US-based drug-development company Arrien Pharmaceuticals has begun its Phase I clinical trial of ARN-6039 to treat relapse, remitting, and progressive multiple sclerosis (MS), an autoimmune neuroinflammatory demyelinating disease of the central nervous system.
ARN-6039 is a small molecule inverse-agonist that targets the ROR-?t, which is an important transcription factor and the sole controller of human TH17 (T helper 17) cells.
Approved by the US Food and Drug Administration (FDA) and under the Investigational New Drug (IND) application, the company is carrying out the Phase I programme.
The single-centre, randomised, double-blind placebo-controlled safety, tolerability, and pharmacokinetic (PK) trial is designed to assess the effect of single ascending oral doses of ARN-6039 when administered to healthy adult subjects.
MS affects the fatty myelin sheaths surrounding the axons of the brain and spinal cord while damaging and scarring the myelin sheaths (sclerosis or plaques), resulting in a wide range of symptoms.
The ROR-?t regulates cellular differentiation, function, and IL-17 release by TH17 cells and mediates the immunopathology of human autoimmune diseases such as multiple sclerosis (MS), psoriasis, rheumatoid arthritis (RA), inflammatory colitis, COPD, and asthma.
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Arrien Pharmaceuticals SAB member and University of Utah school neuroimmunology division chief John Rose said: "Recent clinical success of IL-17 / TH17 / ROR targeting agents and oral dosage form, brain-uptake, excellent safety, and efficacy characteristics in models systems, are important aspects of ARN-6039 as potentially innovative new therapy for the treatment of multiple sclerosis."
Around 50 healthy human subjects will be enrolled in the Phase I programme, and the company expects to take the programme forward through Phase II proof of efficacy studies in MS patients at the end of the year.
The company is also exploring the scopes of administering ARN-6039 in other immune-mediated disorders such as psoriasis to leverage on the drug’s full potential.