A world-first antipsychotic injectable drug developed in Perth will accelerate its path to market after the company behind it, Reliis, was acquired by a Melbourne biotechnology developer.
A world-first antipsychotic injectable drug developed in Perth will accelerate its path to market after the company behind it, Reliis, was acquired by a Melbourne biotechnology developer.
ASX-listed Melbourne biotech Patrys told the market this morning it had entered into a binding agreement to acquire 100 per cent of Perth-based Reliis Pty Ltd, with hopes of advancing its quetiapine injectable for delirium in ICU and aged care.
The drug, RLS-2201, is a proprietary injectable formulation of quetiapine; an antipsychotic drug already used in tablet form to treat schizophrenia and bipolar disorder.
In the statement, Patrys said it acquired Reliis due to the well-established need among frontline ICU, aged-care and palliative-care specialists for acute-care treatments for delirium.
"Targeting a US$2 billion global market, with delirium affecting over 500 million people annually and no approved acute-care treatments representing a major unmet medical need," the statement said.
Oral formulations of drugs like and including quetiapine are used off-label in approximately 40 per cent of ICU delirium cases, but the unpredictable absorption, delayed onset and limited control over dosing cause delays and safety challenges.
A key benefit quetiapine already being in use is that Reliis can, and has flagged intention to, pursue FDA 505(b)(2) and EMA abridged approval, a common path for reformulated therapeutics.
FDA 505(b)(2) is a new drug application for a modified version of an already approved drug that relies partly on existing public data to speed up approval, reducing the need for duplication of costly clinical trials.
An EMA abridged approval would mean some pharmacological tests, toxicological tests and clinical trials would not need to be provided, with the abridged application only allowed to be lodged with the authority which evaluated and authorised the original product; and therefor holds the dossier on the product.
Some 110 million shares were issued to Reliis shareholders, equating to $3,520,000 at the company's current share price of 3.2 cents per share.
Two tranches of performance rights which will convert to shares on a one-for-one basis were also issued.
Class A would see 40,000,000 performance rights convert to shares upon the first patient being dosed in a phase one clinical study; while Class B would mean 30,000,000 performance rights convert to shares upon successful Investigational New Drug approval.
Patrys will also settle some $300,000 in Reliis debts via the issuing of 25 million shares to Reliis lenders; provide some 50 million shares to advisors and facilitators of Reliis and another 6.66 million shares for advisors of Patrys.
Reliis nominated co-founders Leanne Kite and Dino Cercarelli to join the Patrys board as non-executive directors, as was Reliis' right under the terms.
Ms Kite has spent over 20 years in finance, governance and investor relations across biotech, mining and energy. She currently leads investor relations at an ASX200 mining company, and previously spent over a decade with Woodside Energy.
She was a Business News 40under40 Award winner, while Reliis won the Great for the State platinum award at the 2023 Innovator of the Year Awards.
Mr Cercarelli is currently the chief operating officer of ACTA, the national peak body for clinical trials and clinical quality registries.
He previously spent close to a decade leading research and clinical trial operations at St John of God Health Care.
