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- Antisense Therapeutics (ANP) is set to conduct a nine-month chronic monkey toxicology study in the US to progress its Duchenne muscular dystrophy drug, ATL1102
- The study is the final step required for lifting ANP’s partial clinical hold that limits ATL1102 dosing to 25 milligrams per week for six months in the US, though the company has had difficulties pursuing the study due to a shortage of appropriate monkeys
- However, a customer of ANP’s study partner, Pharmaron, recently cancelled a similar study, making the pre-selected monkeys available
- Antisense now plans to begin dosing all monkeys as part of the study before the end of this year
- Shares in Antisense are up five per cent and trading at 10.5 cents at 1:05 pm AEDT
Antisense Therapeutics (ANP) is set to conduct a nine-month chronic monkey toxicology study in the US to progress its Duchenne muscular dystrophy drug, ATL1102.
The company has initiated the process, with Contact Research Organisation (CRO) Pharmaron to support the program.
The study is the final step required for lifting ANP’s partial clinical hold that limits ATL1102 dosing to 25 milligrams per week for six months in the US.
This would allow Antisense to apply for an expedited program status with the US Food and Drug Administration (FDA), including Fast Track or potential Breakthrough
Therapy designation.
“The commencement of a chronic toxicology study that aligns with FDA requirements is an important advancement for the ATL1102 program and a key value-adding catalyst,” ANP Chair Charmaine Gittleson said.
“Importantly, it provides the company the prospect of sharing with FDA a compelling data package encompassing the clinical results from the placebo-controlled six-month study along with the outcome of the nine-month toxicology study,” Dr Gittleson said.
“The next calendar year is presenting as an exciting time for the company and the DMD community as we commence these potentially transformative activities.”
The company initially had difficulties pursuing the study due to a shortage of appropriate monkeys. However, a customer of study partner Pharmaron recently cancelled a similar study, making the pre-selected monkeys available.
To take advantage of this opportunity, Antisense has taken on the costs of the pre-allocated animals while completing the necessary arrangements with the CRO.
This has enabled Pharmaron to initiate the company’s study, with the dosing of all animals to commence before the end of this calendar year and the reporting of key study findings expected in the first half of 2024.
This is around the same time as six-month dosing results from Antisense’s ATL1102 in DMD Phase 2b clinical study are expected.
Shares in Antares in Antisense are up five per cent and trading at 10.5 cents at 1:05 pm AEDT.
