Cutis verticis gyrata

Venatorx Pharmaceuticals Announces FDA Acceptance and Priority Review of New Drug Application for Cefepime-Taniborbactam to Treat Complicated Urinary Tract Infections (cUTI), including Pyelonephritis, in Adults

Retrieved on: 
Tuesday, August 15, 2023
Health, FDA, Infectious Diseases, Clinical Trials, Research, Science, Pharmaceutical, Priority review, Senior, Pyelonephritis, Medicine, Infection, New Drug Application, NDA, Cutis verticis gyrata, Prescription Drug User Fee Act, Cutis, Medication, Urinary tract infection, Genetically modified bacteria, Patient, Test, PDUFA, Viral, Meropenem, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry

The FDA previously granted Qualified Infectious Disease Product and Fast Track designations to cefepime-taniborbactam.

Key Points: 
  • The FDA previously granted Qualified Infectious Disease Product and Fast Track designations to cefepime-taniborbactam.
  • The FDA has granted Priority Review of the NDA with a Prescription Drug User Fee Act (PDUFA) target action date of February 22, 2024.
  • “The NDA acceptance represents the culmination of unwavering dedication, scientific excellence, and the collaborative efforts of our talented team, partners, and clinical investigators,” said Christopher J. Burns, Ph.D., Chief Executive Officer of Venatorx.
  • “Patients with cUTIs, including pyelonephritis, and their healthcare providers should have a new treatment option when confronted with infections due to these antibacterial resistant infections.”

Spero Therapeutics Announces Special Protocol Assessment Agreement with FDA for Phase 3 PIVOT-PO Trial of Tebipenem HBr

Retrieved on: 
Monday, July 31, 2023
GSK, IV, Prevalence, HBR, Pyelonephritis, Cutis verticis gyrata, AP, MDR, Patient, SPA, Infection, Rare, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, Spero

CAMBRIDGE, Mass., July 31, 2023 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying, developing and commercializing treatments in areas of high unmet need involving rare diseases and multi-drug resistant (MDR) bacterial infections, announced today that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design and size of PIVOT-PO, a pivotal Phase 3 clinical trial of tebipenem HBr in patients with complicated urinary tract infection (cUTI), including acute pyelonephritis (AP).

Key Points: 
  • “PIVOT-PO was designed in collaboration with GSK to provide tebipenem HBr with a clinical path to becoming the first oral carbapenem antibiotic for treatment of cUTI, if approved,” said Dr. Kamal Hamed, Chief Medical Officer of Spero.
  • “With increasing prevalence of antibiotic-resistant bacteria, cUTI patients often have no choice but to receive an intravenous (IV) carbapenem antibiotic in a hospital setting.
  • The goal of our tebipenem HBr program is to provide appropriate patients with an efficacious oral option for the treatment of cUTI.
  • We believe that tebipenem HBr has the potential to deliver strong value to the healthcare system.”
    PIVOT-PO is a global, randomized, double-blind, pivotal Phase 3 clinical trial of oral tebipenem HBr vs. IV imipenem cilastatin, in hospitalized adult patients with cUTI/AP.

Iterum Therapeutics Reports First Quarter 2023 Financial Results

Retrieved on: 
Friday, May 12, 2023
Prejudice, Ertapenem, IV, UTI, Infection, NDA, Cutis verticis gyrata, Urinary tract infection, Woman, G&A, Renewable Energy and Energy Efficiency Partnership, Clinical trial, ECCMID, Patient, Investment, ITRM, SPA, R, Ciprofloxacin, Research, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, DOOR, Food, Pharmaceutical industry

DUBLIN, Ireland and CHICAGO, May 12, 2023 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported financial results for the first quarter ended March 31, 2023.

Key Points: 
  • DUBLIN, Ireland and CHICAGO, May 12, 2023 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported financial results for the first quarter ended March 31, 2023.
  • Research and development (R&D) expenses for the first quarter 2023 were $6.4 million, compared to $3.4 million for the same period in 2022.
  • General and administrative (G&A) expenses for the first quarter 2023 were $2.1 million, compared to $3.9 million for the same period in 2022.
  • Non-GAAP1 net loss for the first quarter 2023 of $7.4 million, compared to a non-GAAP1 net loss of $5.6 million for the same period in 2022.

