• Recce Pharmaceuticals (RCE) has received the results of an animal study showing the "positive" efficacy of its new anti-infective formulation, RECCE 111, against bacterial sinusitis in mice
• The bacterium is a leading cause of bacterial pneumonia and meningitis in the U.S. and a common cause of bloodstream infections, including sepsis, ear and sinus infections
• The study assessed the dose-dependency and in-vivo antibacterial activity of Recce's lead candidates, R327 and R111, against bacterial sinusitis in a mouse model of acute bacterial rhinosinusitis infection
• Twelve groups of 10 mice were assessed in the research
• Both compounds showed significant antibacterial capability with no detected abnormalities 
• The drugs are expected to undergo further sinusitis studies in due course
• Recce shares are up 0.52 per cent, trading at 97 cents each

Recce Pharmaceuticals (RCE) has received the results of an animal study showing the "positive" efficacy of its new anti-infective formulation, RECCE 111, against bacterial sinusitis in mice. 

Recce is pioneering the development and commercialisation of new classes of synthetic anti-infectives, designed to address urgent global health problems around antibiotic resistant superbugs and emerging pathogens.

Bacterial sinusitis is a leading cause of bacterial pneumonia and meningitis in the U.S. and a common cause of bloodstream infections, including sepsis, ear and sinus infections. 

The study, conducted by an independent contract research organisation, assessed the dose-dependency of Recce's patented lead candidate R327 and R111 in-vivo antibacterial activity against bacterial sinusitis in a mouse model of acute bacterial rhinosinusitis infection.

Twelve groups of 10 mice were assessed to determine the effectiveness of the drugs against the bacterium.

Three groups were treated with varying intranasal doses of R327 twice daily and showed a significant dose-dependent antibacterial effect when compared to early infection and vehicle control.

Meanwhile, three groups were treated with varied doses of R327 intravenously, also showing a significant dose-dependent antibacterial effect when compared to early infection control and vehicle control.

Further, three of the twelve groups were treated with different intravenous doses of R111 and displayed significant dose-dependent antibacterial effect when compared to early infection control and vehicle control.

The positive control, Azithromycin, was given twice daily and had a bactericidal effect when compared to vehicle control at five days post infection.

The tested compounds both showed significant antibacterial capability with no detected abnormalities. Both are expected to undergo further sinusitis studies.

Recce Pharmaceuticals CEO James Graham commented on the research.

"We're continually excited by the potential of Recce's anti-infective compounds and are encouraged by these positive indications," James said.

"Moreover, this further enhances the breadth of Reece's synthetic polymer platform," he added. 

Recce's background clinical activities with R327 continue to progress.

Recce Pharmaceuticals shares are up 0.52 per cent, trading at 97 cents at 12:22 pm AEDT.

Read the full article on The Market Herald here.

• Recce Pharmaceuticals' (RCE) R327 anti-infective drug has found success being used by a patient with a multidrug-resistant sinusitis infection
• The man's doctor applied to use R327 via the Australian drug watchdog's Special Access Scheme-A and has since reported positive results
• Specifically, the patient reported applying the drug improved their sinuses and testing show it removed any detectable signs of their infection
• It's a pleasing result for the health stock, however, the company warns as only one person used the drug the results must be considered anecdotal

Recce Pharmaceuticals' (RCE) R327 synthetic anti-infective drug has found success being used by a patient with a multidrug-resistant sinusitis infection.

Patient use

The 59-year-old male has suffered infections throughout his adult life and currently has a multidrug-resistant Gram-negative P. aeruginosa sinusitis infection in their upper nasal eustachian tube.

His current infection has been unresponsive to previous surgeries and antibiotic treatments, prompting the patient's doctor to apply to seek out Recce's 327 anti-infective treatment.

In order to access samples of R327, the doctor applied under the Therapeutic Goods Association's Special Access Scheme-A, in which a patient must be considered "seriously ill, where death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment."

Pleasing reaction

Once the patient was given the green light to use the drug by the TGA, he began applying 5 to 10 drops per 20 millilitres of R327 in saline solution, three times a day into his infected nasal passages.

