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Akaal Pharma Initiates Phase-2 Clinical Trial of Topical AKP-11 for the Treatment of Atopic Dermatitis (Eczema)

AKP-11 demonstrated efficacy, safety and tolerability in Phase-1. AKP-11 offers new potential topical treatment of moderate-to-severe atopic dermatitis.

MELBOURNE, VICTORIA, AUSTRALIA , August 4, 2017 / -- Akaal Pharma Pty Ltd, an Australian clinical-stage biopharmaceutical company focused on developing new small molecule drugs for the treatment of inflammatory and immune diseases, today announced the start of Phase-2 clinical trial of AKP-11, a novel and First-in-Class topical treatment for atopic dermatitis, a form of eczema. Topical application of the investigational drug AKP-11 to atopic dermatitis patients in a 4-week Phase-1 clinical study was found to be safe, well tolerated and effectively reduced eczema severity and eczema area. There exists an underserved need for safer and effective topical agents for the treatment of moderate-to-severe atopic dermatitis. The results from the Phase-1 clinical studies of AKP-11 are very encouraging. Based on these positive Phase-1 clinical trial results, we have initiated dosing in Phase-2 clinical trial for the topical treatment of patients with mild-to-severe atopic dermatitis lesions, said Dale Dhanoa, CEO of Akaal Pharma. We are pleased about achieving this milestone closer to developing a novel and innovative treatment option for patients suffering from this chronic pruritic inflammatory dermatological condition.
About Atopic Dermatitis: Atopic dermatitis is a chronic skin disease with inflammation and itch that afflicts millions of children and adults worldwide. The disease is associated with sleep loss and a significant reduction in quality of life and has no known cure. The current treatments suffer from local and systemic side effects such as skin atrophy and others. A safe and effective treatment is needed to treat moderate-to-severe form of this condition.
About AKP-11: AKP-11 is a novel, potent and selective sphingosine-1-phosphate-receptor-subtype-1 (S1P1) modulator that acts via multiple mechanisms to significantly reduce the overexpression of several pro- inflammatory cytokines and factors that play crucial role in the pathology of atopic dermatitis. The novel S1P1 receptor modulator AKP-11, is also undergoing its Phase-2 clinical trial for the topical treatment of plaque psoriasis, a serious chronic skin disease
About Akaal Pharma: Akaal Pharma is a clinical-stage company focused on advancing the clinical development of its internally discovered topical and oral small molecule drug candidates for treating inflammatory and immune diseases specifically atopic dermatitis, psoriasis, arthritis, pain, multiple sclerosis, ulcerative colitis and other diseases. For more information, visit
Contact: Akaal Pharma Pty Ltd, Thomas Cherry Building, #301E, La Trobe University, Bundoora, VIC-3083, Australia. Tel: +61-3-9479-2584. Email:

Certain statements in this new release concerning Akaal Pharma Pty Ltd) business are considered “forward looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, those relating to the timing and results of future clinical development of AKP-11, the expected safety, tolerability and potential efficacy of AKP-11 as compared to other drugs treating atopic dermatitis, psoriasis and other conditions. Any or all the forward-looking statements in this press release can be affected by inaccurate assumptions Akaal Pharma might make or by known or unknown risks and uncertainties, including, but not limited to: the early stage of drug development; uncertainties as to the future success of ongoing and planned clinical trials; and the unproven safety and efficacy of drugs (products) under development. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Akaal Pharma Pty Ltd (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.

Dale Dhanoa
Akaal Pharma Pty Ltd
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