Alteogen's Tergase® Demonstrates Superior Immunogenicity Characteristics

Korean biotech firm Alteogen Inc. has publicized the findings of their most recent Tergase® clinical study, wherein no occurrence of ADA (inclusive of neutralizing antibodies) was found. An application for official approval of Tergase®, the premier proprietary drug developed by Alteogen, is currently under review by the Korean Ministry of Food and Drug Safety.

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As a unique hyaluronidase product, Tergase® can be utilized in managing diverse medical conditions such as pain management, edema control, and hyaluronic acid filler extraction. It stands out as an exceptionally purified product, housing minimal contaminants with an impressive side effect record, compared to the familiar animal-originated hyaluronidase products retailed. As a pioneering Recombinant Human Hyaluronidase, Alteogen anticipates that Tergase® may be relevant to new applications not yet explored with existing animal-derived products.

Antibody Drug Antibodies (ADA) have been linked to undesired side effects, making regulatory bodies stringent in inspecting products for ADA presence. The influence of ADA on drug effectiveness and the duration of drug activity is also notable. Alteogen hence considers the absence of ADA during the clinical trial involving 244 healthy individuals a significant advantage, enhancing Tergase®’s competitiveness due to its superior quality.

CEO of Alteogen, Dr. Soon Jae Park emphasized the high demand for innovative products in the market, focusing on stability and safety, as the typical animal-derived products carry limitations for extensive use due to their side effect profiles. Tergase®, in comparison with its sole commercial competitor's human recombinant hyaluronidase, possesses potential superiority in several areas. Dr. Park projects this could result in an influential gain in market share across multiple fields.

Past research indicated an ADA incidence of 3~12% in the competitor's recombinant hyaluronidase product. More noteworthy is the significant reduction in Injection Site Reactions (ISR) with a 4~20 times higher dose of Tergase® compared to the competitor’s product dose.

Tergase® is at present in the pharmaceutical approval stage overseen by the Ministry of Food and Drug Safety. Product approval is anticipated to transpire between late 2023 and early 2024 at the latest, contingent on the schedule for additional supplementary data requirement.

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According to the data provided by the Synapse Database, As of September 7, 2023, there are 4 investigational drugs for the Hyaluronidase target, including 2 applicable indications,4 R&D institutions involved, and as many as 8034 patents.

Alteogen, Inc. is pioneering the production of an enzyme-oriented medication named ALT-BB4, which is engineered to influence hyaluronidase. Currently, this drug is in its initial phase - Phase 1 clinical examination implying it's still in the preliminary stages. Subsequent investigations and evaluations are essential to ascertain the probable therapeutic uses and effectiveness of ALT-BB4 in biomedical science.