Alteogen Inc. announced that their recently concluded clinical trial of Tergase® showed zero incidence of ADA (including neutralizing antibodies). Tergase® is Alteogen's first proprietary product currently under pharmaceutical approval process by the Korean Ministry of Food and Drug Safety. Tergase® is a stand-alone hyaluronidase product that can be used for the treatment of various medical conditions, such as pain relief, edema treatment, and hyaluronic acid filler removal.

In particular, compared to commercially available animal-derived hyaluronidase products in the market, it is a highly purified product of high-quality with very few impurities and an excellent side effect profile. As a Novel Recombinant Human Hyaluronidase, Alteogen expects that Tergase® will be applicable to new indications which are currently not available to existing animal-derived products. The presence of ADA is known to induce unwanted side effects.

Therefore, regulatory authorities have very closely scrutinized products for the presence of ADA, using data from immunogenicity safety studies. ADA are also intimately related to drug efficacy and duration of drug action. As Tergase® is a genetically modified human recombinant protein generated by domain swapping technology between two subtypes of human hyaluronidases, the low incidence of ADA was expected.

Thus, Alteogen believes the outcome of zero ADA incidence in the clinical trial with 244 healthy volunteers make Tergase® a highly competitive product in the market due to its high quality.