Pleasingly, the man reported that his sinuses began to feel clearer, less inflamed and less full of discharge within 90 minutes of application, and post-dosing blood tests have showed no detectable signs of the P. aeruginosa infection.

"We are thrilled by this positive indication for this patient with a terribly, debilitating condition that has been driven over many years by this recalcitrant pathogen," CEO James Graham said.

However, despite the encouraging success, Recce did warn that the results were considered anecdotal, as it involved only one patient.

The company also stated it is continuing to clinically trial the drug and its other anti-infectives for safety and efficacy.

Following today's positive update, shares in Recce Pharmaceuticals have jumped up 7.14 per cent to trade at $1.05 per share at 1:06pm AEST.

Read the full article on The Market Herald here. 

• Recce Pharmaceuticals (RCE) has secured a patent from the European regulator covering two of its synthetic anti-infective formulations
• This is the second time Recce has been granted a patent in the Patent Family 3 group after a patent was previously granted by Japan's regulator
• The new patent will cover marketing and manufacturing activities associated with the company's Recce 327 and Recce 529 drug candidates until February 2037
• These drugs aim to stop the rapid spread of bacteria and viruses, respectively
• The new E.U. patent also covers Recces's use of the candidates on viruses like COVID-19, HIV and Ross River Virus

Recce Pharmaceuticals (RCE) has secured a patent from the European regulator covering two of its synthetic anti-infective formulations.

The new patent will cover marketing and manufacturing activities associated with the company's Recce 327 and Recce 529 drug candidates until February 2037.

These drugs aim to stop the rapid spread of bacteria and viruses, respectively, and both are at different stages of development.

Additionally, the new E.U. patent allows for the use of these drugs on viruses like COVID-19, HIV and Ross River Virus.

It also protects how R327 or R529 is administered, be it orally, via injection, inhalation or transdermal dose application.

This is the second time the healthcare stock has been granted a patent from the Patent Family 3 group. Japan's regulator has also granted Recce a similar patent from this patent family, with further international applications pending.

Commenting on the patent, Recce Chief Executive Officer James Graham said the E.U. was a key market for the company's drugs.

"Recce’s intellectual property portfolio continues to grow in-line with our business strategy and the unprecedented global infectious disease crisis before us," he said.

"Our market-monopolies reinforce our unique opportunity among a significant-range of both bacterial and viral pathogens," James concluded.

Read the full article on The Market Herald here.

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• Reccce Pharmaceuticals (RCE) has become a dual-lister after assuming its position on a major German exchange
• The Australian pharmaceutical player will commence trading on the prominent European exchange today under the code R9Q

• RCE hopes the move will broaden its institutional and retail investors base across the E.U. and fuel awareness of its products 
• The dual listing was enacted without any affiliated capital raising activities, which Recce says allows wider investor reach with minimal cost 
• Recce Pharmaceuticals is up a healthy 3.06 per cent trading at $1.01

Reccce Pharamceuticals (RCE) has become a dual-lister after assuming its position on a major German exchange.

The Australian-based company will begin trading on the exchange today under the code R9Q with no affiliated capital raising activities. 

According to Recce, the move is expected to broaden its institutional and retail investor base across the E.U., in alignment with increasing activity in the region.

The dual listing grants Recce a position on the twelfth largest stock exchange in the world by market capitalisation. 

Recce has appointed Deutsche Gesellschaft Für Wertpapieranalyse as its investor and corporate relations advisor in Europe to engage investors and fuel awareness of Recce's products.

According to the company, the dual listing was enacted without many of the typical primary listing procedures, which it describes as a widening of investor reach with minimal cost. 

Chairman of Recce Pharmaceuticals John Prendergast spoke highly of the dual listing. 

"Dual listing on the Frankfurt Stock Exchange is a wonderful new chapter in our global strategy, " he commented. 

"It sees the connection of E.U. biotech and overseas capital with the company’s New Classes of Synthetic Anti-Infectives development program.”

Read the full article on The Market Herald here.

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1. Recce Pharmaceuticals (RCE) has locked in agreements to assess its new spray-on antibiotic for topical burn wound treatment in a series of clinical trials
2. The 30-patient trials are set to take place at Fiona Stanley hospital in Perth with the first candidates prepared to be tested in the current quarter
3. More specifically, the study will assess the safety and efficacy of RECCE 327 against a broad range of infectious disease on chronic burn wounds

In an agreement with Fiona Stanely hospital's burns unit in Perth, the study will assess RECCE 327's safety and efficacy against a broad range of infectious disease on chronic burn wounds in up to 30 patients.

