Ridinilazole

CEO Spotlight: Acurx Pharmaceuticals in Focus with CEO David Luci Talking Potentially Transformative Phase 2b Trial, Pipeline, and Potential Near-Term Catalysts

Monday, September 13, 2021 - 2:48pm

Acurx Pharmaceutical's CEO tells Soulstring Media why he thinks 2021-22 can be a breakout year for his company

Key Points: 
  • Rather than speculate on each drug's market potential, HPM reached out to Mr. David Luci, CEO of Acurx, allowing him to respond to investor questions.
  • Acurx is outside that mold because we have a new class of antibiotics treating life-threatening infections with two in the class.
  • Our scientific team has indicated publicly that these data portend future success in Phase 2b and Phase 3.
  • Q: The Phase 2b trial can be transformative to Acurx, especially if data proves superior to standard of care Vancomycin in the imminent head-to-head match-up.

CEO Spotlight: Acurx Pharmaceuticals in Focus with CEO David Luci Talking Potentially Transformative Phase 2b Trial, Pipeline, and Potential Near-Term Catalysts

Monday, September 13, 2021 - 1:03pm

Acurx Pharmaceutical's CEO tells Soulstring Media why he thinks 2021-22 can be a breakout year for his company

Key Points: 
  • Rather than speculate on each drug's market potential, HPM reached out to Mr. David Luci, CEO of Acurx, allowing him to respond to investor questions.
  • Acurx is outside that mold because we have a new class of antibiotics treating life-threatening infections with two in the class.
  • Our scientific team has indicated publicly that these data portend future success in Phase 2b and Phase 3.
  • Q: The Phase 2b trial can be transformative to Acurx, especially if data proves superior to standard of care Vancomycin in the imminent head-to-head match-up.

Summit Therapeutics Presents Breakthrough Research Data from Phase II Studies, including Evidence Validating Microbiome Preservation, for its Investigational Drug Ridinilazole

Monday, July 12, 2021 - 1:29pm

Ridinilazole is Summit Therapeutics investigational first-in-class drug currently in two pivotal Phase III Ri-CoDIFy clinical trials.

Key Points: 
  • Ridinilazole is Summit Therapeutics investigational first-in-class drug currently in two pivotal Phase III Ri-CoDIFy clinical trials.
  • In a Phase II study, treatment with ridinilazole compared to vancomycin demonstrated a significant sparing effect on the gut microbiome, supporting the production of protective secondary bile acids.
  • This is believed to be the primary mechanism through which ridinilazole elicits its bactericidal action against C. difficile bacteria.
  • The combination of these studies and discoveries provide us with further data in support of the intended efficacy of ridinilazole.

Acurx Announces New Ibezapolstat Data on Anti-Recurrence Mechanisms in CDI at Prominent International Conference

Thursday, July 1, 2021 - 1:00pm

This hypothesis will be tested in the Phase 2b trial of ibezapolstat in the treatment of patients with CDI.

Key Points: 
  • This hypothesis will be tested in the Phase 2b trial of ibezapolstat in the treatment of patients with CDI.
  • Having such potentially predictive data so early in development could create a new paradigm for CDI drug development."
  • Background: Reduction in likelihood of Clostridioides difficile infection (CDI) recurrence is an essential endpoint for antibiotics in development for CDI although it is often not evaluated until Phase 3 trials.
  • Advancing knowledge of microbiome, functional metagenomics, and metabolomics may enable predictions of anti-recurrence effects earlier in the drug development process.

RedHill Biopharma's RHB-204 Granted FDA Fast Track Designation for NTM Disease

Wednesday, January 6, 2021 - 12:00pm

With the Fast Track designation, RedHill will have access to early and frequent communications with the FDA, to expedite the RHB-204 development program, and to a rolling review of a New Drug Application (NDA).

Key Points: 
  • With the Fast Track designation, RedHill will have access to early and frequent communications with the FDA, to expedite the RHB-204 development program, and to a rolling review of a New Drug Application (NDA).
  • Having already been granted Qualified Infectious Disease Product (QIDP) designation, RHB-204 is also eligible for NDA Priority Review and Accelerated Approval.
  • RHB-204 was also recently granted Orphan Drug designation, extending U.S. market exclusivity for RHB-204 to a potential total of 12 years upon FDA approval.
  • In addition to FDA Fast Track designation, RHB-204 has been granted FDA Orphan Drug designation for the treatment of NTM disease and QIDP Designation under the Generating Antibiotic Incentives Now Act (GAIN Act), extending U.S. market exclusivity for RHB-204 to a potential total of 12 years to be granted at the time of FDA approval.

