QIDP

Phathom Pharmaceuticals Announces Results from VONO-103, a Phase 1 Study Evaluating Gastric Acid Inhibition of Vonoprazan and Lansoprazole (PREVACID®)

Monday, September 27, 2021 - 1:00pm

FLORHAM PARK, N.J., Sept. 27, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today reported results from VONO-103, a Phase 1 trial evaluating the effects of vonoprazan 20 mg once daily (“QD”) and lansoprazole 30 mg QD in healthy U.S. subjects. In the study, vonoprazan demonstrated significantly greater acid inhibition as compared to lansoprazole. The study treatments were generally well tolerated with no serious adverse events reported.

Key Points: 
  • In the study, vonoprazan demonstrated significantly greater acid inhibition as compared to lansoprazole.
  • The greater gastric acid inhibition was maintained after seven days of once daily dosing.
  • The mean 24-hour pH value on Day 7 for vonoprazan was 5.9 as compared to 3.8 for lansoprazole (p
  • VONO-103 is the first pharmacokinetic and pharmacodynamic (PK/PD) and safety study comparing vonoprazan 20 mg QD and lansoprazole 30 mg QD.

SCYNEXIS to Present Data on Oral Ibrexafungerp at IDWeek 2021 from Interim Analyses of Phase 3 FURI Clinical Trial Showing Therapeutic Response Rates in Patients with Mucocutaneous and Invasive Fungal Infections

Thursday, September 23, 2021 - 1:30pm

The data from these three presentations provide a deeper understanding of ibrexafungerps activity against a broad spectrum of fungal infections caused by Candida species, including azole- and echinocandin-resistant strains.

Key Points: 
  • The data from these three presentations provide a deeper understanding of ibrexafungerps activity against a broad spectrum of fungal infections caused by Candida species, including azole- and echinocandin-resistant strains.
  • We are encouraged by the interim results of the study as we work toward the goal of making ibrexafungerp available to patients with serious fungal infections in the U.S. and around the world.
  • Ibrexafungerp is in late-stage development for multiple indications, including life-threatening fungal infections caused primarily by Candida (including C. auris) and Aspergillus species in hospitalized patients.
  • In addition, late-stage clinical investigation of ibrexafungerp for the prevention of recurrent Vulvovaginal Candidiasis (VVC) and the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing.

SCYNEXIS Announces U.S. Availability of BREXAFEMME® (ibrexafungerp tablets), the First New Antifungal Class of Therapy Approved by the U.S. FDA for Vaginal Yeast Infections in More Than 20 Years

Wednesday, September 22, 2021 - 1:30pm

BREXAFEMME is a truly new, first-in-class fungicidal triterpenoid antifungal, designed to kill the yeast causing the infection, including azole-resistant strains.

Key Points: 
  • BREXAFEMME is a truly new, first-in-class fungicidal triterpenoid antifungal, designed to kill the yeast causing the infection, including azole-resistant strains.
  • As part of its commitment to ensuring patient access, SCYNEXIS has implemented programs to remove potential barriers and help patients receive treatment.
  • Vulvovaginal Candidiasis (VVC), commonly known as a vaginal yeast infection due to Candida, is the second most common cause of vaginitis.
  • All forward-looking statements contained in this press release speak only as of the date on which they were made.

Pulmocide’s lead drug candidate opelconazole (PC945) granted Orphan Drug, Fast Track and Qualified Infectious Disease Product Designations by US FDA

Wednesday, September 15, 2021 - 12:00pm

Pulmocides lead drug candidate opelconazole (PC945) granted Orphan Drug, Fast Track and Qualified Infectious Disease Product Designations by US FDA

Key Points: 
  • Pulmocides lead drug candidate opelconazole (PC945) granted Orphan Drug, Fast Track and Qualified Infectious Disease Product Designations by US FDA
    London, UK; 15 September 2021 Pulmocide Ltd. (the Company), a late-stage biopharmaceutical company focused on the development and commercialization of transformational therapies for patients with severe pulmonary diseases, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug, Fast Track and Qualified Infectious Disease Product designations for opelconazole (PC945) for the treatment of invasive pulmonary aspergillosis (IPA).
  • Fast Track designation is an FDA process designed to facilitate the development, and expedite the review of treatments to treat serious conditions and fill unmet medical needs.
  • Qualified Infectious Disease Product (QIDP) designation provides incentives to drug manufacturers to develop new treatments for serious fungal and antibiotic-resistant bacterial infections.
  • Pulmocides lead product is opelconazole (PC945), a novel antifungal therapy specifically designed for inhaled use to maximize the amount of drug in the lung and spare systemic exposure.

