SGX-listed iX Biopharma has launched a programme to develop a sublingual dexmedetomidine wafer for the treatment of agitation in dementia and other indications.
The programme is part of the company’s strategy to repurpose existing approved drugs using its proprietary WaferiX drug delivery platform technology to target new therapeutic areas with unmet or significant medical needs.
According to iX Biopharma, there were over 5.8 million people in the US with Alzheimer’s disease, which is the most common type of dementia, in 2020. The same number of people experience over 100 million agitation episodes per year.
Patients who experience agitation may exhibit excessive uncontrollable aggression and physical, verbal or motor violence. These behavioural issues often lead to greater distress than memory changes.
There are currently no FDA-approved therapies for the treatment of dementia-related agitation. Current approaches to address agitation are suboptimal, adds the company.
Further to the company’s statement, the global acute agitation and aggression treatment market size was US$4.10 billion ($5.72 billion) in 2020 and is projected to expand to US$7.09 billion by 2031 with a CAGR of 5.1% from 2021 to 2031.
iX Biopharma says it has completed formulation work on the sublingual dexmedetomidine wafer. A Phase 1 human pharmacokinetic study comparing its sublingual wafer to the marketed IV dexmedetomidine product will now commence with results expected in December or in January 2023.
Upon the successful completion of the study, the company plans to file an investigational new drug (IND) application with the US food and drug administration (FDA) for a Phase 2 study in patients with agitation.
“The sublingual dexmedetomidine programme is an important milestone in the continued progress of iX Biopharma. It demonstrates the versatility of our proprietary WaferiX drug delivery platform technology and our commitment to research and development of innovative therapies,” says Eddy Lee, iX Biopharma’s chairman & CEO.
“We are focusing on dementia-related agitation as it is an unmet medical need which has massive healthcare and economic impact. Globally, dementia costs over US$1 trillion per year and represents one of the leading causes of disability for elderly adults. Until a cure is found, agitation in dementia will keep growing with rising geriatric populations,” he adds. “Our sublingual dexmedetomidine has the potential to ameliorate the impact of the disease and ease the tremendous emotional toll and mental burden on caregivers.”
As at 10.05am, shares in iX Biopharma are trading flat at 16.3 cents.