MedPath

Ibezapolstat

Generic Name
Ibezapolstat
Brand Names
-
Drug Type
Small Molecule
Chemical Formula
C18H20Cl2N6O2
CAS Number
1275582-97-2
Unique Ingredient Identifier
5K543KNC5P
Background

Ibezapolstat is under investigation in clinical trial NCT04247542 (ACX-362E Ibezapolstat for Oral Treatment of Clostridioides Difficile Infection).

Associated Conditions
-
Associated Therapies
-
pharmabiz.com
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Acurx Pharma receives positive regulatory guidance from EMA for ibezapolstat phase 3

Acurx Pharmaceuticals received positive EMA guidance for its ibezapolstat phase 3 programme, supporting advancement with clinical, non-clinical, and CMC data. The phase 3 trials aim to demonstrate non-inferiority to vancomycin, with a focus on Clinical Cure and reducing CDI recurrence. Ibezapolstat, a novel antibiotic, showed a 96% Clinical Cure rate in phase 2 trials, with favorable microbiome changes and secondary bile acid increases suggesting anti-recurrence potential. Acurx plans international phase 3 trials, leveraging FDA's QIDP and Fast Track designations for CDI treatment.
pharmabiz.com
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Acurx Pharma receives positive regulatory guidance from EMA for ibezapolstat phase 3 programme for C. difficile infection

Acurx Pharmaceuticals received positive EMA guidance for its ibezapolstat phase 3 programme, aiming to treat C. difficile infections. The phase 3 trials will compare ibezapolstat to vancomycin, focusing on clinical cure and recurrence reduction. Ibezapolstat showed a 96% cure rate in phase 2 trials, with favorable microbiome changes and safety profile.
marketscreener.com
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Acurx Pharmaceuticals, Inc. Announces $2.5 Million Registered Direct Offering

Acurx Pharmaceuticals announced a $2.5 million registered direct offering of 2,463,058 shares at $1.015 each, alongside private placement warrants. Proceeds aim for working capital and general corporate use. The company focuses on developing antibiotics for resistant bacterial infections, with ibezapolstat as a lead candidate.
advfn.com
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Acurx Pharmaceuticals, Inc. Announces Closing of $2.5 Million Registered Direct Offering

Acurx Pharmaceuticals closed a $2.5M registered direct offering of 2,463,058 shares at $1.015 each, with warrants for additional shares. Funds will support working capital and corporate purposes. The company focuses on developing antibiotics for resistant bacterial infections, with a lead candidate, ibezapolstat, nearing Phase 3 trials.
investing.com
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Acurx gains EMA support for ibezapolstat Phase 3 trial

Acurx Pharmaceuticals received EMA's positive feedback for ibezapolstat, advancing it to Phase 3 trials for CDI. Despite a 77% stock decline, it gained 9% YTD. Ibezapolstat, with FDA QIDP and Fast-Track Designation, showed a 96% cure rate in Phase 2. Acurx plans international trials and holds a strong financial position.
morningstar.com
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Acurx Receives Positive Regulatory Guidance from EMA for Ibezapolstat Phase 3 Program

Acurx Pharmaceuticals received positive regulatory guidance from the EMA for its ibezapolstat Phase 3 program targeting C. difficile Infection (CDI), supporting its advancement. The company is preparing for international Phase 3 trials, with plans to seek regulatory guidance in Japan, Canada, and the UK. Ibezapolstat has FDA QIDP and Fast-Track Designation.
stocktitan.net
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Acurx's Ibezapolstat Secures EMA Backing for Phase 3 C. Difficile Treatment Program

Acurx Pharmaceuticals received EMA's positive feedback for ibezapolstat's Phase 3 program for CDI treatment, aligning with FDA's guidance. Plans include international Phase 3 trials in Japan, Canada, and the UK, following successful Phase 2 trials showing high efficacy and safety.
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