Clinical-stage biopharmaceutical company Invex Therapeutics (ASX: IXC) has rounded out a September quarter focused on the continued development and commercialisation of lead candidate Presendin for the treatment of neurological conditions related to raised intracranial pressure.
In its latest quarterly report, the company said it had invested time and resources into preparation of an Evolve phase III clinical trial of the drug and progressed patient recruitment during the period.
It received approval from the US Food and Drug Administration (FDA) for an investigational new drug (IND) application and for the start of the trial in the US for patients with idiopathic intracranial hypertension (IIH).
Engagement from US doctors to participate in the trial was reported to be strong and Invex said it planned to open up to 10 clinical sites in the region.
Collaboration agreement
The achievement of the IND has been considered a major milestone and follows a collaboration agreement signed last year with South Korean pharmaceutical company Peptron to ensure Invex’s drug meets stringent FDA requirements.
Clinical supplies of Presendin and placebo drug product have been manufactured by Peptron and delivered to Invex’s depots in Australian and the UK for transfer to active new clinical sites ahead of first patient dosing.
A second shipment of initial drug and placebo supplies arrived in the US during the quarter for packaging and labelling for US trial sites.
Ethics approval
During the period, Invex secured approval from Australia’s Human Research Ethics Committee to include three public hospitals in Melbourne and Sydney in the Evolve phase III trial.
These sites are expected to start recruiting patients before year end.
Invex also received ethics approvals from authorities in the UK and Australia.
It said further clearances from New Zealand, Israel and Europe were expected in the new year.
Financial position
Invex closed the September quarter in a strong financial position with cash and cash equivalents of $27.3 million, compared to $29.3 million for the previous corresponding period.
Overall cash outflows totalled $2 million, compared to $1 million in the previous period.
Outflows included $1.1 million for research and development, and $310,000 for administration and corporate costs.
Invex said cash outflows would increase in subsequent periods as it starts recruitment for the phase III trial in the second half of the financial year.
Aggregate amounts paid to related parties of the company and associates during the quarter totalled $240,000.
