reports
- Sean Conroy
Recce Pharmaceuticals - BPOM clearance to start Phase III R327G study
Recce received approval from the Indonesian Drug and Food Regulatory Authority, Badan POM (BPOM), to start its registrational Phase III study in Indonesia of RECCE® 327 topical gel (R327G) in diabetic foot infections (DFIs). This was the final hurdle that needed to be overcome before study enrolment can proceed, which is expected to start before the end of 2024. Top-line data from the 300-patient double-blinded Phase III study (with 200 patients in the R327 arm and 100 on placebo) are anticipate...
Recce Pharmaceuticals Receives Approval from Indonesia’s Drug and Food...
Recce Pharmaceuticals Receives Approval from Indonesia’s Drug and Food Authority for Registrational Phase 3 Trial of RECCE® 327 Topical Gel in Diabetic Foot Infections Registrational Phase 3 trial for diabetic foot infections to be conducted across Indonesia, one of the world's largest diabetes patient populationsAwarded expedited regulatory review status in Indonesia to fast-track progression of Phase 3 trial, bringing forward commercial opportunities in ASEAN region SYDNEY, Dec. 10, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q), (Recce or the Company), the C...
- Sean Conroy
Recce Pharmaceuticals - Topical R327G approaching pivotal stages
Recce Pharmaceuticals has made several strides in advancing its topical gel formulation (R327G) of lead anti-infective therapeutic drug candidate RECCE® 327 (R327) as a topical treatment for acute bacterial skin and skin structure infections (ABSSSI) and diabetic foot infections (DFIs). The company received Human Research Ethics Committee (HREC) approval to start a registrational Phase III DFI study in Indonesia, which, if successful, could lead to a commercial launch in South-East Asia in CY26....
Recce Pharmaceuticals Granted Australia Patent for RECCE® Anti-Infecti...
Recce Pharmaceuticals Granted Australia Patent for RECCE® Anti-Infectives SYDNEY, Nov. 27, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q), the Company developing a new class of synthetic anti-infectives, today announced the Australian Patent Office has formally granted Recce a family three patent for its anti-infectives, with expiry in 2037. “We are thrilled by the Australian Patent Office’s formal recognition of the ground-breaking potential of Recce’s New Class of Anti-Infectives,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “The gran...
Recce Pharmaceuticals Receives Ethics Approval in Indonesia to Commenc...
Recce Pharmaceuticals Receives Ethics Approval in Indonesia to Commence Registrational Phase 3 Trial of RECCE® 327 Topical Gel in Diabetic Foot Infections Human Research Ethics Committee approval received for registrational Phase 3 trial for RECCE® 327 topical gel in patients with diabetic foot infectionsRegistrational Phase 3 clinical trial for diabetic foot infections to be conducted across Indonesia, one of the world's largest diabetes patient populationsData read-out and regulatory submission expected in late 2025 with potential approval and commercial launch in H1 2026Bilateral initiat...
Recce Pharmaceuticals Advances Patient Dosing to Final Stages in Phase...
Recce Pharmaceuticals Advances Patient Dosing to Final Stages in Phase II Trial for Acute Bacterial Skin and Skin Structure Infections Trial reaches dosing milestone, with 20 of the 30 total patients dosedAll patients dosed met the primary endpoints of the study, either a cure or notable improvement following treatment with RECCE® 327 topical gel (R327G)Patient dosing on track to be completed by the end of 2024 SYDNEY, Nov. 06, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q), (Recce or the Company), the Company developing a new class of synthetic anti-infectives, to...
Recce Pharmaceuticals Announces Interim Efficacy Data and Safety Appro...
Recce Pharmaceuticals Announces Interim Efficacy Data and Safety Approval for Phase II ABSSSI Clinical Trial RECCE® 327 Topical Gel (R327G) was demonstrated to be safe and well-tolerated in patients – R327G demonstrating highly encouraging efficacy results as determined by non-Data Safety Monitoring BoardAll patients completing treatment with R327G met the primary endpoint of complete cure or improvement, seen as early as 7 daysNo Serious Adverse Events noted in patients - recommendation for clinical trial to continue, reflecting promising potential of R327G as a safe and effective treatmen...