RedHill Biopharma's RHB-204 Granted FDA Fast Track Designation for NTM Disease

Wednesday, January 6, 2021 - 12:00pm

With the Fast Track designation, RedHill will have access to early and frequent communications with the FDA, to expedite the RHB-204 development program, and to a rolling review of a New Drug Application (NDA).

Key Points: 
  • With the Fast Track designation, RedHill will have access to early and frequent communications with the FDA, to expedite the RHB-204 development program, and to a rolling review of a New Drug Application (NDA).
  • Having already been granted Qualified Infectious Disease Product (QIDP) designation, RHB-204 is also eligible for NDA Priority Review and Accelerated Approval.
  • RHB-204 was also recently granted Orphan Drug designation, extending U.S. market exclusivity for RHB-204 to a potential total of 12 years upon FDA approval.
  • In addition to FDA Fast Track designation, RHB-204 has been granted FDA Orphan Drug designation for the treatment of NTM disease and QIDP Designation under the Generating Antibiotic Incentives Now Act (GAIN Act), extending U.S. market exclusivity for RHB-204 to a potential total of 12 years to be granted at the time of FDA approval.

Summit Announces Publication of Phase 2 Clinical Analyses of Gut Microbiome Health

Monday, July 13, 2020 - 12:00pm

The protective gut environment observed after ridinilazole treatment, compared to vancomycin, provides a strong rationale for the higher sustained clinical response observed in patients taking ridinilazole in the CoDIFy clinical trial.

Key Points: 
  • The protective gut environment observed after ridinilazole treatment, compared to vancomycin, provides a strong rationale for the higher sustained clinical response observed in patients taking ridinilazole in the CoDIFy clinical trial.
  • The Phase 2 clinical trial enrolled 100 patients, half of whom received ridinilazole and the other half vancomycin.
  • These results support the data from the Phase 2 clinical trial, in which patients receiving ridinilazole showed a statistically significant improvement in sustained clinical responses.
  • Ridinilazole was also shown to be highly preserving of the gut microbiome in the Phase 2 proof of concept trial.

Summit Therapeutics to Receive $1.0 Million Milestone Payment from Eurofarma

Thursday, February 6, 2020 - 12:00pm

Oxford, UK, and Cambridge, MA, US, 6 February 2020 Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM) today announced that it achieved the first milestone under its license and collaboration agreement with Eurofarma Laboratrios SA (Eurofarma).

Key Points: 
  • Oxford, UK, and Cambridge, MA, US, 6 February 2020 Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM) today announced that it achieved the first milestone under its license and collaboration agreement with Eurofarma Laboratrios SA (Eurofarma).
  • The $1.0 million milestone payment was triggered by Summit achieving its initial patient enrolment target at trial sites in Latin America in the Phase 3 clinical trials of ridinilazole for C. difficile infection (CDI).
  • CDI is a global issue caused largely by broad spectrum antibiotic-induced imbalances in the healthy gut microbiome.
  • Eurofarma is an ideal partner for us with the necessary expertise to successfully market ridinilazole in Latin America, should it receive approval.

Summit Therapeutics Reports New Data from Phase 2 Clinical Trial Connecting Ridinilazole’s Microbiome Preservation to Improved Clinical Outcomes for Patients with C. difficile Infection

Monday, October 7, 2019 - 12:00pm

Bile acids exist in different forms that can either favour or block the regrowth of C. difficile after treatment.

Key Points: 
  • Bile acids exist in different forms that can either favour or block the regrowth of C. difficile after treatment.
  • By contrast, ridinilazole leaves these bacteria unharmed, allowing them to keep converting pro-C. difficile bile acids into anti-C. difficile bile acids, maintaining a positive chemical balance that prevents C. difficile recurrence.
  • The Phase 2 clinical trial enrolled 100 patients, half of whom received ridinilazole and the other half vancomycin.
  • These results support the data from the Phase 2 clinical trial, in which patients receiving ridinilazole showed a statistically significant improvement in sustained clinical responses.

Summit Therapeutics Reports Ridinilazole Significantly Improved Short and Longer-Term Quality of Life Measures in Patients with C. difficile Infection Compared to Standard of Care

Thursday, October 3, 2019 - 12:00pm

Our Phase 2 clinical trial documented significant early and longer-term improvements in patient quality of life over the current standard of care, commented Dr David Roblin, President of R&D of Summit.

Key Points: 
  • Our Phase 2 clinical trial documented significant early and longer-term improvements in patient quality of life over the current standard of care, commented Dr David Roblin, President of R&D of Summit.
  • The Phase 2 clinical trial called CoDIFy evaluated ridinilazole compared to vancomycin in 100 patients with CDI.
  • The EQ-5D-3L is a standard measure of health status which evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
  • By Day 40, patients treated with ridinilazole had improved significantly more than vancomycin in anxiety and depression.