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- IXC has received IND approval from the FDA for Presendin™ and for commencing Phase III clinical trial of IIH EVOLVE.
- The development allows Invex to ship Presendin™ to the US clinical investigators taking part in the trial.
- The company expects to recruit first patient into the trial during 2H 2022.
Shares of Invex Therapeutics Ltd (ASX:IXC) rallied by over 18% to AU$0.665 in the early hours of trading on 19 August 2022.
The surge in IXC share price followed an important update about approval from the United States Food and Drug Administration (FDA) for the company’s Investigational New Drug Application (IND) for Presendin™.
IXC also received approval for starting the IIH EVOLVE Phase III clinical trial in the US for patients with Idiopathic Intracranial Hypertension (IIH).
The company has highlighted an annual addressable market of AU$1.6 billion for IIH in the EU, the UK, and the US.
The approval of the IND allows Invex to ship Presendin™ to the US clinical investigators taking part in the IIH EVOLVE clinical trial.
IIH EVOLVE is designed to meet the requirements for market approval of Presendin™ for IIH treatment in the EU, UK, and Australia.
The clinical-stage biopharmaceutical firm is advancing with the opening of several clinical sites across the US to assist the IIH EVOLVE trial. It will now complete the required institutional contracts and human ethics committee approvals to enable patient recruitment on time.
What the management has to say?
Professor Alex Sinclair, Executive Director and Chief Scientific Officer of Invex, said that they are anticipating a positive efficacy outcome of the study will help further discussions with the FDA on the future registration requirements of Presendin™ for IIH patients in the US.
Invex chairman Dr Jason Loveridge expects the trial outcomes to potentially change the lives of IIH patients. The disease doesn't have any approved drug, and it has progressed in many patients where invasive surgeries are the only way for treatment, Loveridge said.
Annual report highlights strong financial footing
As per its annual report for the period ended 30 June 2022, Invex Therapeutics held cash of AU$29.3 million.
Other key highlights of the period included
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