OptiBiotix Health PLC’s (LON:OPTI) LPLDL probiotic has been granted ‘generally recognised as safe’ (GRAS) status by the US Food and Drug Administration (FDA).
The maker of weight management products said its subsidiary, ProBiotix Health Ltd, had received the GRAS after completing process validation under pharmaceutical good manufacturing practices (GMP), which test whether a drug substance such as LPLDL is produced consistently at pharmaceutical grade quality.
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GRAS is the highest level of food safety certification in the US, while OptiBiotix said the GMP validation was a “significant step” in developing LPLDL as a pharmaceutical drug product.
The company also said achieving the GMP was linked to a milestone payment from a licensing deal with a US company announced last year.
"Completing Pharmaceutical GMP process validation and receiving the GRAS notification letter from the US FDA is a significant achievement for ProBiotix and LPLDL,” said ProBiotix chief executive Steve Prescott.
He added that the GRAS and GMP status would increase the “market attractiveness” of LPLDL and that “few marketed probiotics have achieved this level of proven safety and efficacy”.