F2G appoints Camilla Soenderby to Board of Directors

Wednesday, September 15, 2021 - 8:00am

MANCHESTER, England, PRINCETON, N.J.and VIENNA, Sept. 15, 2021 /PRNewswire/ -- F2G Ltd, a clinical-stage biopharmaceutical company focused on rare life-threatening fungal diseases with a high unmet medical need, today announces the appointment of Camilla Soenderby as a Non-Executive Director to its Board of Directors with immediate effect.

Key Points: 
  • MANCHESTER, England, PRINCETON, N.J.and VIENNA, Sept. 15, 2021 /PRNewswire/ -- F2G Ltd, a clinical-stage biopharmaceutical company focused on rare life-threatening fungal diseases with a high unmet medical need, today announces the appointment of Camilla Soenderby as a Non-Executive Director to its Board of Directors with immediate effect.
  • Patrick Vink, Chairman of F2G Ltd, said: "On behalf of the whole board I am very pleased to welcome Camilla to F2G.
  • Camilla began her career as a management consultant at McKinsey & Co. focused on the biopharmaceutical and medical devices industries.
  • F2G is a world-leading biotech company focused on the discovery and development of novel therapies to treat life-threatening invasive fungal infections.

F2G appoints Camilla Soenderby to Board of Directors

Wednesday, September 15, 2021 - 8:00am

MANCHESTER, England, PRINCETON, N.J. and VIENNA, Sept. 15, 2021 /PRNewswire/ -- F2G Ltd, a clinical-stage biopharmaceutical company focused on rare life-threatening fungal diseases with a high unmet medical need, today announces the appointment of Camilla Soenderby as a Non-Executive Director to its Board of Directors with immediate effect.   

Key Points: 
  • MANCHESTER, England, PRINCETON, N.J.and VIENNA, Sept. 15, 2021 /PRNewswire/ -- F2G Ltd, a clinical-stage biopharmaceutical company focused on rare life-threatening fungal diseases with a high unmet medical need, today announces the appointment of Camilla Soenderby as a Non-Executive Director to its Board of Directors with immediate effect.
  • Patrick Vink, Chairman of F2G Ltd, said: "On behalf of the whole board I am very pleased to welcome Camilla to F2G.
  • Camilla began her career as a management consultant at McKinsey & Co. focused on the biopharmaceutical and medical devices industries.
  • F2G is a world-leading biotech company focused on the discovery and development of novel therapies to treat life-threatening invasive fungal infections.

Pulmocide’s lead drug candidate opelconazole (PC945) granted Orphan Drug, Fast Track and Qualified Infectious Disease Product Designations by US FDA

Wednesday, September 15, 2021 - 7:00am

Pulmocides lead drug candidate opelconazole (PC945) granted Orphan Drug, Fast Track and Qualified Infectious Disease Product Designations by US FDA

Key Points: 
  • Pulmocides lead drug candidate opelconazole (PC945) granted Orphan Drug, Fast Track and Qualified Infectious Disease Product Designations by US FDA
    London, UK; 15 September 2021 Pulmocide Ltd. (the Company), a late-stage biopharmaceutical company focused on the development and commercialization of transformational therapies for patients with severe pulmonary diseases, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug, Fast Track and Qualified Infectious Disease Product designations for opelconazole (PC945) for the treatment of invasive pulmonary aspergillosis (IPA).
  • Fast Track designation is an FDA process designed to facilitate the development, and expedite the review of treatments to treat serious conditions and fill unmet medical needs.
  • Qualified Infectious Disease Product (QIDP) designation provides incentives to drug manufacturers to develop new treatments for serious fungal and antibiotic-resistant bacterial infections.
  • Pulmocides lead product is opelconazole (PC945), a novel antifungal therapy specifically designed for inhaled use to maximize the amount of drug in the lung and spare systemic exposure.

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.

Positive Results from Phase 3 PROMIS-I Study of CMS I-neb® in Patients with Non-Cystic Fibrosis Bronchiectasis Presented at European Respiratory Society (ERS) Annual Meeting

Wednesday, September 8, 2021 - 12:30pm

The trial explored the effect of CMS I-neb on the frequency of pulmonary exacerbations in NCFB patients chronically infected with P. aeruginosa.

Key Points: 
  • The trial explored the effect of CMS I-neb on the frequency of pulmonary exacerbations in NCFB patients chronically infected with P. aeruginosa.
  • A total of 377 patients were randomized, 177 to CMS I-neb and 200 to placebo.
  • The annual rate of exacerbations was significantly lower in patients receiving CMS I-neb vs placebo (0.58 per patient per year vs 0.95, rate ratio (RR) 0.61 95% CI 0.46-0.82, p=0.00101).
  • These results are encouraging for patients as there is currently no approved drug treatment for this indication.