candidate (IMM-124E) which targets the endotoxin LPS.”
“We are encouraged that IMM-124E, a drug with an exceptional safety profile, can lower the LPS-associated inflammatory burden and improve liver enzymes. The potential clinical applications for this drug candidate are numerous and very exciting indeed,” said Professor Arun Sanyal.
Today’s results pave the way for Immuron to assimilate its recent findings and to carry out further research.
“The proof for IMM-124E’s non-absorbable nature and excellent safety profile as reported, will allow us to conduct further clinical research aimed at maximizing the effect with potentially higher doses and longer treatment times,” said Mr Dan Peres, Senior Vice President Head of Medical at Immuron.
“Furthermore, these results support that IMM-124E offers potential as a standalone treatment or in combination with other classes of drugs,” Mr Perers added.
“Our results offer evidence of a therapeutic mechanism of action and a clear direction for further NASH studies. The growing literature implicating LPS in many diseases offers the potential for a much wider scope for LPS antagonism as a treatment modality. With IMM-124E being the world’s First-In-Class Oral LPS Antagonist we are very confident, that when combined with its exceptional safety, there are substantial opportunities ahead across a broad range of diseases,” said Dr Jerry Kanellos, Interim CEO of Immuron.
As a consequence of today’s news, Dr Jerry Kanellos is scheduled to host a teleconference with shareholders in the coming weeks, to further explain today’s NASH trial results and review Immuron’s progress towards finalising its drug candidate into a market-ready commercial product.
According to Immuron, Dr Kanellos will also visit several investor roadshow presentations over the coming months in both Australia and the US, to further showcase the company’s clinical progress and to explain “other exciting developments” at the biotech company.
Today’s news sent stock in Immuron 60% higher at market open to $0.46 a share, valuing the biotech company at around A$61 million by market capitalisation.