MELBOURNE, Australia and SAN DIEGO, CA, USA, Jan 29, 2015. Akaal Pharma Pty Ltd,
(Akaal Pharma), an Australian clinical-stage biopharmaceutical company focused on
developing new small molecule drugs for the treatment of inflammatory and autoimmune
diseases, today announced the positive results from a randomized, double-blind, placebo-controlled Phase-1 clinical trial of AKP-11, a novel and First-in-Class topical Sphingosine 1-
Phosphate receptor-1 (S1P1) modulator for the treatment of mild-to-moderate plaque
psoriasis. In this study, the topical application of AKP-11 to psoriasis patients for 28 days
was found to be safe, well tolerated and resulted in a significant reduction in plaque severity.
No detectable plasma levels of AKP-11 were found in the pharmacokinetic analysis, which is
attributable to the large therapeutic index of AKP-11.
“Although a variety of therapies are available for treating psoriasis, there exists an
underserved need for safer and effective topical treatments for long-term use. The Phase 1
clinical data for AKP-11, a topical First-in-Class S1P1 modulator, is very encouraging and
strongly supports our Phase 2 clinical trial in a larger number of patients,” said Dale Dhanoa,
Ph.D., CEO of Akaal Pharma.
Study Details
The Phase 1 clinical trial was a randomized, double-blind, and placebo-controlled study that
involved 16 subjects. This study was conducted in 2 parts, Phase 1A and Phase 1B. AKP-11
or placebo were administered as an ointment to 4 healthy subjects in PART A and extended
to 12 psoriasis patients in PART B. The patients were treated once daily with a topical
application of AKP-11 for 28 consecutive days. AKP-11 reduced the local psoriasis severity
index (LPSI) and demonstrated significant efficacy when compared to baseline (p=0.0016).
The placebo group did not show efficacy. No clinically significant local or systemic adverse
events were observed in the study.
About AKP-11
AKP-11 is a novel, potent and highly selective sphingosine 1-phosphate receptor subtype-1
(S1P1) modulator undergoing clinical development for topical treatment of psoriasis and
other skin diseases. AKP-11, a novel small molecule, has also shown excellent preclinical
pharmacokinetic and pharmacodynamics profile as a potential Best-in-Class oral treatment
for autoimmune indications. AKP-11 acts via multimodal actions and significantly reducesthe overexpression of pro-inflammatory cytokines and factors including the permeability
factor VEGF.
About Psoriasis
Psoriasis is one of the most widespread autoimmune/inflammatory skin disorders affecting
more than 2% of the global population, with no known cure. Psoriasis is a chronic disease
that requires long-term treatment. Nearly 80% of patients have mild to moderate psoriasis.
The disease is characterized by the presence of red, scaly patches known as psoriatic
plaques, which are inflamed and produce excessive skin-cells. Psoriasis and other
inflammatory skin disorders are characterized by marked infiltration of leukocytes into the
dermis and epidermis, oedema, vascular leak, severe hyperplasia and inflammatory cytokine
up-regulation. The current treatments suffer from known local and systemic side effects such
as skin atrophy and others.
About Akaal
Akaal Pharma Pty Ltd (Akaal Pharma) is a clinical-stage drug discovery and development
company focused on the development of novel small molecule drugs for the treatment of
inflammatory and autoimmune diseases including psoriasis, atopic dermatitis, multiple
sclerosis, ulcerative colitis, and rheumatoid arthritis. Akaal Pharma has created a robust
pipeline of novel, potent, and highly selective S1P1 receptor modulators that have shown an
excellent oral and topical drug profile. Akaal Pharma applies its medicinal chemistry and
drug discovery platform to discover and develop novel, safer and highly effective topical and
oral drugs for the treatment of inflammation and immune diseases with unmet or undermet
need. For more information, visit www.akaalpharma.com.
Contact
Dale Dhanoa, Ph.D., Chief Executive Officer
Akaal Pharma Pty Ltd, Thomas Cherry Building, # 301E
La Trobe University, Bundoora, VIC-3086, Australia
Direct: +1 858 925-4555 (San Diego, CA, USA)
Tel. +61 3 9479 2584 (Melbourne, Australia)
[email protected]