Taipei, Taiwan June. 19th, 2023

Allgenesis Biotherapeutics Inc., a clinical-stage specialty pharmaceutical company focused on developing novel ophthalmic drugs, today announced topline data from the company’s Phase 1b clinical trial for AG-80308, a first-in-class, formyl peptide receptor (FPR) agonist formulated as an aqueous solution eye drop for the treatment of Dry Eye Disease (DED). The Phase 1b trial is a multi-center, double-masked study to evaluate the safety, tolerability, and dose-response of AG-80308 Formulation A 0.001%, 0.03%, or 0.1% and Formulation B 0.03% dosed twice daily for 3 months in 84 dry eye patients.

AG-80308 was considered safe at all doses tested BID for 3 months. AG-80308 provided improvements in both signs and symptoms:

• Signs: improvements in corneal staining, conjunctival staining, and tear production responders
• Symptoms: improvements in the 7-item visual analog scale, including dry eye discomfort, eye dryness, burning/stinging, itching, foreign body sensation, photophobia, and pain.
• AG-80308 Formulation A 0.001% and Formulation B 0.03% provided the best overall safety, tolerability, and efficacy profile.

“We are very encouraged with our data showing that patients are seeing improvements in multiple signs and symptoms from the Phase 1b trial as early as 2 weeks”, said Dr. Madhu Cherukury, CEO of Allgenesis. “AG-80308 can offer dry eye patients an effective treatment that can be used long-term without the AEs associated with other therapies” added Dr. Cherukury.

 “With the positive results from the Phase 1b trial, we are looking forward to moving this program into Phase 2, where we will evaluate 2 doses of AG-80308 in formulation B against vehicle.  This will be an ideal drug for treating chronic dry eye patients due to its unique MOA and excellent potency” said Dr. Sunil Patel, Chief Medical Officer Allgenesis.

Allgenesis has begun preparations to support initiation of the Phase 2 trial in 1Q2024.

For additional inquiries regarding collaboration and partnering opportunities related to AG-80308, please contact Jack Chang (jack.chang@allgenesis.com) or Sandy Lai (sandy.lai@allgenesis.com) for more information.

About Allgenesis Biotherapeutics Inc.

Allgenesis is a clinical-stage biopharmaceutical company headquartered in Taipei, Taiwan. The company is focused on research and development of novel medicines for the treatment of eye diseases. Current projects in the pipeline include AG-73305, a potential blockbuster drug for the treatment of DME, nAMD, and other retinal diseases such as RVO and AG-80308 for Dry Eye Disease.

About AG-80308

AG-80308 is a novel, first-in-class, formyl peptide receptor (FPR) agonist formulated as an aqueous solution eye drop for the treatment of inflammation associated with Dry Eye Disease (DED). The project was in-licensed from Allergan (now AbbVie) in May 2020.

新源生技﹕臨床1b數據顯示AG-80308能治療多種乾眼症的徵兆和症狀

新源生技(Allgenesis Biotherapeutics Inc.)，專注於開發眼科藥物的臨床階段新藥公司，公佈該公司用於治療乾眼症(Dry Eye Disease) 的 AG-80308 臨床1b試驗數據。AG-80308是目前唯一市場首見(first-in-class)甲醯肽受體(formyl peptide receptor, FPR)促進劑，劑型為水溶液眼藥水。AG-80308 臨床1b試驗是一項多中心、雙盲研究計畫，旨在評估84名乾眼症患者於使用AG-80308劑型A 0.001%、0.03%或0.1%，以及劑型B 0.03%後之安全性、耐受性和劑量反應，治療方式為每天兩次並持續用藥3個月。

本次試驗結果顯示，AG-80308所有測試劑量均為安全，對於乾眼症的客觀徵兆(signs)和主觀症狀(symptoms)療效顯著，結果簡述如下：

• 客觀徵兆(signs)：角膜染色、結膜染色、淚液分泌反應均有改善。
• 主觀症狀(symptoms)：經由視覺類比量表(visual analogue scale, VAS)評估，以下7項症狀皆有明顯改善，包括乾眼症不適、眼乾、燒灼/刺痛、發癢感、異物感、畏光、疼痛。
• 在所有測試劑量中，劑型A 0.001%和劑型B 0.03%整體的安全性、耐受性和療效最佳。

新源生技執行長Madhu Cherukury博士表示：「此次臨床數據顯示，患者最快在用藥2周後就能改善多項乾眼症徵兆和症狀，這讓我們備受激勵。AG-80308可為患者提供一種有效、且可長期使用的安全治療方法，同時較無其他乾眼症藥物所引起的不良反應。」

新源生技醫療長Sunil Patel博士則表示：「鑒於臨床1b試驗的正向結果，新源生技將積極地推動AG-80308進入臨床2期，屆時將比較安慰劑及2個劑量的AG-80308劑型B之安全性及有效性。由於獨特的作用機制和出色的療效，這將是長期治療乾眼症最理想的藥物。」

新源生技已積極規劃在2024年第1季度啟動臨床2期試驗。

如需諮詢與AG-80308有關的授權與合作機會，請聯絡Jack Chang(jack.chang@allgenesis.com)或Sandy Lai(sandy.lai@allgenesis.com)。

關於新源生物科技股份有限公司

新源生技是一家總部位於台灣的臨床階段生技新藥公司，專精於研究和開發眼科新藥。新源生技目前正在推進的專案包含創新大分子藥物AG-73305，可用於治療DME、nAMD、RVO等視網膜疾病，以及新穎性小分子AG-80308，用於治療乾眼症。

關於AG-80308

AG-80308是一種新穎的、市場首見(first-in-class)甲醯肽受體(FPR)促進劑，配製成水溶液眼藥水形式，用於治療乾眼症相關炎症。該藥物於2020年5月獲得愛力根(Allergan) (現為AbbVie的授權)。