台微體規劃赴美籌資21億元 2019-01-06 23:02經濟日報 記者黃文奇/台北報導 台灣微脂體去年在美國那斯達克（NASDAQ）完成第二上市，今年將利用此次參加JP摩根生醫年會（J.P. Morgan Healthcare Conference）的契機，引進國際關鍵投資人，預期今年中若旗下的利基新藥TLC599、TLC590臨床試驗順利，將在美進行上看7,000萬美元（約新台幣21億元）的籌資計畫。葉志鴻表示，該公司手上的現金部位仍足夠未來幾年的營運，但新藥開發時程長，而公司新藥產品正進入關鍵開發階段，籌資除了為了充實營運資金外，也希望能藉此引進好的合作夥伴，一起做大市場。台微體旗下現有兩項開發中的關鍵利基新藥產品，包括抗關節炎疼痛產品TLC599、術後長效止痛藥物TLC590。葉志鴻表示，599目前 完成臨床二期試驗，六個月的持續力，優於主要競爭對手Flexion的Zilretta的double Zilretta 12周的效期，599今年將挺進三期，下半年開始收案，而590方面，今年首季將公布臨床一/二期試驗數據。葉志鴻表示，該公司現正針對599的臨床三期試驗，與美國食品藥物管理局（FDA）討論試驗規劃，目前看來進度順利，最快7月可以開始收案，另外，旗下產品生產規劃已經完成，製造上也沒什麼問題，未來取得上市許可後，產品可順利進行商業化的生產。針對599與美國FDA討論臨床三期試驗規劃，葉志鴻表示，第一、FDA官員願意就此藥物與開發公司進行討論，表示當局對該產品的重視，其次、新藥開發若未與FDA討論，就逕送臨床方案，即使FDA未否決該案而做三期，最後可能因未盡符合FDA要求，而須補做其他試驗，更費時間與成本。日前，TLC599在二期試驗上，達成主要評估目標及關健次要評估目標，該產品在12、16、20、及24周的評估指標達成統計上顯著意義，且受試患者用藥後耐受性良好，沒有與治療相關的嚴重不良事件，更完成了多項關健次要評估目標。葉志鴻表示，目前市面上缺乏一個能長效抑制關節炎疼痛的治療方案，TLC599二期臨床試驗結果證實其具備著改變未來市場遊戲規則的潛力，而599試驗主持人David Hunter博士也表示，TLC599一直到為期六個月的評估期結束時還仍然有療效，是他見過的長效緩釋關節注射型藥物裡最長久的。
Zilretta is an extended-release injectable suspension of triamcinolone acetonide, a short-acting corticosteroid. ZIlretta is specifically indicated for the management of osteoarthritis pain of the knee.
About ZILRETTA On October 6, 2017, ZILRETTA was approved by the U.S. FDA as the first and only extended-release intra-articular therapy for patients confronting osteoarthritis-related knee pain. ZILRETTA employs proprietary microsphere technology combining triamcinolone acetonide — a commonly administered, short-acting corticosteroid — with a poly lactic-co-glycolic acid (PLGA) matrix to provide extended pain relief over 12 weeks. The FDA approval of Zilretta was based on a multi-center, international, randomized, double-blind, parallel-arm, placebo- and active-controlled study in subjects with osteoarthritis pain of the knee. A total of 484 patients were treated and followed for up to 24 weeks. A total of 470 patients (97%) completed follow-up to Week 12, the time point for primary efficacy determination, and 443 (91.5%) completed to Week 24. The primary efficacy endpoint comparing Zilretta to placebo was change from baseline at Week 12 in the weekly mean of the Average Daily Pain intensity scores (ADP) as assessed by a 0-10 Numeric Rating Scale (NRS). Zilretta demonstrated a statistically significant reduction in pain intensity at the primary endpoint versus placebo. Zilretta also demonstrated a reduction in pain intensity scores each week from Weeks 1 through 12.
About Osteoarthritis (OA) of the Knee OA, also known as degenerative joint disease, affects more than 30 million Americans and accounts for more than $185 billion in annual expenditures. In 2016, more than 15 million Americans were diagnosed with OA of the knee and the average age of physician-diagnosed knee OA has fallen by 16 years, from 72 in the 1990s to 56 in the 2010s. The prevalence of OA is expected to continue to increase as a result of aging, obesity and sports injuries. Each year, more than 15 million Americans are treated for OA-related knee pain, and approximately five million OA patients receive either an immediate-release corticosteroid or hyaluronic acid intra-articular injection to manage their knee pain.
About Flexion Therapeutics Flexion Therapeutics (Nasdaq:FLXN) is a biopharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis, a type of degenerative arthritis. The company's core values are focus, ingenuity, tenacity, transparency and fun. For the past two years, Flexion has been named one of the Best Places to Work by the Boston Business Journal, and Flexion was also recognized as a Top Place to Work in Massachusetts by The Boston Globe in 2017. Flexion Therapeutics, Inc., lead product candidate includes Zilretta, an intra-articular injection for the management of osteoarthritis (OA) pain of the knee. The company also develops FX101 and FX201, which is a pre-clinical stage programs for the treatment OA of large joints. The company was founded in 2007 and is headquartered in Burlington, Massachusetts.
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