Recce Pharmaceuticals Announces Recruitment Passes Halfway in Phase II...
Recce Pharmaceuticals Announces Recruitment Passes Halfway in Phase II Trial for Acute Bacterial Skin and Skin Structure Infections Phase II trial assessing the efficacy of RECCE® 327 topical gel (R327G) against acute bacterial skin and skin structure infectionsR327G demonstrating promising antibacterial effect across a broad range of human infectionsClinical study review board on track for mid-October, with interim results to followTrial study locations expand across New South Wales (NSW) and Victoria, broadening access to this potentially novel approach SYDNEY, Oct. 10, 2024 (GLOBE NEW...
Recce Pharmaceuticals Announces Successful Completion of Share Purchas...
Recce Pharmaceuticals Announces Successful Completion of Share Purchase Plan A$4.4 million of valid applications received for the Share Purchase PlanIn conjunction with recently completed A$8.0 million institutional placement, total amount raised is A$12.4 millionProceeds will be used to advance clinical trials for intravenous use of R327, topical applications of R327G, including Phase III clinical activities in Indonesia, and IND-enabling activitiesPro forma cash position of A$19.8 million SYDNEY, Aug. 06, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) (Recc...
Recce Pharmaceuticals Receives $2 Million Grant from U.S. Department o...
Recce Pharmaceuticals Receives $2 Million Grant from U.S. Department of Defense for RECCE® 327 Gel Funding to accelerate development of RECCE® 327 Gel (R327G) for acute treatment of burn wound infections and downstream bacterial complications such as sepsis in a military settingR327G to be evaluated as a potential replacement for traditional antimicrobial dressings and topicals used in the military setting SYDNEY, July 16, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q), (Recce or the Company), the Company developing a new class of synthetic anti-infectives, tod...
- Sean Conroy
Recce Pharmaceuticals - Taking a closer look at diabetic foot infectio...
We highlight the opportunity of topical RECCE® 327 (R327) to address diabetic foot infections (DFIs), which is the leading cause of limb morbidity in diabetic patients and an area of unmet need as currently available topical drugs have limited effectiveness. Recce is planning to initiate a Phase III registration-enabling study in H2 CY24 in Indonesia. We anticipate that positive results from the trial could lead to Recce’s earliest R327 commercialisation opportunity, through a launch in South-Ea...
Recce Pharmaceuticals Announces Positive Preclinical Efficacy Data Aga...
Recce Pharmaceuticals Announces Positive Preclinical Efficacy Data Against WHO Priority Pathogen Acinetobacter baumannii RECCE® 327 (R327) demonstrated significant bactericidal activity against ‘superbug’ Acinetobacter baumannii (A. baumannii) demonstrating 99.99999% log reduction (>7.5 log reduction) in adult human epidermal ‘skin’ cellsA. baumannii is most commonly responsible for urinary tract infections, ventilator-associated pneumonia, central line-associated bloodstream infections, persistent wound infections and meningitisThe data supports upcoming Phase II Acute Bacterial Skin and S...
Recce Pharmaceuticals Reports Positive Data from Phase I/II Urinary Tr...
Recce Pharmaceuticals Reports Positive Data from Phase I/II Urinary Tract Infection (UTI) / Urosepsis Rapid Infusion Trial of RECCE® 327 Results demonstrate efficacy on bacterial growth in participants injected with RECCE® 327 (R327) at the highest tested dose of 4,000mgNo serious adverse events and clinically significant changes observed, reinforcing safety profile of R327The study determined an optimal dosing regimen for R327 intravenously, showing rapid onset and sustained impact on Escherichia coli via an ATP mechanism in the urine of dosed participantsRecce on track to initiate Phase I...
Recce Pharmaceuticals Receives Ethics Approval to Broaden RECCE® 327 G...
