Invex Therapeutics plans to start Phase III clinical trials of its neurological drugs in the first half of 2022.Clinical-stage biopharmaceutical company Invex Therapeutics (ASX: IXC) reported that the development and commercialization of its drug Presentin, a drug for the treatment of neurological diseases associated with elevated intracranial pressure, made strong progress in the September quarter.
Presendin is the brand name given by Invex for the existing drug Exenatide, which has been approved for the treatment of type 2 diabetes. Invex re-used it for indications, including idiopathic intracranial hypertension (IIH), acute stroke and traumatic brain injury.
Last month, the company signed an exclusive cooperation agreement with South Korean biopharmaceutical company Peptron , achieving a milestone in production.
The transaction involves Peptron providing Invex its intellectual property rights, including a large amount of preclinical and clinical data related to its patented extended-release formulation Exenatide. Exenatide will be labeled as Presentin for use in Invex's IIH clinical trials, and if approved by regulatory authorities, it can also be used for commercial purposes.
This exclusive agreement applies globally and provides a fixed price per dose of Presentin for clinical research and the first 10 years after the first sale.
In addition, Invex has granted Peptron an exclusive license for IIH in Korea.
Clinical examination
This quarter, Invex convened a scientific consultation meeting with key opinion leaders. The study was designed to test the feasibility of designing a single US/EU clinical trial for Presentin registration that will satisfy the US Food and Drug Administration (FDA) And the market approval requirements of the European Medicines Agency (EMA).
The review includes an independent, comprehensive clinical review of IIH patient data because it is related to Perimeter Mean Deviation (PMD) and summarizes the published clinical evidence in the scientific literature.
The results of the review and strategic decision of Invex’s board of directors, including preferred clinical and regulatory plans, are expected to be announced early in the fourth quarter of this year.
European patent protection
In August of this year, Invex received a European patent for the treatment of elevated intracranial pressure, including the use of GLP-1 receptor agonists, including Presentin (Exenatide), to reduce IIH-related intracranial pressure elevation.
The intellectual property protection of this patent will last at least until August 2035.
It follows the company's patents issued in the United States and Japan, thereby providing extensive intellectual property protection as Invex advances its clinical development plan for Presentin.
Exenatide has also obtained orphan drug authorization in the United States and Europe, providing market exclusivity for 7 years and 10 years, respectively.
Strong financial position
Invex was financially sound at the end of the September quarter, with cash and cash equivalents of A$32 million. The total cash outflow during the period was AUD 740000.
Cash outflows include R&D expenditures related to the company's planned third phase clinical trials, regulatory and expert advice from the FDA, intellectual property rights, and management costs.
Invex said that as the company begins to order Presentin for clinical trials from Peptron, it expects cash outflows to increase in the next few quarters.
The third phase of the trial will begin in the first half of 2022.
