An article from Tim Boreham (Biotech Daily) on 5th Nov 2021.
https://www.biotechdaily.com.au/media/Dr%20Boreham/ANP_Nov_5_2021.pdf
The European Medicines Agency in effect approved the company’s Paediatric Investigation Plan, a blueprint for how the company would develop its Duchenne muscular dystrophy drug on the Continent.
“This study could turn out to be a pivotal trial,” says Antisense chief executive Mark Diamond.
“In other words, if we get the requisite data showing significant clinical improvement in upper limb function, we could submit for European approval.”
Doesn’t Sarepta thus have the market covered already? Not so, says Mr Diamond.
The three drugs each pertain to a form of genetic mutation and, collectively, cover only 25 percent of DMD patients. They also have a different mechanism of action.
Mr Diamond says ATL1102 potentially could be used in conjunction with Sarepta’s therapies, to treat both ambulant and non-ambulant boys.
He adds that Sarepta won FDA approval without showing improvement in disease progression in controlled, randomized studies.
Instead, the FDA was convinced by an improvement in dystrophin levels in the boys’ muscles. Sarepta was knocked back by the European regulator, which won’t accept such surrogate endpoints. ----- In any event, Antisense is well positioned to keep an eye on the competition...
Antisense has some other tricks up its sleeve to reduce fibrosis in other human diseases, including a recently-inked collaboration with the Murdoch Children’s Research Institute (at the RCH) on other rare inflammatory disorders.
"behind the scenes there’s real progress at Antisense....What’s clear is that after two decades in the chair, Mr Diamond isn’t about to throw in the towel. ....And if the European trial founders, it won’t be for lack of cash."
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