Recce Pharmaceuticals Receives Ethics Approval to Broaden RECCE® 327 Gel Trials Across all Topical Bacterial Skin Infections Positions RECCE® 327 (R327) gel as a potential broad topical therapeutic for all bacterial skin infectionsHuman Research Ethics Committee approval received for Phase II trial of R327 for acute bacterial skin and skin structure infections (ABSSSI), including diabetic foot and wound infectionsNew site initiation commenced with first patients to be dosed in Q3 2024This trial builds upon clinical results of R327 tested against burn wound and diabetic foot infections SY...
Recce Pharmaceuticals Announces Addition of RECCE® 327 to The World He...
Recce Pharmaceuticals Announces Addition of RECCE® 327 to The World Health Organization’s List of Antibacterial Products in Clinical Development Inclusion underscores significance of RECCE® 327 (R327) in combating antimicrobial resistance and its potential to treat broad range of life-threatening and resistant bacteria SYDNEY, June 20, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) (the Company), the Company developing a new class of synthetic anti-infectives, today announced its primary anti-infective candidate, RECCE® 327 (R327), has been added to the World He...
Recce Pharmaceuticals Completes Dosing Additional Cohort in Phase I/II...
Recce Pharmaceuticals Completes Dosing Additional Cohort in Phase I/II UTI/Urosepsis Rapid Infusion Trial Six additional participants intravenously dosed with RECCE® 327 (R327) at 4,000mg over 20 minutes – highest dosage to date in this trial SYDNEY, June 12, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd. (ASX:RCE, FSE:R9Q), (the Company), the Company developing a new class of synthetic anti-infectives, today announced it completed dosing an additional cohort in its Phase I/II UTI/Urosepsis trial, evaluating RECCE® 327 (R327) at fast infusion rates. "We have successfully reached a...
Recce Pharmaceuticals Doses First Participants in Next Cohort of Phase...
Recce Pharmaceuticals Doses First Participants in Next Cohort of Phase I/II Urinary Tract Infections and Urosepsis Rapid Infusion Clinical Trial First participants (male/female) dosed at 4,000mg over 20 minutes, with remaining subjects to be dosed in the near future - 4,000mg highest dosage to date in this clinical trialRECCE® 327 (R327) tested at four fast IV infusion times (15-mins, 20-mins, 30-mins, 45-mins) over various dosage levelsMinimum Inhibitory Concentration (MIC) activity against bacteria already identified among existing clinical samples, a dose optimization exercise for regula...
Recce Pharmaceuticals Reports Positive Preclinical Data of RECCE® 327 ...
Recce Pharmaceuticals Reports Positive Preclinical Data of RECCE® 327 in Lung Infection Pilot Study RECCE® 327 (R327) demonstrated >99% log reduction (>2.5 log reduction) in Mycobacterium abscessus lung infections using a nebulizer delivery methodR327 is being evaluated for potential use to treat ventilator-associated pneumonia (VAP) and hospital-acquired pneumonia (HAP) SYDNEY, Australia, May 13, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd. (ASX: RCE, FSE: R9Q) (the Company), the Company developing a new class of synthetic anti-infectives, today announced positive results from a ...
Recce Pharmaceuticals Granted New Patent in China for RECCE® Anti-Infe...
Recce Pharmaceuticals Granted New Patent in China for RECCE® Anti-Infectives SYDNEY, Australia, May 08, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd. (ASX: RCE, FSE: R9Q), the Company developing a new class of synthetic anti-infectives, today announced the China National Intellectual Property Administration has formally granted Recce a new family two patent, “Copolymer and Method for Treatment of Bacterial Infection,” for its anti-infectives, with expiry in 2035. “We thank the China National Intellectual Property Administration for their recognition of the significant potenti...
- Sean Conroy
Recce Pharmaceuticals - Advances on several fronts
Recce Pharmaceuticals has reported several encouraging developments in recent weeks for its lead development compound RECCE® 327 (R327). The intravenous (IV) R327 formulation is advancing to a higher dose level (4,000mg) in its ongoing Phase I/II rapid infusion study and the company is progressing in its plan to submit a US Investigational New Drug (IND) application to commence a US Phase II complicated urinary tract infection (cUTI) study before end-CY24. Recce is also planning to start an Indo...
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