Need to push the IV dose higher, page-27

June - August. This is all looking good to me. As indicated in June announcement, successful trial here will lead to next stop being use in actual UTI patients initiated and possibly even completed in CY23. No point doing that if it is not going to be effective. If it is effective we are likely to see a new era beginning.

Recce Pharmaceuticals Receives Ethics Approval for RECCE®327 Faster Infusion, Phase I/II Clinical Trial Expansion

Highlights:

• The Faster Infusion, Phase I/II UTI Intravenous (IV) study dosing at CMAX

  Clinical Research expands to Scientia Clinical Research

• Human Research Ethics Committee approval allows for further dosing at Scientia Clinical Research, broadening patient population across multiple

  world class facilities

  Sydney Australia, 29 June 2023:Recce Pharmaceuticals Limited (ASX:RCE, FSE:R9Q), the Company developing a New Class of Synthetic Anti-Infectives, is pleased to announce it has received approval from the Human Research Ethics Committee (HREC) to expand its Faster Infusion, Phase I/II Urinary Tract Infections (UTI) intravenous clinical trial of its lead product, RECCE®327 (R327), to Scientia Clinical Research.

  The clinical trial is assessing R327 at faster administration rates, potentially applicable for use at first patient presentation within a GP or Acute patient setting. R327 will be administered in approximately 16 participants as a broad spectrum anti-infective across the full spectrum of UTIs (simple, complicated & recurring), with a Phase II in UTI patients expected to be initiated H2 CY23.

  Scientia Clinical Research is an FDA audited world-class clinical trials facility in Sydney, New South Wales, Australia, specialising in first-in-human and first-in-patient studies, as well as single and multiple dose studies, food effect studies, drug interaction studies, ethnopharmacology, formulation studies. It is co-located in a major research precinct with Prince of Wales Hospital, Royal Hospital for Women, UNSW and the Lowy Cancer Research Centre.

  Chief Executive Officer James Graham said: “We are pleased to expand our Phase I/II UTI studies with Scientia Clinical Research (NSW) joining present dosing at CMAX (SA). This now multistate study expects to expedite our clinical trial progress and address the global health threats posed by UTIs and Urosepsis.”

Scientia Clinical Research Completes Cohort Dosing of Phase I/II UTI Rapid Infusion Clinical Trial

Highlights:

• Scientia Clinical Research complete cohort dosing ahead of schedule

• RECCE®327 safe and well tolerated in male and female subjects at two faster

  infusion rates of 2,500mg rates via I.V administration

• Independent Safety Committee to review cohort data – subject recruitment for

  next cohort underway

  SYDNEY Australia, 28 July 2023:Recce Pharmaceuticals Ltd (ASX:RCE,FSE:R9Q) (theCompany), the Company developing a new class of Synthetic Anti-infectives, is pleased to report Scientia Clinical Research has successfully completed cohort dosing of both male and female subjects in its Phase I/II UTI clinical trial evaluating RECCE®327 (R327) at faster infusion rates.

  R327 was shown to be safe and well tolerated at two faster infusion rates of 2,500mg, with an Independent Safety Committee reviewing complete cohort dosing data, expected to recommend go ahead, with recruitment well underway.

  Chief Executive Officer James Graham said, “R327 via two faster infusion rates of 2,500mg across male and female subjects continues to be shown as safe and well tolerated. Completing dosing well ahead of schedule is a welcomed confirmation that we are on track in achieving study objectives”

  Full details on the trial can be found on anzctr.org.au under the Trial ID ACTRN12623000448640.

Safety Committee Approves Next Dose of 3,000mg in Phase I/II UTI/Urosepsis Rapid Infusion Clinical Trial

Highlights:

• Independent Safety Committee approves next Cohort dosing of RECCE®327

  (R327) at two faster infusion rates of 3,000mg via I.V. administration

• Independent Safety Committee unanimously agreed R327 is safe and well tolerated in male and female subjects at two faster infusion rates of 2,500mg

  via I.V. administration

• Next Cohort of subjects recruited – subject dosing to begin imminently

  SYDNEY Australia, 28 August 2023:Recce Pharmaceuticals Ltd (ASX:RCE,FSE:R9Q) (theCompany), the Company developing a new class of Synthetic Anti-infectives, is pleased to report an Independent Safety Committee approved next cohort dosing at two faster infusion rates of 3,000mg. Furthermore, the committee unanimously agreed R327 at two faster infusion rates of 2,500mg is safe and well tolerated in male and female subjects. The next cohort of subjects have been recruited with dosing to begin imminently.

  Chief Executive Officer of Recce Pharmaceuticals James Graham said “We are pleased to receive the go-ahead by the Independent Safety Committee to commence dosing of R327 at two faster infusion rates of 3,000mg. This reaffirms the committee’s view that R327 is safe and well tolerated at two faster infusion rates of 2,500mg. Results from this trial will pave the way for R327 as a potential first-line treatment for patients suffering from UTI/Urosepsis.”

  UTI’s are responsible for about 30% of all sepsis infections, defined as ‘Urosepsis’1. R327’s potential as a treatment option across the patient infectious disease journey (underlying infection>septic state) positions it for therapy in this area of unmet medical need. More information on this trial can be found at the Australia New Zealand Clinical Trial Registry under the trial ID ACTRN12623000448640.