| TLC (4152.TWO), a clinical-stage specialty pharmaceutical company dedicated to the development and commercialization of best-in-class novel nanomedicines that combine its proprietary lipid-assembled drug delivery platform with approved active pharmaceutical ingredients (API), today announced that it has completed enrollment of the last patient in its Phase II clinical trial of TLC599 for the treatment of osteoarthritis (OA) pain. The accrual and treatment phases of this clinical trial are complete; all enrolled patients are being followed-up as per study protocol. Topline results are expected in the second half of 2018.
The randomized, double-blind, placebo-controlled Phase II clinical trial evaluates the safety and efficacy of two different dose levels of TLC599 (12mg and 18mg) compared to placebo in 72 patients with knee OA pain. The primary endpoint is the change from baseline in the WOMAC-pain subscale at week 12. Other analyses, such as change from baseline in WOMAC-pain subscale at weeks 16, 20 and 24, are included in the secondary endpoints in order to more accurately determine efficacy duration.
“We are excited to have reached full enrollment of patients for this trial,” comment George Yeh, President of TLC. “We believe that the completion of this enrollment puts us on-track to report topline data in the second half of 2018. Results of this trial will provide valuable information in our design of future pivotal clinical trials.”
TLC599 is TLC’s proprietary BioSeizer™ formulation of dexamethasone intended for the treatment of OA pain, designed to deliver both rapid onset pain relief, similar to currently marketed immediate release steroids, plus sustained pain relief for more than three months. TLC599’s API, dexamethasone, confers higher potency than triamcinolone acetonide, the API used in an FDA-approved product. In preclinical studies, TLC599 showed no proteoglycan loss, indicating that TLC599 could potentially confer less chondrotoxicity than other currently marketed products and may enable safer repeat dosing.
https://www.tlcbio.com/en-global/press-releases/detail/News_20171226 |
