AOD9604 awarded safe status in US

Calzada (ASX:CZD) subsidiary Metabolic Pharmaceuticals has announced that its peptide AOD9604 has been designated Generally Recognised As Safe (GRAS) in the US.

GRAS status will allow the use of the peptide as an ingredient in foods, drinks and dietary supplements at the daily level of up to 1 mg per person, without requiring further pre-market approvals.

AOD9604 is a modified fragment of human growth hormone first developed as an anti-obesity drug. The compound attracted attention in Australia after it was alleged that Essendon AFL players were taking the drug to build muscle mass.

Anti-doping authority ASADA had threatened to pursue athletes over their use of the drug even though it was a banned substance by virtue of not being approved for human use. But the authority subsequently decided not to continue investigations.

“The GRAS status for AOD964 might make Metabolic’s IP an attractive target for supplement, ingredient and neutraceutical companies,” Calzada chairman David Williams said.

He said the company is considering alternative ways of extracting value from the peptide, including licences, trade sale or spinning the business into a separate listed entity.

In the last year, Metabolic has already entered into non-exclusive licences with two Australian compounding pharmacies covering the use, manufacture and sale of the peptide in compounded medicines that comply with Australian regulatory requirements.

Calzada (ASX:CZD) shares were trading unchanged at $0.120 as of around 2:30 pm on Wednesday.