Akaal Pharma's AKP-11 meets or surpasses MS drug Gilenya in animal model of disease

Akaal Pharma, a developer of small molecule drugs for the treatment of inflammation and autoimmune diseases including multiple sclerosis (MS), recently announced highly positive preclinical trial results on the safety and efficacy of its drug candidate AKP-11 when compared to Gilenya (fingolimod, FTY-720), an oral MS drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsing forms of the disease.

The results were published in the journal PLOS One, under the title “AKP-11 – A Novel S1P1 Agonist with Favorable Safety Profile Attenuates Experimental Autoimmune Encephalomyelitis in Rat Model of Multiple Sclerosis.”

AKP-11 is a potent and highly selective modulator of spingosine-1-phosphate receptor-1 (S1P1), which has been implicated in inflammatory diseases such as MS and rheumatoid arthritis.  According to Akaal Pharma, AKP-11 is a highly metabolically stable drug candidate with an excellent drug profile, a short half-life, good oral bioavailability, and a high volume of distribution and clearance. AKP-11 acts through several mechanisms, including the reduction of the overexpression of pro-inflammatory cytokines.

Researchers evaluated the safety and efficacy of AKP-11 both in vitro in cell culture and in vivo with an animal model of experimental autoimmune encephalomyelitis (EAE), a rat model of human MS. The team found that treatment with AKP-11 or Gilenya had a similar efficacy and provided comparable neuroprotection in the EAE animals.

In terms of safety, AKP-11 treatment induced milder and reversible lymphopenia (abnormal low levels of lymphocytes, important immune system white blood cells) compared to Gilenya, which caused a severe and long-lasting lymphopenia in the EAE animals. AKP-11 also exhibited a greater safety profile on adverse effects such as heart rate and lung vasculature, suggesting that AKP-11 might be a safer drug than Gilenya.

“The excellent drug profile of AKP-11 strongly supports its ongoing clinical development for the treatment of autoimmune and inflammatory diseases. AKP-11 is potentially a Best-in-Class oral drug for the treatment of multiple sclerosis, psoriasis, ulcerative colitis and other autoimmune and inflammatory diseases,” concluded Dr. Dale Dhanoa, CEO of Akaal Pharma in a press release.

Akaal Pharma is now planning to test AKP-11 in Phase I clinical trials as a therapy for MS and other autoimmune diseases.