The first person formally treated with Recce Pharmaceutical’s (ASX:RCE) next-generation antibiotic calls it a “bloody miracle” after it cured a chronic, debilitating sinus infection he had suffered from for decades.

Fletcher, a 59-year-old Perth resident who works in the financial industry, was able to access Recce’s R327 compound last year under Australia’s Special Access Scheme, a pathway for unapproved medicine used to treat potentially deadly conditions.

In a phone interview late last week, Fletcher told Stockhead he had been plagued by recurring sinusitis for about three decades, leaving him feeling “dead and exhausted”.

At first standard antibiotic treatments had been able to treat it, but eventually, the pseudomonas aeruginosa bacterium developed a lipid outer layer that made it resistant to the usual drugs.

Fletcher had to take ciprofloxacin, or “cipro,” a powerful antibiotic with unpleasant side effects.

“It also killed everything in my stomach, and I used to hate taking it,” Fletcher said.

And while the cipro would clear a flare-up, the infections always returned in about six months.

Fletcher even had antibiotics intravenously administered through a PICC line (peripherally inserted central catheter) to his heart, and endured seven different operations to clear his sinuses, most recently in 2013. But nothing completely worked.

“It was a pretty vicious cycle,” he said.

When his infection flared up again last year, he approached Recce about using its R327 synthetic antibiotic that the company had been testing in animals.

Quite the process

Giving Fletcher access to the unapproved drug was “quite a rigorous process”, said Recce chief executive James Graham.

But eventually, an independent medical committee decided that the antibiotic could be given to Fletcher, since it has been approved for use on burn victims as part of a phase 1/2 clinical trial at the Fiona Stanley burns unit in Perth.

Graham said as far as he knew there had been no burns victims treated with the Recce 327 yet, which would make Fletcher the first human formally treated with the antibiotic. It was possible scientists tested it on themselves informally, he added.

Fletcher said he used the topical spray three times a day up his nasal passages.

“It was an interesting sensation, bracing,” he said. Within 90 minutes his sinuses began to feel clearer and less inflamed, and he noticed less discharge.

Within a few days he no longer felt the stinging sensation when he used the spray. Nor was he sweating and having trouble sleeping, and his nose was no longer running.

Blood samples found no detectable sign of the pseudomonas aeruginosa infection — although a few weeks later, an opportunistic “common bacterium” took up residence where the drug-resistant bacteria had been previously.

A course of septrim forte tablets cleared that up, and the initial bacteria remains undetected.

“We were a little surprised, in a positive sense, because were know how resistant that bacteria was — we knew what we were up against,” said Graham. “We knew we were up for a hell of a fight here.”

Next-generation antibiotics

Recce’s antibiotics were developed by company founder Dr Graham Melrose, the former head of research at Johnson & Johnson Asia Pacific and Australia.

Graham said Dr Melrose was tinkering in his retirement, realised he wasn’t he wasn’t that great at carpentry and decided to pick up his test tubes again to work on a pressing public health problem.

Bacteria are increasingly evolving resistance to standard antibiotics, making them far deadlier.

The World Health Organization estimated in 2019 that 700,000 people die each year due to drug-resistant diseases and says that number could jump to 10 million by 2050, causing as much economic damage as the Global Financial Crisis.

Graham says Dr Melrose was able to develop a synthetic compound that contrasts with all existing antibiotics, which are naturally derived. (Penicillin, for example, is synthesised from Penicillium moulds).

According to the company, R-327’s potency doesn’t diminish even with repeated use, meaning that bacteria can’t develop resistance and evolve into “superbugs”.

In addition to the burns victim trial, Recce is moving to test intravenous administration of Recce 327 to treat sepsis, which is caused when bacteria enter the bloodstream. A phase 1 clinical trial is set to soon begin in Adelaide.

‘It’d be amazing’

Recce disclosed Fletcher’s story in a company announcement last week but didn’t seek to publicise it further, cognisant he wasn’t treated as part of a clinical trial and the results “must be considered anecdotal”.

But after some hesitation, a company publicist agreed to see if “Patient X” wanted to speak publicly, and he did.

“For a sinus patient, it’s a bloody miracle,” he told Stockhead. “Sinus infections are just invidious.

“I’m not sure if it’s going to solve everybody’s sinus infections, but if it can solve some of them, it’d be amazing. ”

Fletcher said finally get of the infection has given him his life back and he’s even gotten engaged since his cure.

Graham, who received a bottle of fine wine from Fletcher as thanks, said the experience of being able to assist him was profoundly moving.

“It’s greatly uplifting,” he said. “I don’t necessarily make it my life’s work to help people, but being able to do so like this has been very positive, in a sense I never anticipated.”