Antisense Phase II Clinical Trial now 50% enrolled and on track for completion
Antisense Therapeutics (ASX:ANP) has provided a highly promising update on its Phase II clinical trial of its immunomodulatory therapy, ATL1102 for Duchenne Muscular Dystrophy (DMD).
The company has indicated that five patients are now enrolled in the nine patient trial, with four of these now being dosed with ANP’s ATL1102 treatment. The fifth patient has recently passed the eligibility criteria, and will commence their dosing schedule in early February.
No serious adverse events or affects have been reported to date during the trial, which is being conducted at the neuromuscular centre of the Royal Children’s Hospital in Melbourne (RCH) (which operates the largest DMD treatment clinic in the southern hemisphere).
ATL1102 is an inhibitor of CD49d expression on certain immune cells (T cells). Scientific literature has reported that patients who possess a greater number of T cells with high levels of CD49d on their surface, experience more severe and rapid disease progression.
ATL1102 is being developed as a novel treatment for the inflammation that exacerbates muscle fibre damage in DMD patients, currently treated with corticosteroids. Unfortunately, corticosteroids have a range of serious side effects when used for extended periods, which is required in DMD patients.
The main objective of the trial pertain to the safety and tolerability of ATL1102, with the effectiveness of its ability to reduce inflammation, muscle damage and disease progression to also be assessed.
ANP remains on track to have nine patients enrolled into the trial and have their dosing complete in Q3 2019. Trial results will follow, however earlier study read outs are possible (because the trial is an open label study).
US based DMD group Parent Project Muscular Dystrophy (PPMD), whose advocacy efforts have secured hundreds of millions of dollars in funding and secured two FDA approvals, have incorporated details on the ATL1102 for DMD trial on their website (which can be found below).
PPMD’s efforts are focused on advancing care and treatments for DMD by leveraging US federal resources, building partnerships and creating regulatory procedures and infrastructure.
Since its inception in 2000, PPMD has invested over US$50 million into DMD research and therapy development and aid in leveraging over US$500 million dedicated for DMD.
ANP CEO Mark Diamond spoke on the clinical trial update, “We are very pleased to see the ATL1102 listing by PPMD, the most prominent US DMD advocacy group, as it significantly increases visibility and awareness of ANP’s DMD clinical development activities in the US, the world’s largest pharmaceutical market.”