Immuno Cure is a biotechnology group based in Hong Kong Science Park also committed to advancing healthcare solutions.
Poredeen grants ICB the exclusive rights to manage the importation and logistics for the HMTM# tablets under the NPP such that qualified prescribing doctors in the Territories can request HMTM# on behalf of eligible patients. HMTM# is currently undergoing clinical evaluation for its potential use in managing Mild Cognitive Impairment ("MCI"), Alzheimer's Disease ("AD") and behavioural-variant Fronto Temporal Dementia ("bvFTD"). It is not registered for commercial sale in the Territories. This NPP marks a significant milestone in the parties' joint mission to combat some of the world's most challenging and prevalent neurodegenerative diseases in the Territories.
Promising results are observed in LUCIDITY, TauRx's third and latest global Phase 3 clinical trial of HMTM#, offering hope to many patients and their families. LUCIDITY comprised a 12-month double-blind controlled Phase 3 clinical trial followed by a 12-month period in which all participants received HMTM# at 16 mg/day as a monotherapy. The trial investigated changes in various clinical and biomarker outcomes comparing HMTM# 16 mg/day with methylthioninium chloride ("MTC") given 4 mg twice weekly as a control over the first 12 months.
The safety profile seen in LUCIDITY remains positive and consistent with earlier published HMTM# trials data. There were no treatment-related serious adverse events or evidence of amyloid-related imaging abnormalities ("ARIA") in LUCIDITY. The LUCIDITY trial is now complete and TauRx is preparing peer-reviewed publications to report the full 24-month data.
Alzheimer's Disease is one of the leading causes of death throughout the world and one of the most important public health issues to be addressed globally. TauRx will contribute to addressing this unmet need with data from LUCIDITY. In the United Kingdom, TauRx is actively pursuing approval from the Medicines and Healthcare products Regulatory Agency ("MHRA UK") through the Innovative Licensing and Access Pathway ("ILAP"). TauRx was granted an Innovation Passport in May 2022, marking the first stage of the approval process, indicating MHRA UK's recognition of the potential importance of this medication for Alzheimer's Disease.
TauRx is also submitting the HMTM# results from LUCIDITY and earlier trials for regulatory approval in the USA. TauRx and Poredeen will be meeting and submitting data packages to other drug regulators in more territories, including the People's Republic of China ("China"), soon.
"This appointment reflects our unwavering dedication to improving the lives of those impacted by AD," stated TauRx's Managing Director, Dr SENG Shay Way, "We are delighted to appoint ICB as NPP Manager so that doctors may request this groundbreaking product for their eligible patients in need. Through this appointment, we aim to make a substantial and positive difference in the fight against AD thereby enhancing the quality of life for the patients, their families and caregivers."
"We focus on upholding the highest quality standards and compliance with regulatory guidelines," Poredeen's Executive Director, Dr LOH Yin Sze echoed, "where patient safety and well-being are of paramount importance, and our dedicated team will collaborate closely with ICB to provide ongoing support and education regarding this groundbreaking drug."
Securing this appointment not only expands Immuno Cure's position as a leading player in the biotech sector into pharmaceutical services but also showcases ICB's commitment to addressing critical unmet medical needs of AD patients through the launching of the NPP for prescribing doctors' immediate access to TauRx's HMTM#.
"We are delighted to be appointed the exclusive NPP Manager by Poredeen. Through our close relationship with healthcare institutions and practitioners, ICB will ensure the efficient and timely accessibility of HMTM# to the prescribing doctors and their patients," ICB's Chairman, Dr Percy Cheng said. "ICB will work closely with healthcare institutions, professionals, patient advocacy groups, and regulatory authorities to ensure the swift, safe and responsible availability of this groundbreaking treatment to eligible patients in need in Hong Kong and Macau."
TauRx, Poredeen and ICB are strategically aligned and committed to propel forward in their mission to transform the landscape of neurodegenerative disease treatment and make a profound improvement to the lives of those affected by MCI, AD and bvFTD and their families.
HMTM# is an investigational drug which has not received approval for any indications in the Territories, and its efficacy and safety have not yet been evaluated for registration purposes.
Disclaimer: This press release contains commercial information. It does not constitute any medical advice, and should not be treated as such. Any questions about any medical matter should be directed to medical practitioners or other professional healthcare provider.
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The issuer is solely responsible for the content of this announcement.
About TauRx and Poredeen:
The TauRx group of companies was established in 2002 in Singapore, continuing a collaboration with the University of Aberdeen, with primary research facilities and operations based in Aberdeen, UK. The company has dedicated the past two decades to developing treatments and diagnostics for Alzheimer's and other neurodegenerative diseases due to protein aggregation pathology.
TauRx is dedicated to research in neurodegenerative diseases and is a leader in AD research, with a mission to discover, develop and commercialise innovative products for the diagnosis, treatment and cure of neurodegenerative diseases caused by toxic protein aggregations.
Poredeen is a wholly-owned subsidiary of TauRx that holds exclusive rights for China, including Hong Kong SAR and Macau SAR.
For more details, please click here: https://www.taurx.com
About LUCIDITY:
LUCIDITY is the only late-stage clinical trial specifically targeting the tau pathology of Alzheimer's Disease.
Aggregation of abnormal tau protein is one of the hallmark pathologies. Tau aggregation and the subsequent formation of tau tangles disrupt neuronal function, a process that begins many years before symptoms of dementia are seen. Tau pathology correlates strongly with Alzheimer's severity and the clinical decline (loss of memory and ability to care for one's self) commonly seen in people with Alzheimer's.
The LUCIDITY trial is designed to confirm the efficacy and safety of HMTM* (Hydromethylthionine Mesylate) to support regulatory submission as the first disease modifying tau targeting treatment for Mild Cognitive Impairment and Mild-to-Moderate stages of Alzheimer's disease.
*Previously also abbreviated to LMTM and LMTX.
For more details, please click: https://taurx.com/the-science/clinical-trials
About Immuno Cure and ICB:
Immuno Cure is a clinical stage biotechnology group based in the Hong Kong Science Park, focusing on research and development of immunotherapies for cancers, inflammatory and infectious diseases based on its patented PD-1-enhanced DNA vaccine and Anti-Δ42PD1 Antibody platforms; with two DNA vaccine candidates currently in clinical trials. ICB is a member of the Immuno Cure Group, dedicated to providing professional services with innovative pharmaceutical therapies.
For more details, please click here: www.immunocure.hk
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