15th November 2021
Oneness Biotech (4743.TT), a leading biotech company listed on the Taipei stock exchange, and Tanner Pharma UK Limited (“Tanner Pharma”), a specialist pharmaceutical services provider of medicine access solutions, announced the initiation of an early access program for Fespixon in Europe, the UK, Russia, Latin America, the Middle East and North Africa (MENA) where Fespixon is not commercially available.
Fespixon (developed under research code: ON101) is the world's first drug to treat diabetic foot ulcers (DFUs) by regulating the macrophages with superiority in incidence of complete wound closure to the standard care (60.7% vs 35.1%, p=0.0001) according to its publication on the JAMA Network Open. It has been approved by the Taiwan FDA, is under NDA review by China NMPA, and is under multiple NDA submissions to Asian health authorities. A Fast Track designation was granted to Fespixon earlier this year in the US where there is an ongoing Phase 3 study NCT04962139. For US patients who do not qualify for the clinical trial but who may be eligible for expanded access, requests for treatment with Fespixon will be considered on a case-by-case basis via the Oneness expanded access policy.
A diabetic foot ulcer is an open sore or wound on the foot, which can be a life-threatening disease in severe cases and may lead to amputation or even death among diabetic patients. In the past 20 years, there has been limited progress in the drug development process for diabetic foot ulcers, greatly impacting patients around the world. With the unique mechanism to regulate macrophages in chronic wounds caused by hyperglycemia, Fespixon has shown promise as an active-healing option for diabetic foot ulcers. The early access program with Tanner Pharma will enable more DFU patients in the world who would have otherwise gone without treatment to have access to Fespixon.
Healthcare professionals can obtain details about the Fespixon Access Program by contacting Tanner Pharma at:
Telephone: +44 (0) 2039 408111
Fespixon is a topical macrophage-regulation new drug to treat diabetic foot ulcers. It is currently marketed in Taiwan and under clinical development or regulatory submissions to the global major markets. In the international phase 3 randomized, controlled study, Fespixon has been demonstrated with clinical superiority to the standard of care in the overall DFU patients and those with DFU-related risk factors. The phase 3 clinical data and its novel mechanism of action have been published on the JAMA Network Open https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2783718.
About Oneness Biotech
Oneness Biotech has been established since 2008 and is the only listed biotech company in Taiwan that has been included in the MSCI standard index. Oneness is dedicated to the development of first-in-class new drugs for chronic dermatology and immunology under different clinical stages. In addition to Fespixon, Oneness has an anti-IgE B cell antibody under phase 2a development in global partnership with LEO Pharma A/S. The rest of the pipeline consists of the biologic new drug for asthma indications and a COV-flu siRNA new drug targeting a broad range of SARS-CoV-2 infections including the Delta variant. For more information, visit www.onenessbio.com/en.
About Tanner Pharma Group
Tanner Pharma Group is a specialist pharmaceutical services provider based in Charlotte, USA with offices in Europe and Latin America. Tanner provides a portfolio of service offerings focused on improving the global access to medicines. Through its TannerMAP division, Tanner supports manufacturers with ethical, controlled, and compliant access to their innovative medicines in countries where they are not commercially accessible. For more information, visit www.tannerpharma.com.