The first patients are set to be tested in the current quarter and the trial will take place over 14 days, with the first 10 receiving RECCE 327 daily and the remaining 20 to receive treatment three times per week. 

The study is being overseen by three infectious disease and burns experts, namely Dr Edward Raby, Dr Chris Heath and Professor Fiona Wood. 

Dr Raby said antibiotic resistant is a major issue after burns injuries. 

"Our team is keen to identify and add new treatments with the potential to overcome antibiotic resistance and improve patient's lives," he explained. 

The spray-on formulation has been specifically developed for the study and was produced at the company’s manufacturing facility to the same human clinical study standards as the previously announced in the phase one intravenous clinical trial. 

Recce anticipates the two studies will run concurrently.

RECCE 327 was awarded Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act by the U.S. Food and Drug Administration, granting it fast track designation and 10 years of market exclusivity post-approval.

"We believe RECCE 327 has potential to make a significant impact in treating infections," Recce Pharmaceuticals Chairman Dr John Prendergast said.

"We look forward to working with the world-leading team at Fiona Stanley Hospital in advancing new treatment options for burns victims at increased risk of infection from multidrug-resistant organisms," he concluded.

Read the full article on The Market Herald here.

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• Recce Pharmaceuticals (RCE) has reported more strong anti-COVID-19 results from a screening study of its RECCE-327 synthetic anti-infective
• The drug is being tested against SARS-CoV-2, the virus that causes COVID-19, in an anti-viral screening program conducted by CSIRO and the Doherty Institute
• The latest round of results has proven RECCE-327 to be 99.9 per cent effective against SARS-CoV-2 at higher doses
• While Recce management said the company is "delighted" by the results, it will need to conduct further testing before deciding to pursue R327 as an anti-COVID treatment
• Either way, investors seem impressed with today's results, with Recce shares up almost 9 per cent this morning to trade at $1.12 per share

The drug is being tested against SARS-CoV-2, the virus that causes COVID-19, as part of an anti-viral screening program being conducted by the Commonwealth Scientific and Industrial Research Organisation and the Doherty Institute.

RECCE-327, or R327, already produced positive results in the early stages of the screening program, when Recce tested the ability of the product to inhibit the virus by half. 

Now, in the latest round of lab tests, R327 was proven to be 99.9 per cent effective against the SARS-CoV-2 virus at higher doses. Importantly, the treatment caused minimal toxicity in Vero cells, which are a typical lineage of cells used in cell cultures. 

R327 results

At a dose of 4000 parts per million, RECCE-327 showed a reduction in SARS-CoV-2 viral genome numbers to the point where the virus was no longer detectable in viral titration. 

In fact, reverse transcription-polymerase chain reaction (RT-PCR), which is a highly sensitive technique for viral detection, detected a three-log drop in viral genome copies. This essentially means there was a 99.9 per cent reduction in the virus. 

RT-PCR is the main method used to detect COVID-19 through swab testing in humans and animals. 

"We continue to be encouraged by the results from the antiviral SARS-CoV-2 screening program as it reinforces our belief in the potential of R327 against COVID-19 including emerging variant strains," Recce Non-Executive Chairman, Dr John Prendergast, said. 

However, while Recce management said the company is "delighted" by the results, it added that further testing still needs to be done before R327 is confirmed as being active against the virus that causes COVID-19. 

The company plans to take on further testing at higher dose levels to establish the IC50 and cytotoxicity of the treatment. IC50 refers to what concentration of the treatment is needed to inhibit the virus by 50 per cent. 

These next results will then help the company decide if it wants to pursue R327 as an anti-SARS-CoV-2 candidate.

Read the full article on The Market Herald here.

