Biopharmaceutical company Invex Therapeutics (ASX: IXC) has identified several preferred formulation candidates and narrowed its search for a contract manufacturing organisation (CMO) that will manufacture its Presendin drug.
Invex is focused on commercialising Presendin for treatment of neurological conditions caused by raised intracranial pressure.
Today’s news comes despite COVID-19-related challenges and delays.
Invex evaluated a number of CMOs which specialise in the formulation of peptides for clinical and commercial purposes.
As part of the process, the company received several detailed proposals for the manufacture of Presendin for late-stage clinical trials and commercial supply.
The proposals met the stringent current Good Manufacturing Practicies regulatory requirements including those set out by the US Food and Drug Administration and the European Medicines Agency.
Invex has then undertaken additional analysis in relation to cost per unit at commercial volumes. The analysis includes potential pricing structures, and takes into account market access dynamics and overall patient acceptability.
“The proposals and contract discussions are well-advanced and in the process of further legal and commercial review,” Invex stated.
“Invex will update the market once the manufacturing selection process has been completed and a binding manufacturing agreement signed.”
At the end of the March quarter, Invex had $33.2 million cash in the bank, with average quarterly expenditure of less than $500,000 over the past 12 months.
Invex has repurposed the drug Exenatide which is currently used to treat type two diabetes.
As part of this, Invex has renamed it Presendin. In repurposing the drug, Invex is developing it to treat neurological conditions caused by raised intracranial pressure.
The company is currently focused on idiopathic intracranial hypertension, which it considers a large and growing market opportunity with no current regulatory approved treatments.
IIH occurs when accumulation of cerebral spinal fluid accumulates and increases the pressure inside the brain.
This results in debilitating symptoms for sufferers including daily headaches and vision problems.
Invex is currently planning a phase III trial evaluating Presendin in IIH.