Written on the 26 March 2015 by Antony Scholefield


THE US Food and Drug Administration (FDA) has approved a clinical strategy for inhaled nadolol from Brisbane-based biotech company Invion.

Nadolol is already available as a beta-blocker, but Invion CEO Dr Greg Collier explains that the company is developing the drug for other uses.

"Nadolol is a drug we're repositioning for respiratory diseases," he says.

"In our program, we have two trials underway one for asthma and one for smoking cessation.

"The FDA approval gave us the green light, and we can move onto toxicology studies."

Attention has focussed on nadolol's potential to ease "smoker's cough", which afflicts people attempting to give up cigarettes.

The FDA accepted Invion's proposed toxicology program for nadolol, and agreed on the outline, objectives, and targets for Invion's next phase of studies.

It also accepted Invion's chemistry and manufacturing plan, which is ongoing at 3M Drug Delivery Systems.

Collier says Invion has a "fee-for-service relationship with 3M" and could continue the partnership all the way into eventual commercial production.

Invion is also expecting further results for its zafirlukast trials to arrive in the first quarter of 2015.

Zafirlukast is used for the maintainance-treatment of asthma. Collier says Invion has "been working for the last 12 months" on "repositioning this as an inhaled therapy."

"The side-effect profile will be significantly reduced," he says.

Chief medical officer Dr Mitchell Glass is leading the development of zafirlukast, having worked on programs involving the drug prior to his appointment at Invion.

Further results for a third drug, ala-Cpn10, are expected in June 2015.

The drug, also referred to as INV103, dampens the autoimmune response in patients with lupus. Enrolments for new clinical trials will be finalised in the next few days.

Invion has already recorded positive interim data from its phase two trials of the drug.

In November, Invion signed a Share Purchase and Convertible Security Agreement with The Australian Special Opportunity Fund, an institutional investor managed by The Lind Partners.

Among other benefits, the deal will allow Invion to access convertible security between $500,000 and $1 million during the next five months.

The company also received two research and development cash rebates in the second half of 2014, one of $800,000 and another of $400,000.

Author: Antony Scholefield





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