On Friday, Antisense Therapeutics Limited (ASX: ANP) announced that Phase II clinical trial of its immunomodulatory therapy, ATL1102 for Duchenne Muscular Dystrophy (DMD) is now fully enrolled. The trial is an open-label six-month dosage trial and is being carried out at the neuromuscular centre of the Royal Children’s Hospital in Melbourne. It comprises nine non-ambulant patients with DMD aged between 10 to 18 years.
It is reported that three patients completed their 24 weeks of dosing and final two patients would be dosed this month while four patients are in treatment phase already. Dosing is expected to be completed by early November 2019 and so far, no adverse events have been noticed, as per the report.
DMD patients suffer inflammation that exacerbates muscle fibre damage and ATL1102 is getting developed as a novel treatment for this cause. Currently, Corticosteroids is used as a standard treatment for DMD patients, which poses serious side effects when used for a prolonged period as necessary in DMD. As of now, there are a limited number of drugs for anti-inflammatory treatment used in DMD which are clinically active.
Primary endpoints of the trial relate to the safety and tolerability of ATL1102 and effectiveness of the drug would be assessed in terms of its disease process and progression. The extended dosing period (24 weeks) of the trail may provide an opportunity to reflect of an improvement in the clinical endpoints, these clinical endpoints are important to DMD disease progression like upper limb function of the boys and would be required for future product registration. Past published studies for non-ambulant DMD boys also reflect a significant decline in such functional endpoint even if the patients are on corticosteroids. One of the objectives of ATL1102 trial is to address the decline in the upper limb strength and function of the non-ambulant DMD patients
ATL1102 for DMD (Company’s Presentation, January 2019)
ANP expects to report the result of the trial shortly after the completion of dosing. The company stated that there would be an opportunity for non-statistical study read outs on preliminary data before the scheduled dosing of the drug is completed as Phase II DMD clinical trial is an open-label study. However, this is subject to completion of dosing period for sufficient patients which would place certainty on the robustness of such results for disclosure.
Mark Diamond, CEO of Antisense Therapeutics, mentioned the achievement of full enrolment into the Phase II clinical trial of ATL1102 in DMD patients and appreciated the efforts of patients and families in frequent visits to hospitals while bounded by wheelchair. He said in order to maintain the safety of trial, Data Safety Monitoring Board carries a continuous evaluation and no exception has been recorded as of now with respect to safety. Additionally, ANC expects to report results in the fourth quarter this year.
Antisense Therapeutics Limited is an Australian publicly listed company on ASX. ANC develops and commercialises antisense pharmaceuticals for large unmet markets. Products by ANC are licensed to a world leader in antisense drug development and commercialisation - Ionis Pharmaceuticals Inc.
ANP last traded at $0.053, up 6%, on 24 May 2019. The market capitalisation of ANP stands at approximately 21.01 million and year to date returns is +92.31%.
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