TaiMed Biologics Inc (中裕新藥) yesterday said it is to start phase I clinical trials for TMB-607, a protease inhibitor for treating HIV-1, in the third quarter of this year after gaining new drug approval from the US Food and Drug Administration (FDA) on Thursday.
The company said phase I clinical trials are expected to begin in August, following two to three months of preparations, and that it is eligible for a US$100,000 milestone payment from its licensing partner, Ambrilia Biopharma Inc, once the study begins.
The trials are expected to cost about NT$33.27 million (US$1.02 million), of which a portion will be subsidized by the Ministry of Economic Affairs, the company said in a filing with the Taiwan Stock Exchange.
TMB-607 is the only long-acting parenteral antiretroviral treatment for HIV, while all other available alternatives, such as Prezista, Reyataz and Kaletra, require one or two daily dosages administered orally, TaiMed said.
Although advancements in “AIDS cocktail” treatments have greatly improved survival rates among people with HIV, the disease has become a chronic illness requiring lifelong daily oral treatment.
EFFICACY
However, poor adherence to daily oral medications has become common among patients, leading to drug exposure insufficient to suppress HIV viral replication, which increases the likelihood for emergence and resistance, TaiMed said, adding that its long-acting injection would be more effective than competing products on higher regimen adherence among patients.
TaiMed on Tuesday also announced a favorable outcome for its phase III clinical trial for TMB-355, its HIV therapy in the class of viral-entry inhibitors, as 82.5 percent of 40 patients tested had exhibited a statistically significant reduction in virus load.
Yuanta Securities Investment Consulting Co (元大投顧) analyst Peggy Lee (李珮菁) said TMB-355 might be commercialized after receiving US FDA approval before the end of this year.
NEAR-TERM LOSSES
However, Yuanta is conservative on the drug’s near-term contribution to TaiMed based on the company’s licensing agreement with Canada-based Theratechnologies Inc, saying TaiMed might still post a net loss this year, before returning to the black next year.
“The actual contribution of the drug will depend on market reception and Theratechnologies’ marketing capability,” Lee said in a note on Wednesday.
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