Invex Therapeutics in strong position to launch Presendin trials

Invex Therapeutics (ASX: IXC) has confirmed its strong financial position as it gets set to commence recruitment for phase three clinical trials of lead drug Presendin on patients with newly diagnosed idiopathic intracranial hypertension (IIH).

In its June quarterly report released today, the clinical-stage biopharmaceutical company declared it is fully funded to complete the trial for Presendin registration purposes in the European Union, United Kingdom and Australia from current cash reserves. At the end of the quarter, cash and cash equivalents totalled $29.3 million.

Invex recorded cash outflows for the June quarter of $1 million and said this is expected to increase in subsequent periods as recruitment for the trial commences. Although as the company is undertaking active research and development (R&D) in Australia with the trial, Australian government R&D tax incentives are expected to be recognised in future financial years.

Getting ready for the global IIH EVOLVE phase three trial

Invex made considerable progress during the June quarter towards the launch of its global IIH EVOLVE phase three clinical trial. In June, it secured its first regulatory approval for the trial with the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK.

Subsequent to the end of the quarter, the company also received approval by the Human Research Ethics Committee (HREC) and clinical trial notification scheme clearance by the Therapeutics Goods Administration (TGA) in Australia.

In addition, clinical supplies of Presendin and the placebo drug product manufactured by Peptron under a collaboration and manufacturing deal are currently awaiting customs clearance for labelling in the United States before dispatch to initial clinical sites.

New chief operating officer

From the start of July, Invex head of operations Carol Parish assumed the key executive role of chief executive officer at the company.

Ms Parish has more than 33 years of experience within the pharmaceutical/biotechnology industry and has been accountable for all phases of drug development in multiple therapy areas.

Prior to joining Invex, she was the global clinical operations lead at Intercept Pharmaceuticals (NASDAQ: ICPT) and held various senior clinical positions at GlaxoSmithKline-owned Stiefel Laboratories, Merck & Co (NYSE: MRK) and Johnson & Johnson (NYSE: JNJ).

Scientific meeting presentations raise interest in EVOLVE trial

During the quarter, Invex hosted many presentations at specialist medical conferences relating to the key findings of its phase two PRESSURE trial in IIH.

According to the company, the peer review process for this trial by way of the numerous presentations has resulted in a “strong level of scientific and medical interest” in the IIH EVOLVE phase three trial and has “greatly facilitated” discussions relating to participation in the trial.