Clinical stage biopharmaceutical company Invex Therapeutics (ASX: IXC) has reported strong progress made over the September quarter in the development and commercialisation of its drug Presendin for neurological conditions relating to raised intracranial pressure.
Presendin is the trademarked name Invex has given to the existing drug Exenatide, which has already been approved for the treatment of type two diabetes. Invex is repurposing it for indications including idiopathic intracranical hypertension (IIH), acute stroke and traumatic brain injury.
Last month, the company achieved a manufacturing milestone by signing an exclusive collaboration with Korea-based biopharmaceutical company Peptron.
The deal involves Peptron providing Invex with access to its intellectual property including extensive preclinical and clinical data relating to its proprietary sustained-release formulation of Exenatide, which will be labelled Presendin for Invex’s clinical trials in IIH as well as for commercial use if regulatory approved.
The exclusive agreement applies globally and provides a defined price per dose for the supply of Presendin for clinical studies and for the first 10 years following the first sale.
Invex has also granted Peptron an exclusive licence for IIH in Korea.
During the quarter, Invex convened scientific advisory meetings with key opinion leaders, which sought to examine the plausibility of designing a single United States/European Union clinical trial for the registration of Presendin that would meet the requirements of both the US Food and Drug administration (FDA) and European Medicines Agency (EMA) for market approval.
The review included an independent, comprehensive clinical review of IIH patient data as it related to perimetric mean deviation (PMD) and a review of published clinical evidence in scientific literature.
The results of the review and strategic decision by the Invex board, including the preferred clinical and regulatory plans are expected early in the fourth quarter of this calendar year.
European patent secured
In August, Invex received a European patent for the treatment of elevated intracranial pressure, which covers the use of GLP-1 receptor agonists including Presendin (Exenatide) in reducing elevated pressure associated with IIH.
The patent will provide intellectual property protection until at least August 2035.
It follows the company’s issued patents in the US and Japan, thus providing broad IP protection as Invex progresses its clinical development plans for Presendin.
Exenatide has also been granted orphan drug designations in the US and Europe, providing seven and 10 years of market exclusivity, respectively in these markets.
Strong financial position
Invex closed the September quarter in a strong financial position with cash and cash equivalents of $32 million. Overall cash outflows for the period were $740,000.
Cash outflows included research and development expenditure related to the company’s planned phase three clinical trial, regulatory and expert advice on FDA feedback, IP and admin costs.
Invex said cash outflows are expected to increase in subsequent quarters as the company begins to place orders for Presendin from Peptron for clinical trial purposes.
Its phase three trial is due to begin in the first half of 2022.