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• Recce Pharmaceutical's (RCE) anti-infective drugs have demonstrated positive test results in combatting SARS-CoV-2 or, the COVID-19 virus 
• The live animal studies concluded both RCE's R327 and R529 medications reduced viral load present in the blood of infected hamsters compared to a placebo group
• 40 hamsters were tested, each receiving higher or lower treatment doses of the drugs, respectively, or a placebo saline wash 
• While the study offers a good indication of the potential for nasal administration of Recce’s anti-infective compounds, further testing on larger animals must be completed before it can be deemed fully safe and effective 
• RCE shares are up modestly by 1.85 per cent, trading at $1.10

Live animal studies were completed on 40 Syrian golden hamsters to test the effectiveness of RCE's R327 and R529 medications against the virus. 

The hamsters were all infected with SARS-CoV-2 at the beginning of the trial and individually treated with either a higher or lower dose of the medication or a placebo saline wash. 

Findings concluded both RCE's R327 and R529 medications reduced the viral load, or the measure of total virus particles, present in the blood of infected hamsters compared to the placebo group.

While the study offers a good indication of the potential for nasal administration of Recce’s anti-infective compounds, further testing on larger animals must be completed before it can be deemed fully safe and effective.

A company spokesperson says a concurrent COVID-19 study on ferrets is underway and seeking to explore further methods of adminstering the medication and higher dose concentrations.

Data from these studies are expected in early 2021.

RCE shares are up modestly by 1.85 per cent at 9:14 am AEDT, trading at $1.10.

Read the full article on The Market Herald here.

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• Recce Pharmaceuticals (RCE) has now been granted a Japanese patent for its synthetic anti-infectives Recce 327 (R327) and Recce 529 (R529)

• The formulations aim to treat lipid-coated viruses — examples of which include coronaviruses, influenza, HIV, hepatitis, and Ross River virus
• The company's flagship drug, R327, is currently being tested against COVID-19 and has successfully moved to the next stage
• Japan is the second-largest pharmaceutical company in the world
• On the market this afternoon, Recce is up 5.07 per cent and is trading for $1.14 per share

The formulations aim to treat lipid-coated viruses — examples of which include coronaviruses, influenza, HIV, hepatitis, and Ross River virus.

Recce's flagship candidate, R327, is currently being tested against SARS-CoV-2, the virus that causes COVID-19. R529 is a new formulation of the anti-viral. 

The Japanese patent, dubbed 'Anti-virus Agent and Method for Treatment of Viral Infection', was granted by the Japan Patent Office (JPO) in the world's second-largest pharmaceutical market.

More broadly, there's an increasing demand for medical aid against infections caused by lipid enveloped or coated viruses in Japan, positioning Recce's candidates to meet the growing need. 

"Recce’s intellectual property portfolio continues to grow in-line with our business strategy and the unprecedented global infectious disease crisis before us," CEO James Graham said.

"At now 31 granted patents across three wholly-owned patent families, our market-monopolies reinforce our unique opportunity among a significant-range of both bacterial and viral pathogens," he added. 

Earlier this month, Recce reported positive anti-COVID results from a trial of its R327 product. The company found the drug showed "encouraging inhibition" against the virus and will now continue to the next stage of testing. 

On the market this afternoon, Recce is up 5.07 per cent and is trading for $1.14 per share at 2:37 pm AEDT.

Read the full article on The Market Herald here. 

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• Recce Pharmaceuticals (RCE) broke out of a trading halt and soared today after revealing positive anti-COVID results from its RECCE-327 (R327) product

• The drug is being tested against SARS-CoV-2, which is the virus that causes COVID-19, as part of a CSIRO and Doherty Institute screening program
• Recce says the drug showed "encouraging inhibition" of the virus and, as such, will now be progressing to the next stage of testing
• This stage will include some confirmatory in-vitro testing and a cytotoxicity assessment for R327
• While Recce stresses that the testing is only preliminary, Chairman Dr John Prendergast still says the company is highly encouraged by the results
• Investors seem encouraged, too, with Recce shares tacking on a neat 14.21 per cent this afternoon to close worth $1.08 each

Recce Pharmaceuticals (RCE) broke out of a trading halt and soared today after revealing positive anti-COVID results from its RECCE-327 (R327) product.

The synthetic anti-infective is being tested against SARS-CoV-2, the virus that causes COVID-19, in a lab as part of a Commonwealth Scientific and Industrial Research Organisation (CSIRO)/Doherty Institue antiviral screening program. 

