MIRA Pharmaceuticals Announced A Key Development Milestone For Its Novel Topical Formulation Of Ketamir-2 Demonstrated Successful, Dose-proportional Drug Release In A Validated Laboratory Study-8K

MIRA製藥公司宣佈其新型局部製劑Ketamir-2在經過驗證的實驗室研究中表現出成功的劑量依賴性藥物釋放，達成了一個重要的開發里程碑-8K

Benzinga · 04/23 19:42

The results of the in vitro release testing (IVRT) confirm that Ketamir-2 can be delivered reliably and consistently through a topical cream—a challenge that many water-soluble compounds fail to overcome when formulated in hydrophobic bases. This breakthrough provides MIRA with a new opportunity to pursue localized, non-opioid pain treatment options that may complement its oral Ketamir-2 formulation currently in Phase 1 trials.
MIRA is now initiating preclinical efficacy studies to assess whether the topical formulation can offer therapeutic effects in models of inflammatory and neuropathic pain. These studies are expected to provide data to guide potential clinical advancement.
MIRA is also evaluating whether the topical Ketamir-2 program may meet the criteria for Fast Track designation under the United States Food and Drug Administration ("FDA")'s expedited development program for serious conditions. If granted, Fast Track status could facilitate closer communication with the FDA and potentially accelerate the path to first-in-human studies.
MIRA's oral Ketamir-2 formulation is currently being evaluated in a Phase 1 clinical trial, with a Phase 2a trial in diabetic neuropathy expected to commence later this year.

體外釋放測試（IVRT）的結果證實，Ketamir-2可以通過局部乳膏可靠且持續地遞送——這是許多水溶性化合物在疏水性基質中配方時難以克服的挑戰。這個突破爲MIRA提供了一個新的機會，以追求可能補充其正在進行一期臨牀試驗的口服Ketamir-2配方的局部非阿片類疼痛治療選項。
MIRA現在正在啓動臨牀前療效研究，以評估局部配方是否能在炎症和神經性疼痛模型中提供治療效果。這些研究預計將提供數據，以指導潛在的臨牀進展。
MIRA還在評估局部Ketamir-2計劃是否符合美國食品和藥物管理局（"FDA"）快速通道指定的標準，該計劃針對嚴重疾病的加速開發。如果獲得，快速通道狀態可以促進與FDA的更密切溝通，並可能加速首個人體研究的進程。
MIRA的口服Ketamir-2配方目前正在一期臨牀試驗中評估，預計二期a期在糖尿病神經病症中的試驗將在今年晚些時候開始。

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