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 characterised 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.
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 commercialisation plans for this exciting new therapeutic to treat MS.”
Source: Multiple Sclerosis News T oday © Copyright 2014 BioNews Services, LLC (29/10/14)
Antisense Therapeutics reports the publication of previously generated Phase IIa clinical trial data on ATL1102 in the medical journal Neurology.
The article titled “CD49d antisense drug ATL1102 reduces disease activity in patients with relapsing-remitting MS”, is currently available online and will be included in the print edition Volume 83, November 11, 2014.
The article highlights the successful outcomes of the Phase IIa clinical trial of ATL1102 in Multiple Sclerosis (MS) patients where in the randomised, double-blind, placebo-controlled study in 77 patients with relapsing-remitting multiple sclerosis (RRMS), ATL1102 met its primary end point after only two months of dosing, showing a significant reduction, by 54.4% (p=0.01) in the cumulative number of new active brain lesions in patients taking ATL1102 compared to placebo.
The efficacy outcomes from this study were viewed to be as good as, or superior to, those achieved with MS drug Tysabri® at a similar stage in its clinical development. Tysabri® (natalizumab) is a monoclonal antibody drug targeting the VLA-4 receptor (same target as ATL1102). In 2013, Tysabri® generated sales in excess of US$1.6 billion. It is regarded as the current efficacy benchmark for the treatment of RRMS. ANP anticipates that ATL1102 could be as potent as Tysabri® but potentially safer, cheaper to manufacture, and more conveniently dosed.
Principal Investigator of the ATL1102 Phase IIa study and lead author of the Neurology publication, Volker Limmroth (MD PhD Professor of Neurology, Chairman Department of Neurology and Palliative Care Medicine Cologne City Hospitals, University of Cologne) said:
There are a number of unresolved issues with current MS drugs including the occurrence of neutralising antibodies to the antibody, protein and peptide MS drugs as well as long-term safety concerns with the more recently approved drugs. There is a clear need for more effective and safe drugs for the significant population of MS patients who have relapses and non-stable disease.
The ATL1102 Phase IIa trial provides evidence for the first time that antisense oligonucleotides may be used as a therapeutic approach in neuroimmunologic disorders such as MS. ATL1102 was shown to be highly effective in reducing brain lesions in RRMS patients with a quick onset of action and a clinical safety profile that strongly supports its ongoing development as a treatment for this disease.
The full article can be downloaded from http://www.neurology.org/content/early/recent
Antisense Therapeutics CEO and Managing Director Mark Diamond said:
The Journal of the American Academy of Neurology is the most widely read and highly cited peer-reviewed Neurology Journal. Having our ATL1102 Phase II data published in such a high quality scientific journal is extremely beneficial for the future development and partnering plans for the drug and our current FDA interactions. It also provides further independent validation to the quality of our data and considerable development progress made by the Company in advancing ATL1102.
Source: News-Medical.Net Copyright 2000-2014 AZoM.com Limited (22/09/14)
Antisense Therapeutics Limited (“ANP” or the “Company”) is pleased to advise that results from a chronic toxicity study in monkeys indicate that ATL1102, an antisense oligonucleotide currently under development for the treatment of multiple sclerosis (MS), was well-tolerated when given subcutaneously for a 6-month dosing period at the 2 dose levels tested (1.5 and 3mg/kg/dose). The Company believes that the preclinical and clinical experience to date with ATL1102 should allow dosing in future trials at or above the 1.5 mg/kg/dose level.
Based on histologic findings in common with a previous monkey study at doses exceeding 1.5mg/kg/dose, the Company continues to evaluate the chronic monkey data with regard to potential human relevance, and safety biomarkers that may be useful in future clinical studies. Exposures achieved in this study are regarded as potentially clinically relevant based on the efficacy outcomes from the previously conducted Phase IIa trial of ATL1102 in MS patients.
Pending receipt and final data evaluation from the current study, as well as review of all the preclinical and clinical data obtained, ANP is planning future regulatory agency discussions regarding further development of ATL1102 and the dosing regimen for a future Phase IIb trial in MS patients. The Company anticipates final review of the data by June this-year and follow-up discussions with the US Food and Drug Administration (FDA) at a pre-IND meeting during the 3rd quarter 2014.
Antisense Therapeutics CEO and Managing Director Mark Diamond said “The results of this most recent toxicology study and the human data to date are encouraging and re-ignite our hopes for this project. We are continuing to generate new data on ATL1102 which we believe will support positive interactions with the FDA in relation to our plans for a future Phase IIb trial in MS patients. We look forward to confirming our plans for the further clinical development of ATL1102 with the FDA in the coming months.”
Source: www.news-medical.net/ (02/04/14)