Recce Pharmaceuticals Announces Safety Committee Clears Next Dose in Phase I Study of RECCE® 327
Highlights:
- Independent Safety Committee unanimously recommends cohort four (RECCE® 327 at 1,000mg) to commence; a 20-fold increase from cohort one dose (50mg)
- Cohort four subjects recruited – RECCE® 327 at 1,000mg dosing started on March 7, 2022
- All subjects to be intravenously dosed this week
SYDNEY, Australia, March 08, 2022 (GLOBE NEWSWIRE) — Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q) (the Company), the Company developing new classes of synthetic anti-infectives, is pleased to report an Independent Safety Committee data review of 10 healthy human subjects intravenously dosed in the Phase I intravenous (IV) clinical trial of RECCE® 327 (R327), demonstrating a good safety and tolerability profile – unanimously recommending cohort four (R327, 1,000mg IV) to commence.
“Recommendation to start IV dosing of cohort four (R327 IV; 1,000mg) is a wonderful endorsement for the compelling safety and tolerability profile demonstrated among 10 subjects of cohort three,” said James Graham, Chief Executive Officer of Recce Pharmaceutical. “With subjects in cohort four recruited and dosing starting yesterday, we are on-track to complete cohort four doing this week.”
The Phase I trial is an ascending dose, randomized, placebo-controlled, parallel, double-blind, single-dose study being conducted at Adelaide’s CMAX clinical trial facility. The study is evaluating the safety and pharmacokinetics of R327 in 7-10 healthy male subjects per dose, across eight sequential dosing cohorts of 50-16,000mg (Trial ID ACTRN12621001313820). The study is on track to have all Phase I dosing complete by Q2 2022.
According to PEW Charitable Trusts global antibiotic pipeline review, R327 is the only clinical-stage new class of antibiotic in the world being developed for sepsis, the largest unmet medical need in human health.1
About Recce Pharmaceuticals Ltd
Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is developing a New Class of Synthetic Anti-Infectives designed to address the urgent global health problems of antibiotic-resistant superbugs and emerging viral pathogens.
Recce’s anti-infective pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives: RECCE® 327 as an intravenous and topical therapy that is being developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria including their superbug forms; RECCE® 435 as an orally administered therapy for bacterial infections; and RECCE® 529 for viral infections. Through their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to overcome the hypercellular mutation of bacteria and viruses – the challenge of all existing antibiotics to date.
The FDA has awarded RECCE® 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labelling it for Fast Track Designation, plus 10 years of market exclusivity post approval. Further to this designation, RECCE® 327 has been included on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline as the world’s only synthetic polymer and sepsis drug candidate in development. RECCE® 327 is not yet market approved for use in humans with further clinical testing required to fully evaluate safety and efficacy.
Recce wholly owns its automated manufacturing, which is supporting present clinical trials. Recce’s anti-infective pipeline seeks to exploit the unique capabilities of its technologies targeting synergistic, unmet medical needs.
Corporate Contact
James Graham
Recce Pharmaceuticals Ltd
+61 (02) 8075 4585
James.graham@recce.com.au
Media and Investor Relations (AU)
Andrew Geddes
CityPR
+61 (02) 9267 4511
ageddes@citypublicrelations.com.au
Media and Investor Relations (USA)
Jordyn Temperato
LifeSci Communications
jtemperato@lifescicomms.com
1 https://www.pewtrusts.org/en/research-and-analysis/data-visualizations/2017/nontraditional-products-for-bacterial-infections-in-clinical-development
