Alzheimer’s Decision Sends Positive Message to Aussie...

Alzheimer’s Decision Sends Positive Message to Aussie Biotechs

This is from Dr.G. Price Point of view:


A prominent US physician and consultant to Antisense Therapeutics (ASX:ANP), Dr Gil Price notes the FDA’s approval was based on complex data set. That being the case, Biogen will conduct a controlled trial for the verification of Aduhelm clinical benefit in patients with AD.

“But if Antisense Therapeutics produces similar data, we would expect a similar decision from FDA,” says Price, a former director of the Nasdaq-listed Duchenne muscular dystrophy (DMD) drug developer Sarepta Therapeutics.

Antisense is is planning to pursue FDA “fast track” designation for its DMD drug candidate ATL1102. DMD is an incurable muscle wasting disorder that affects one in every 3600 to 6000 male children.

The company is currently discussing the construct of a proposed phase 2b/3 trial with the FDA.

However Price says the FDA’s decision does not constitute a lowering of standards. “The FDA reviewed data in a very difficult therapeutic area, and made a reasonable decision that offers patients hope,” he says.

“Keep in mind that FDA has been working with Biogen over the past 10 years as a partner, more than an overseer.“

Antisense Therapeutics appreciates the culture at FDA for the development of drugs that treat rare diseases and hopes to build a similar relationship as we continue to move forward.”