Greater Shepparton, Victoria, Australia, 9th September 2022. Akaal Pharma Pty Limited (Akaal Pharma) today announced that it has processed filing to national phase, including the major markets, of its international patent application (PCT). Earlier, Akaal had received a favourable international preliminary report on patentability from the international patent office regarding the novelty and inventiveness of 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 Phase-1 clinical trial presented a unique safety profile. Dose related systemic exposure but with no bradycardia/dyspnoea event was observed. The lymphopenia (immune suppression) was mild, recovering to baseline within 24hrs after multiple day dosing in healthy volunteers. During preclinical development the head-to-head comparison with the drug Gilenya in an animal model of Multiple Sclerosis (MS), the 3x dose level of AK-119 afforded similar efficacy but with superior safety. In a Phase-1 clinical trial it was dosed at 16x higher oral doses compared to Gilenya’s therapeutic oral dose in humans. The S1P1 mode of action is an emerging mode of action for the treatment of difficult to treat indications where AK-119 with a novel safety profile has enormous use potential in and beyond autoimmune diseases, including vascular and neuronal indications. AK-119 showed significant efficacy in animal models of neuropathic pain and its human safety findings are a perfect match to develop it for neuropathic pain.
“We prioritize and expand our developmental programs to serve the wider global community where there is need for safe and effective treatment and at the same time continue to broaden and strengthen the intellectual property assets of Akaal,” 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, multiple sclerosis, ulcerative colitis, neuropathic pain. 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: +61348008992.
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.