Pharmaceuticals manufacturer and developer Anatara Lifesciences Ltd (ASX:ANR) announced today that it has received Human Research Ethics Committee (HREC) approval to begin clinical trials of its Gastrointestinal Re-programming complementary medicine (GaRP).
Given that the study would involve human participants, Anatara needed to complete pre-clinical safety and efficacy testing prior to approval.
The company has already undertaken site initiation procedures for patient recruitment planned for March 2021.
Anatara’s GaRP complementary medicine will address two human gastrointestinal disorders: irritable bowel syndrome (IS) and inflammatory bowel disease (IBD).
IBS affects 11% of the global population. Meanwhile, an estimated five million people globally suffer from IBD.
Current pharmaceutical treatments are ineffective and may induce debilitating side-effects. In 2018, expenditure on gastrointestinal supplements and OTC digestive remedies in the US reached US$8 billion.
Commenting on the milestone development, Anatara CEO Steve Lydeamore said: “There is a major unmet need and significant market opportunity for an evidence-based complementary medicine for IBS.
“Human ethics approval is another milestone for Anatara and clinicians and patients seeking effective remedies to address IBS.
“Anatara’s GaRP has demonstrated that it has the potential to manage the devastating symptoms experienced by IBD and IBS patients, by addressing processes that contribute to the pathophysiology of these chronic bowel conditions.”