Clinical-stage biopharmaceutical company Invex Therapeutics (ASX: IXC) has reported a busy quarter focused on the development and commercialisation of Presendin for neurological conditions relating to raised intracranial pressure (also known as idiopathic intracranial hypertension).
In June, the company received written responses from the US Food and Drug Administration’s Division of Neurology relating to a proposed phase III clinical trial of the drug.
The responses covered overall study design, and in particular, intracranial pressure and headache as key endpoints, which harmonised with the European Medicines Agency (EMA) requirement for demonstrating a “statistically significant and clinically meaningful effect” on intracranial pressure and a clinical outcome measure.
The FDA considered intracranial pressure as an appropriate secondary endpoint; however, recommended Invex consider a clinically meaningful effect on visual function, such as perimetric mean deviation (PMD) as a primary endpoint.
Invex has since commenced discussions with regulatory and scientific advisors to further understand the responses and clinical strategies which may allow for the design a phase III trial applicable to the US FDA and EMA.
During the quarter, Invex also continued to advance discussions with contract manufacturing organisations capable of producing Presendin for supply of the drug at clinical trial level and commercially at scale.
The company said it was confident of a commercial outcome to benefits both parties, given that patients are expected to require Presendin long-term to maintain normal levels of intracranial pressure and reduce the clinical symptoms of headache and vision impairment.
Invex’s suite of intellectual property assets expanded in April, with a trademark for Presendin formally registered by the US Patent and Trademark Office in April.
Additional registrations were granted by the European Union Intellectual Property Office and IP Australia.
Strong financial position
Invex closed the quarter in a strong financial position with cash and cash equivalents of $32.7 million, and overall cash outflows from operating expenditure of $0.45 million.
Cash outflows included $0.17 million in research and development costs associated with the preparation and filing of a study protocol and statistical analysis plan to the US FDA and regulatory advice associated with the written response.
The company also incurred costs associated with direct research and development staff costs of $0.10 million.
Administration and corporate outlay of $0.20 million related to compliance costs associated with being an ASX-listed company, including stock exchange and directors fees, and audit and legal costs.
Aggregate amounts paid to related parties of Invex and their associates included in the above costs were $0.17 million for the quarter.