‘Aussie virus killer not be sneezed at’ - WE AUST today (extract)
As the nation hyperventilates over a delay in the vaccine rollout, Starpharma is rolling out a new line of defence against the coronavirus in global markets.
Viraleze is a nasal spray containing a virucide that forms a barrier which can irreversibly block the COVID virus. The active ingredient SPL7013 was discovered over a decade ago by ASX-listed Starpharma, led by Jackie Fairley. It “inactivates the virus, which is the most effect you can get,” Fairley says. “It binds to those same spike proteins the vaccines are aimed at and all of it happens externally to the body. You have ... blocked its ability to infect you and it will as a result be unable to function.”
It was February last year when Fairley and her team began brainstorming how their antiviral could help. “It was originally identified because of its very potent activity against a number of viruses including HIV, herpes and HPV, so we continued to test it against other viruses, like the adenovirus which causes conjunctivitis . When COVID emerged, it seemed like a natural thing to explore.” The Starpharma team found that the same broad-spectrum virucide inactivates more than 99.9 per cent of COVID viruses within a minute.
In the 12 months since Starpharma’s lean team in Melbourne have repurposed the broad spectrum antiviral, registered it in Britain and Europe where COVID is rife, and set up manufacturing.
Ten days ago, Viraleze was launched in Britain through LloydsPharmacy, retailing at ›15 ($27). “It is selling very well online ,” says Fairley. LloydsPharmacy’s famous Wigmore Street chemist in London, John Bell & Croyden, is the first of the brick and mortar outlets, with more to follow later this month.
Viraleze is recommended for use every four to six hours and a maximum four times a day. Its main aim is to defend against high viral loads, where for example social distancing is not possible. Consumer research for Starpharma by BCG found people would use it before going to the supermarket , or on public transport or a plane.
The Starpharma team contemplated various versions of the product, including intravenous, but in the end it landed on the nose. “The nose is the most important route of infection for COVID. Most of the receptors the virus binds to and enters your body are in your nasal mucosa,” Fairley says.
It is data that has allowed Starpharma to bring Viraleze to market fast. The same active ingredient is already in two of the company’s on-market products: VivaGel and LifeStyles condoms. “It’s actually in the antiviral condom that we have licensed to Ansell for its activity against HIV,” Fairley says. “We then through serendipitous observation in women in a clinical trial observed that it worked in bacterial vaginosis and then we undertook that whole development program for the BV gel.”
Fairley says that clinical trials on VivaGel over several years helped with regulatory approval. “The extensive use and the fact that the product has been on market for more than five years now — all of that adds to the data base that you have on the active ingredient. It is all supportive data in terms of safety and tolerability.
“It is the same molecule which is in the other products on another mucosal surface. It’s a very large molecule so it is not absorbed into the body and acts entirely external to the body. “It sits there on your nasal mucosa and if you inhale the virus it basically engulfs and inactivates the virus so it can’t bind to the cells of your nasal mucosa and it can’t enter your body.”
There are no known side-effects to this virucide but it is hard to measure its efficacy in the real world. Clinical trials on efficacy are not required by Europe or Britain. In regulatory terms, it is arguable that Viraleze is closer to a hand sanitiser than a vaccine. “The claims that our product makes are not prevention of disease, which is what a vaccine says,” Fairley said. “We are not claiming that it prevents COVID, we are claiming that it kills virus, whether it is COVID or influenza or SARS or MERS, and all of that data you can generate in a laboratory .”
Identifying the active ingredient was a step forward for Starpharma, but there were many other hurdles to jump. Testing facilities that could work fast were needed. Jackie Fairley found some ex-Biota staff that had regrouped as 360biolabs near Melbourne’s Alfred Hospital. Testing began in mid-April last year through the lockdown and later at the Scripps Institute in San Diego as the active ingredient was reformulated into a nasal spray.
Starpharma successfully applied for $1m in funding from the Medical Research Future Fund that was specifically aimed at products that could have an impact by August 2021. Then there were the spray device components and manufacturing to think about.
As luck would have it, the company’s manufacturer of Viva-Gel in Belgium also manufactured nasal sprays. “That was a real advantage because we have been able to get them to immediately help us in sourcing the sprays and bottles. They have been fantastic,” Fairley says. “We had raw material on hand because of the VivaGel product. “We immediately started stockpiling more raw material. At that stage, no one really knew if we were going to have vaccines. Everyone was looking for whatever protective measures one could employ in masks and distancing .”
StarPharma has filed a new patent related to the activity of its SPL7013 on the COVID virus which is now being made under contract with specific raw material manufacturers. “It would be quite difficult for another party to learn how to make that without assistance from us because we’ve invested a lot in IP into the scale-up of the material. The chemists who were the inventors of the compound and synthesised it for the very first time are still employees of Starpharma,” the CEO adds with some pride.
In September, to fund the commercialisation of Viraleze, Starpharma raised $45m from institutions. This year the share price has roared up over 30 per cent.
At this stage, the company has not provided guidance on the product. “It is obviously a relatively difficult market to estimate but certainly the uptake so far in the UK has been very positive and the reaction has been very positive . So it does have the potential to be material.”
Viraleze is planned for the Australian market, with Starpharma looking to submit the product in due course. But for now, the next priority is Europe where danger from COVID is so clear and present.
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