AUS
NZ
UK
CA
USA
IND
Highlights
- Recce Pharmaceuticals’ R327 exhibits a safe and tolerable profile.
- The safety profile of R327 at a twenty-fold increase of the initial dosing level is crucial for synergies across the company’s wider-infectious disease portfolio.
- R327 has received the Qualified Infectious Disease Product designation from the US FDA.
Recce Pharmaceuticals Ltd (ASX:RCE) has achieved a milestone, recording positive safety data from the fourth cohort of Phase I clinical trial of RECCE® 327 (R327) at 1,000mg.
Recce is a healthcare company focused on developing New Classes of Synthetic Anti-Infectives. Its pipeline includes the following three anti-infectives:
- RECCE® 327 – for infections due to Gram-positive and Gram-negative bacteria
- RECCE® 435 – for bacterial infections
- RECCE® 529 – for viral infections.
All these are patented, broad-spectrum, and synthetic polymer anti-infectives.
Must Read: From IMC to ALA: Healthcare stocks with best YTD returns
RECCE® 327 exhibits a safe and tolerable profile
The Phase I intravenous (IV) clinical trial of RECCE® 327 (R327) Cohort Four at 1,000mg (a twenty-fold increase on cohort one 50mg dose) indicated a good safety and tolerability profile among 10 healthy male subjects. None of the subjects showed clinically significant changes in vital signs or adverse events.
The study conducted at Adelaide’s CMAX clinical trial facility had the following features:
- Ascending dose and single dose
- Placebo-controlled
- Randomised
- Double-blind
The study is on a good course and is expected to see the completion of all Phase 1 dosing by Q2 2022.
Image source: © Designua | Megapixl.com
Must Read: ACW, HXL, IMM – ASX biotech stocks that gained over 25% in 52 weeks
According to PEW Charitable Trusts global antibiotic pipeline review, R327 is the only clinical-stage new class of antibiotic globally being developed for sepsis, which is the largest unmet medical need in human health.
More about R327
RECCE® 327 is an intravenous and topical therapy. It is targeted to cure serious and potentially fatal infections due to Gram-positive and Gram-negative bacteria and their superbug forms. It has achieved some important designations such as:
- Qualified Infectious Disease Product designation from the United States Food and Drug Administration (FDA)
- Fast Track Designation and additional 10 years of market exclusivity post approval.
RECCE® 327 is yet to secure market approval for human use. It will require additional clinical trials to fully evaluate safety and efficacy.
Stock information
Recce Pharmaceuticals has a market capitalisation of AU$165.33 million. At the time of writing this article on 30 March 2022, RCE shares were trading at AU$0.955, up 0.526% from the last close.
Also read: Reece (ASX:RCE) shares near 52-week high, here’s why?
