Greater Shepparton, Victoria, Australia, 12th May 2022. Akaal Pharma Pty Limited (Akaal Pharma) today announced that it has received a favourable preliminary patentability report from the international patent office on the novelty and inventivenessof methods of treatment with its differentiated Spingosine-1-Phosphate receptor subtype-1 (S1P1) agonist technology and lead drug candidate “AK-119”.
The oral treatment with AK-119 in a Phase-1 clinical trial presented a unique safety profile. Dose related systemic exposure with no bradycardia; no dyspnoea event was observed, and the lymphopenia (immune suppression) was mild that recovering to baseline within 24 hrs after multiple day dosing in healthy volunteers. During preclinical development the head-to-head comparison with drug Gilenya in an animal model of Multiple Sclerosis (MS); the 3x dose level of AK-119 had similar efficacy but superior safety profile, and in a Phase-1 clinical trial AK-119 was dosed at 16x higher oral dose to that of the human therapeutic oral dose of Gilenya. The drug profile of AK-119 has enormous potential in autoimmune disease as well as potential in other indications including vascular and neuronal. We have demonstrated AK-119 to be efficacious in animal models of neuropathic pain and combined with the safety profile from the Phase-1 safety study validates further development of a novel S1P1 area in neuropathic pain.
“We are now fast tracking our development in atopic dermatitis, psoriasis, alopecia and will expand to other indications. We believe AK-119 will fill the selectivity, efficacy and safety profile within the S1P1 area and we continue to actively prioritize and expand our developmental programs. At Akaal Pharma we serve the wider global community those that are suffering and where there is need for safe, affordable, 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 its internally discovered topical and oral small molecule drug candidates for treating inflammatory/immune skin and other indications specifically atopic dermatitis, psoriasis, alopecia, arthritis, neuropathy, pain, nephropathy, retinopathy, multiple sclerosis, ulcerative colitis. For more information, please visit www.akaalpharma.com
Contacts
Akaal Pharma Pty Ltd
Dr Gurmit S Gill, 89 School Road, Shepparton East, VIC-3631, Australia. Tel: +61 (3) 4800-8992. Email: Gurmit.Gill@latrobe.edu.au; 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.