-- EMA has endorsed iX Biopharma's proposed Phase 3 clinical development
programme for Wafermine(TM)
-- EMA Scientific Advice provides clarity on registration pathway in Europe
SINGAPORE, Dec. 8, 2020 /PRNewswire/ -- Specialty pharmaceutical company iX Biopharma Ltd (SGX:42C) ("iX Biopharma" or, "the Company") is pleased to announce that it has received positive feedback from the European Medicines Agency (EMA) in its scientific advice to the Company regarding its Phase 3 clinical development programme for Wafermine(TM), its sublingual ketamine wafer, for registration in Europe (the "EMA Scientific Advice").
In the EMA Scientific Advice, the EMA endorsed the Company's proposed design of the pivotal Phase 3 studies. The Phase 3 programme, which has been similarly agreed by the US FDA, consists of two randomised, double blind, placebo controlled studies, one in an orthopaedic pain model (bunionectomy) and one in a soft-tissue pain model (abdominoplasty). The primary efficacy measure for both studies will be SPID12, which is the summed pain intensity difference over 12 hours. The summed pain intensity difference over 24 hours (SPID24) and 48 hours (SPID48) will be evaluated as secondary endpoints. The Phase 3 studies will use the same pain models and primary endpoint that was successfully evaluated in Wafermine(TM)'s Phase 2b clinical study.
With the successful outcome of the EMA Scientific Advice and End-of-Phase 2 meeting with the US FDA, the Company has now reached consensus with the regulators of the major markets of Europe and the United States on the remaining clinical development required to support the approval of Wafermine(TM) for the treatment of acute moderate to severe pain in those markets.
Dr. Janakan Krishnarajah, Chief Operating Officer and Chief Medical Officer of iX Biopharma said: "EMA's endorsement of the proposed Phase 3 programme design is an exciting achievement that affirms the robustness of our clinical development approach. The EMA response confirms that our development strategy will satisfy the clinical study requirements for both US and European approval, and provides clarity to programme cost and timelines. This makes Wafermine(TM) a very attractive late stage partnering opportunity for both US and European markets."
For more information on Wafermine(TM), please refer to the link below:
About iX Biopharma Ltd
iX Biopharma is a specialty pharmaceutical and nutraceutical company listed on the Catalist board of the Singapore Exchange Securities Trading Limited (SGX-ST), operating a fully integrated business model from drug development to manufacturing and supply, with facilities in Australia. The Group is focused on the development and commercialisation of therapies for diseases of the central nervous system using novel, patent-protected formulations for sublingual delivery.
Contact for media:
Dr Janakan Krishnarajah
Chief Operating Officer and Chief Medical Officer
T: +65 6235 2270
E: firstname.lastname@example.org [mailto:email@example.com]
Director, Corporate and Commercial Strategy
T: +65 6235 3212
E: firstname.lastname@example.org [mailto:email@example.com]
Kamal Samuel/Ngo Yit Sung/Jonathan Wee
T: +65 6438 2990
E: Tech@financialpr.com.sg [mailto:Tech@financialpr.com.sg]
Web site: https://www.ixbiopharma.com/