Recce told shareholders the drug showed "encouraging inhibition" of the virus and, as such, will now be progressing to the next stage of testing.

The RECCE-327 test

Recce's drug candidate was tested against a positive control, which in this case was an investigational compound known as beta-d-N4 hydroxycytidine, or NHC. This control has been proven to be a highly-active compound against SARS-CoV-2 in vitro, but its so far not approved for human use. 

In the test, R327's half-maximal inhibitory concentration, or IC50, was investigated in different doses of the drug. Essentially, IC50 indicates how much of a drug is needed to inhibit the virus by half, giving the investigators an idea of the potency of the drug. 

While Recce's product showed signs of potential toxicity in the two highest concentrations tested, the overall test results were positive enough that the drug is now progressing to Stage 1b testing, where it will go through some confirmatory in-vitro testing and a cytotoxicity assessment. This stage of testing is slated to begin within weeks. 

Recce stressed that today's results are preliminary and more testing needs to be done before R327 is confirmed as being active against SARS-CoV-2. 

Nevertheless, Recce Chairman Dr John Prendergast said the company is highly encouraged by the results. 

"We are interested in seeing the next stage and look forward to continuing research on the effectiveness of R327 with the team at the Doherty Institute," John said. 

Meanwhile, Recce is busy testing some of its compounds in the U.S. against SARS-CoV-2 in ferrets. While no material results have come from the tests just yet, the company said the studies are progressing well, with results on track for release before the end of the year. 

Shares in Recce surged ahead following this afternoon's news, with the company gaining 14.21 per cent to close with shares worth $1.08 each. Recce has a $188.39 million market cap.

Read the full article on The Market Herald here. 

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• Recce Parmaceuticals (RCE) has been granted ethics approval to start a phase one/two study on patients with infected burn wounds
• The trial will test a spray-on formulation of candidate drug, RECCE 327, which is a broad-spectrum synthetic polymer antibiotic
• Recce anticipates the study will be sponsored by WA's South Metropolitan Health Service, with Fiona Stanley Hospital nominated as the study site
• A previously announced intravenous study will run in parallel to demonstrate the broad administration capabilities of RECCE 327
• Recce 327 is being developed for the treatment of blood infections and sepsis derived from E. coli and S. aureus bacteria – including their superbug forms
• Recce Pharmaceuticals is trading 4.72 per cent higher for $1.11

Recce Parmaceuticals (RCE) has been granted ethics approval to start a phase one/two study on patients with infected burn wounds.

The trial will test the company's drug candidate, RECCE 327, which is a broad-spectrum synthetic polymer antibiotic. 

The trial

The study will assess the safety and efficacy of RECCE 327 against a broad range of infectious bacteria on chronic burn wounds in up to 30 patients over two weeks.

10 patients will receive the drug daily, while a further 20 will receive treatment three times per week.

Recce anticipates the study will be sponsored by WA's South Metropolitan Health Service, with Fiona Stanley Hospital nominated as the study site.

Investigators will review the study data for clinical efficacy and toxicity before deciding to expand the trial to phase two to test the compound against the current best standards of care.

The drug will be delivered via a specially developed spray-on formulation, which was manufactured at Recce's facility. 

Outlook

A previously announced intravenous study will run in parallel to demonstrate the broad administration capabilities of RECCE 327.

Recce Pharmaceuticals Chairman Dr John Prendergast says gaining Human Research Ethics Committee (HREC) approval is an important step.

"Human ethics approval is another milestone for Recce and the clinicians seeking effective treatments to combat the scourge of antibiotic resistant bacteria," the Chairman said.

"Achieving this goal speaks to the dedication of our clinical and research team as we continue to build on our clinical and commercial potential," he concluded.

Recce 327 is being developed for the treatment of blood infections and sepsis derived from E. coli and S. aureus bacteria — including their superbug forms.

The company is working towards developing new classes of synthetic anti-infectives designed to address the urgent global health problems of antibiotic resistant superbugs and emerging viral pathogens.

Recce Pharmaceuticals is trading 4.72 per cent higher for $1.11 at 10:43 am AEDT.

Read the full article on The Market Herald Here