Ann: Invion - successful completion of P2 study of INV102, page-24

Media coverage.  In today's Herald Sun:

A New Australian drug shown to double smokers’ chances of quitting in trials is being touted as a possible treatment for asthma, cystic fibrosis and other lethal respiratory conditions.

By directly targeting the damage being done to a smoker’s lungs rather than their nicotine addiction, the experimental Inv102 drug is hoped to offer a whole new approach to quitting.

That process also opens the door to saving lives from airway conditions such as asthma by blocking the build up of mucus that can impact on breathing in the same way it creates “smokers cough”.

Releasing results from its latest US trials on Monday, Australian developer Invion revealed one-in-five chronic smokers were able to completely quit cigarettes after using Inv102 for two months, compared to one-in-10 participants who quit while using a placebo.

Invion chief executive officer Dr Greg Collier said he hoped to use the results to push for a final trial and approval from the US Food and Drug Administration as a smoking cessation medication, which would fast-track Inv102’s “bigger picture” approval for other diseases.


“We are right in that sweet spot in terms of approval for smoking cessation,” Dr Collier said.

“The beauty of this is drug is that it does not have the neurological effects — it is a totally different mechanism and goes straight to the lungs whereas both the (existing nonsmoking) drugs have quite problematic effects on the brain.”

Existing prescription medications Champix and Zyban have been shown to double a smoker’s chance of quitting by dulling their reliance on nicotine, but have side effects including nausea and have been linked to a spate of suicides.

While it is still to enter Phase Three trials, the early data shows similar quit rates for Inv102.

But it works by blocking a signalling process called the beta arrestin pathway that tells the cells lining a person’s lungs to transform and begin producing mucus when they are impacted by smoke or disease — preventing lungs becoming clogged with mucus, causes them to cough or have difficulty breathing.

It does this by does this by binding a molecule onto the beta receptors on surface of the lung so they cannot send out the signal to transform into mucus-producing cells.

As the blocked cells die they are replaced by regular epithelial cells, rather than mucus-producing cells, effectively breaking the cycle and giving a smoker a window in which it is easier to quit.

While the anti-smoking version of the drug is a pill, Dr Collier said an inhaled version that directly coats the lungs of people with asthma, cystic fibrosis and other severe respiratory conditions was being developed.

“The defect that is common to all these diseases — COPD from heavy smoking, or sever asthma from allergy, or cystic fibrosis — they all have this mucus change in the lungs,” he said.

“You don’t die of constriction, it is the mucus that fills up the lungs and there isn’t a drug that directly effects that mucus products, all the drugs at the moment effect dilation or the inflammation.

“In animal studies we know it works at about 100th of the concentration when inhaled, so if we can get it directly to the lung it will have even better effects for asthma.”

The Australian company is now trying to attract investment from larger biotech interests as it awaits a meeting with the powerful FDA to set up the process for a final Phase 3 trial.