- Five patients have completed Antisense’s Phase II 24 week treatment period for the use of ATL1102 in Duchenne Muscular Dystrophy
- No serious side effects have been reported so far
- Other medication such as corticosteroids can cause various side effects – Antisense is trying to ensure ATL1102 will be as safe and tolerable for patients
- Dosing of the remaining four patients is on track and expected to be completed in early November 2019
Antisense Therapeutics has advised that five patients have completed their 24 week dosing program in the Phase II clinical trial of the Antisense’s immunomodulatory therapy, ATL1102, for Duchenne Muscular Dystrophy (DMD).
The remaining four patients are at various stages within their treatments and dosing is expected to be completed in early November 2019.
The Data Safety Monitoring Board have been periodically evaluating the safety related trial data and have, so far, noted no serious side effects.
Antisense CEO Mark Diamond is pleased with the results and hopes the treatment can be rolled out soon.
“We are pleased to have more than half of patients in the trial having completed dosing with no SAE’s (serious adverse effects) reported to date and to be on track for completion of the treatment phase of the trial in the next quarter,” he said.
The six month dosing trial of ATL1102 was administered to patients aged between 10 and 18 with DMD, and is being completed at the neuromuscular centre at the Royal Children’s Hospital in Melbourne.
DMD is an X-chromosome disease that effects one in 3600 to 6000 male births. It occurs as a result of a mutation in the dystrophin gene (protein found in skeletal muscles and also the heart muscle). This then causes a substantial reduction or absence of the dystrophin protein.
Ongoing deterioration in the muscles can cause muscle weakness and often affects the lower and upper limbs resulting in impaired ability, loss of function and loss of self-caring ability.
There are currently no cures but medications such as corticosteroids and ongoing therapy can help control the symptoms and improve the patient’s quality of life.
ATL1102 is being developed as a novel treatment for the inflammation and muscle fibre damage in DMD patients who are currently being treated with corticosteroids, these are anti-inflammatory medicines that are provided to a range of conditions.
However, they have a range of side effects when used for a prolonged period of time such as the treatment of DMD. Some side effects include weight gain, diabetes, high blood pressure, weak and brittle bones, and mood swings which can lead to depression.
The main goal of this trial is to make sure ATL1102 is tolerable and as safe as possible. It will also be assessed in terms of effectiveness on disease process and progression.
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