Melbourne, Australia, 10th March 2020. Akaal Pharma Pty Limited (Akaal Pharma) today announced that it has novel and differentiated findings with its Spingosine-1-Phosphate receptor subtype-1 (S1P1) agonist and lead drug candidate “AK-119” in Phase-1 oral human clinical trial and a new patent application has been filed. The differentiated profile includes the devoid of bradycardia, dyspnoea and induction of severe immune suppression after single or multiple day dosing in humans. This desired profile for a S1P1 agonist has broad potential use to treat autoimmune and beyond autoimmune indications specifically in vascular and neuronal indications (psoriasis, eczema, neuropathic pain, pruritus, multiple sclerosis (MS), epilepsy/neurodegeneration, ulcerative colitis). In a head to head study, AK-119 shown similar efficacy but superior safety profile in preclinical animal model of Multiple Sclerosis (MS) compared to Gilenya. The 16x higher oral doses of AK-119 administered in humans compared to Gilenya’s therapeutic oral dose showed lower immune suppression and bradycardia safe. The data generated by Akaal in preclinical and clinical studies indicate its superiority and a clear differentiating characteristic when compared to other known S1P1 receptor agonists and those currently in the clinic.
Conventional S1P1 agonists have side effects of bradycardia and/or severe immune suppression (lymphopenia)that limits their use. AK-119 is safe, well tolerated and has not shown any the unwanted side effects associated with other S1P1 agonists (bradycardia, severe immune suppression, dyspnoea) even at high doses opening the door to safely treat autoimmune indications and more disorders such as neuropathy, neuropathic pain, neurodegeneration and vascular indications to name a few. AK-119 is a unique candidate to fill the gap of a safe long term need in the S1P1 area.
“We continue to actively prioritize and expand our developmental programs to serve the wider global community those that are suffering and where there is need of safe and effective treatment,” said Chairman of Akaal Pharma Mr B. S. Sandhu.
About Akaal Pharma Pty Ltd
Akaal Pharma is a private clinical-stage, Australian biotech company focused on advancing the clinical development of its internally discovered topical and oral small molecule drug candidates for treating inflammatory, immune and vascular diseases specifically atopic dermatitis, psoriasis, arthritis, pain, nephropathy, retinopathy, multiple sclerosis, ulcerative colitis and other diseases. For more information, please visit www.akaalpharma.com
Contacts
Akaal Pharma Pty Ltd
Dr Gurmit S Gill, Akaal Pharma Pty Ltd, #301E, Thomas Cherry Building, La Trobe University, Bundoora, VIC-3083, Australia. Tel: +61-3-9479-2584. Email: info@akaalpharma.com
Disclaimer:
Certain statements in this new release concerning Akaal Pharma business are considered “forward looking statements”. Any or all the forward-looking statements in this press release can be affected by inaccurate assumptions. Akaal Pharma undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.