- Invex Therapeutics (IXC) receives orphan drug designation (ODD) from the European Medicines Agency (EMA) for Exenatide to treat moderate to severe Traumatic Brain Injury (TBI)
- This marks the second ODD for Exenatide in Europe after receiving the green light in 2017 to use the drug to treat Idiopathic Intracranial Hypertension (IIH)
- The company is currently investigating its lead drug, Prsendin, a once-per-week, sub-cutaneous, sustained-release (SR) Exenatide microsphere formulation, to assess whether the formula can reduce intracranial pressure in conditions associated with elevated ICP
- ICX Executive Director Dr Thomas Duthy says the ODD is an “important initial step” in protecting the commercial opportunity in moderate to severe TBI
- ICX shares are up 55.8 per cent and trading at 60 cents at 3:49 pm AEST
Invex Therapeutics (IXC) has been granted orphan drug designation (ODD) from the European Medicines Agency (EMA) for Exenatide to treat moderate to severe Traumatic Brain Injury (TBI).
This marks the second ODD for Exenatide in Europe after receiving the green light in 2017 to use the drug to treat Idiopathic Intracranial Hypertension (IIH).
The company is currently investigating its lead drug, Presendin, a once-per-week, sub-cutaneous, sustained-release (SR) Exenatide microsphere formulation, to assess whether the formula can reduce intracranial pressure in conditions associated with elevated ICP, which includes moderate and severe TBI.
“Since we first discovered the potent ICP lowering effects of Exenatide in pre-clinical models and within our completed phase two Pressure IIH trial, the company has explored other elevated intracranial pressure disorders, including TBI,” Invex Executive Director Dr Thomas Duthy said.
“Securing a European ODD for Exenatide is an important initial step in protecting the commercial opportunity in moderate to severe TBI, which is forecast to represent an annual market opportunity of US$2.45 billion by 2027, growing 9 per cent per annum.”
ICX reports that currently, there are no EMA or FDA-approved therapies that specifically target IIH.
The EMA provides incentives for medicines granted with ODD within the European Union (EU). These include a ten-year market exclusivity, clinical trial assistance, access to the centralised authorisation procedure in Europe, and fee reductions.
IXC shares were up 55.8 per cent and trading at 60 cents at 3:49 pm AEST.