Melbourne, Australia, 15th June 2021. Akaal Pharma Pty Limited (Akaal Pharma) today announced that it’s novel and differentiated Spingosine-1-Phosphate receptor subtype-1 (S1P1) agonist and lead drug candidate “AK-119” has shown efficacy in animal models of neuropathic pain. We tested AK-119 in neuropathic and nociceptive animal model of pain with significant pain-relieving effect in both disease models. The AK-119 has differentiated safety profile with low and reversible lymphopenia and no signs of bradycardia, both in preclinical animals and humans. In our Phase-1 oral human clinical study, AK119 displayed a differentiated safety profile with no signs of bradycardia, dyspnoea or induction of severe immune suppression after single or multiple day dosing in humans. Opioid crisis has caused the much need in search of novel and safer pain medications. Treating neuropathic pain without persistent lymphopenia with S1P1 drug/modulator is a challenge and limits their use where we believe AK-119 is the answer.
Earlier in preclinical study, AK-119 shown similar efficacy at the dose level 1x to 3x of drug Gilenya but superior safety profile in an animal model of Multiple Sclerosis (MS). The 16x higher oral doses of AK119 administered in humans compared to Gilenya’s therapeutic oral dose showed significant lower immune suppression and was bradycardia safe.
Neuropathic pain is associated with several diseases including diabetes, cancer and other. The treatment options are opiates, cannabinoid those are associated with high effect, respiratory depression, constipation and more. The safe and effective treatment of pain is larger global need.
“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, autoimmune, neuronal and vascular diseases specifically pruritus, neuropathic pain, atopic dermatitis, psoriasis, alopecia areata, multiple sclerosis, ulcerative colitis and other diseases. For more information, please visit www.akaalpharma.com
Contacts
Akaal Pharma Pty Ltd
Dr Damian Grobelny and 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
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