Experimental Multiple Sclerosis Drug Clears Key FDA Hurdle, To Be Tested in U.S.

A new human clinical trial testing the drug ATL1102 to treat Multiple Sclerosis was approved by FDA, carrying the promise of new therapeutics to affected patients.

Antisense Therapeutics Limited (ANP) announced recently in a press release the FDA’s positive decision to approve their request to submit an Investigational New Drug (IND) application in the U.S. This decision allows ANP to initiate a long-term Phase IIb clinical trial for the treatment of Multiple Sclerosis (MS) with ATL1102.

ANP is currently looking for a pharmaceutical partner for the ATL1102 program development.

Multiple sclerosis (MS) is an autoimmune disease that affects the central nervous system. Currently without a cure, MS affects more than 2.3 million people worldwide, 300,000 to 400,000 of whom live in the United States alone. The disease is characterized by destruction of myelin layer within nerve cells, probably caused by a hyper-reactive immune system, with accumulation of white blood cells (leukocytes) in the central nervous system. This leads to a wide range of neurological symptoms affecting visual, motor, and sensory capabilities.

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ATL1102 is an antisense inhibitor (belonging to the second generation of inhibitors) of CD49d, a subunit of VLA-4 (Very Late Antigen-4) and a key player regulating immune cell recruitment to inflamed endothelia and other sites of inflammation. Thus, inhibiting VLA-4 potentially prevent leukocytes recruitment, delaying disease progression. VLA-4 is a clinically validated target in the treatment of MS.

ANP showed previously that ATL1102 effectively reduced MS lesions in a Phase II clinical trial in patients with relapsing-remitting multiple sclerosis (RRMS), with superior results when compared to Tysabri® (natalizumab), a monoclonal antibody drug to the VLA-4 receptor. While Tysabri® was reported to cause a potential lethal viral brain infection (progressive multi focal leukoencephalopathy, PML), ATL1102 was safer and equally effective.

Antisense Therapeutics’ CEO and Managing Director Mark Diamond commented, “The FDA Response is an excellent outcome and important step in moving ATL1102 forward into late-stage clinical development and to capitalize on the substantial development and investment made to date on this key project asset. We look forward to providing further updates as we advance development and commercialization plans for this exciting new therapeutic to treat MS.”