Antisense Therapeutics Limited (ASX: ANP) is an ASX listed biopharmaceutical company, which is aiming to develop and commercialise antisense pharmaceuticals, for the huge untouched markets. Also, Ionis Pharmaceuticals Inc. which is based in the US and is the world leader in antisense drug development and commercialisation is licensing ANP’s products.
On 4th April 2019, the company provided an update about its ongoing Phase II clinical study of ATL1102 for Duchenne Muscular Dystrophy (DMD). Out of 9 patients’ requirement for trial of immunomodulatory therapy, the company has enrolled 7 so far.
DMD is an X-linked disease which occurs because of transformations in the dystrophin gene, which causes a substantial reduction in the dystrophin protein. The disease affects 1 in 3600-6000 live male births. Children with DMD are prone to contraction-induced injury due to dystrophin-deficient muscles, which worsen the muscle damage. If there is no intervention, the average age of a person’s life, suffering from the disease is approximately 19 years.
Regarding the Phase II clinical trial update, the company mentioned that it is being conducted at the Neuromuscular centre of the Royal Children’s Hospital (RCH), Melbourne in 9 non-ambulant patients, having DMD aged between 10 and 18 years. The open-label dosing trial of ATL1102 (duration of half a year), is given to all the 9 patients. Out of which, five patients are in the treatment phase of the study. Also, one patient has completed the dosing with the two months monitoring period, and the seventh patient is about to commence the dosing. For the nine-patient study, the final two patients are expected to be enrolled into the trial this month, subject to meeting the eligibility criteria.
ATL1102 is an antisense inhibitor of CD49d expression on T- cells. There is a high chance of rapid and more severe disease progression in patients with DMD, who are having a greater number of T cells, with high levels of CD49d on their surface, according to the Scientific literature. Currently, there are a very limited number of anti-inflammatory drugs for DMD. ATL1102 is the only CD49d targeting drug going through the clinical trials in DMD patients, in the world.
The endpoints of the trial would be related to the tolerability and safety of ATL1102. The effectiveness of ATL1102 will also be judged, in terms of how it is affecting muscle damage, markers of inflammation and disease progression. The effectiveness of the endpoints will be judged, as changes from a patient’s baseline measurements, to the same measurements at the completion of their dosing.
CEO of Antisense Therapeutics, Mark Diamond is very pleased with the progress of Phase II clinical trial of ATL1102. There have been no serious adverse events reported to date, and the clinical trial database continues to grow with data, on the longer-term patient exposure to ATL1102.
On 18th January 2019, the company announced the Phase II clinical trial for DMD.
The stock fell by 5% and closed at A$0.038 as of 4th April 2019 compared to the previous closing of A$0.040. The stock has given a good rally in the last six months, yielding a return of approx. 122%. The YTD return of the stock stands at 53.85%.
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