Iterum Therapeutics Presents Scientific Posters at ECCMID 2023 Highlighting Application of Desirability of Outcomes Ranking (DOOR) to two Registration Trials

Retrieved on: 
Thursday, April 20, 2023
Ertapenem, IV, Infection, Cutis verticis gyrata, Congress, ECCMID, Patient, European, ITRM, Ciprofloxacin, Therapy, Poster, DOOR, Pharmaceutical industry

The posters presented at ECCMID were:

Key Points: 
  • The posters presented at ECCMID were:
    The desirability of outcome ranking (DOOR), not yet accepted by regulatory authorities as a primary endpoint for urinary tract infection studies, is a novel method of analyzing data from clinical trials taking into account both benefits and harms of drugs being evaluated and providing an assessment of the patient experience.
  • It was utilized recently by the Antibacterial Resistance Leadership Group (ARLG) to develop a method to evaluate data from completed pivotal cUTI trials.
  • “Applying the ARLGs approach retrospectively to our two Phase 3 studies of sulopenem, one each in cUTI and uUTI, respectively, demonstrated that oral sulopenem was comparably more effective than ciprofloxacin in patients with uUTI and provided comparable efficacy to ertapenem in patients with cUTI,” said Dr. Sailaja Puttagunta, Chief Medical Officer of Iterum Therapeutics.
  • These Posters are available on the Company’s website on the “Publications: Posters & Presentations” page under the “Our Science” tab.

Spero Therapeutics to Present at the 5th Annual Evercore ISI HealthCONx Conference

Retrieved on: 
Tuesday, November 22, 2022
GSK, Infection, Degenerative disease, Conference, Bacteria, Therapy, Patient, Cutis verticis gyrata, HBR, Pyelonephritis, Research, MDR, FDA, Tebipenem, Pharmaceutical industry, Spero

A replay of the fireside chat will be available on the website following the conclusion of the event.

Key Points: 
  • A replay of the fireside chat will be available on the website following the conclusion of the event.
  • Spero Therapeutics, headquartered in Cambridge, Massachusetts,is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing, and commercializing novel treatments for bacterial infections, including multi-drug resistant bacterial infections and rare diseases.
  • Spero Therapeuticsis developing SPR720 as a novel oral therapy candidate for the treatment of a rare, orphan pulmonary disease caused by non-tuberculous mycobacterial infections.
  • However, while Spero may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.

Spero Therapeutics Announces Closing of Exclusive License Agreement with GSK for Tebipenem HBr

Retrieved on: 
Tuesday, November 8, 2022
GLOBE, Adult, Cutis verticis gyrata, Infection, Pyelonephritis, Tebipenem, Nasdaq, MDR, Research, Therapy, U.S. Securities and Exchange Commission, No, GSK, HBR, Degenerative disease, Patient, Bacteria, Urinary tract infection, FDA, Limited, Pharmaceutical industry, Vaccine, Spero, Meiji Seika

3) Limited (LSE/NYSE: GSK) (GSK) for tebipenem HBr, an investigational drug being developed as the potentially first oral carbapenem antibiotic for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain bacteria.

Key Points: 
  • 3) Limited (LSE/NYSE: GSK) (GSK) for tebipenem HBr, an investigational drug being developed as the potentially first oral carbapenem antibiotic for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain bacteria.
  • In exchange, GSK has been granted an exclusive license to develop and commercialize tebipenem pivoxil and tebipenem pivoxil HBr in all territories, except Japan, and certain other Asian countries, territories which will be retained by Spero partner, Meiji Seika.
  • Under the terms of the license agreement, Spero is responsible for the execution and costs of a follow-up Phase 3 clinical trial of tebipenem HBr.
  • GSK is responsible for the execution and costs of additional development, including Phase 3 regulatory filing and commercialization activities for tebipenem HBr outside of the Meiji Seika territory.

Spero Therapeutics to Provide Business Update and Report Third Quarter 2022 Financial Results on Monday, November 14, 2022

Retrieved on: 
Monday, November 7, 2022
Cutis verticis gyrata, Company, HBR, MDR, GLOBE, FDA, Adult, Infection, Therapy, Nasdaq, Pyelonephritis, Bacteria, Degenerative disease, ID, Spero, Patient, Tebipenem, Pharmaceutical industry

ET to report its third quarter 2022 financial results and provide an update on its business and pipeline.

Key Points: 
  • ET to report its third quarter 2022 financial results and provide an update on its business and pipeline.
  • To access the call, please dial 1-855-327-6837 (domestic) or 1-631-891-4304 (international) and refer to conference ID 10020538.
  • The audio webcast can be accessed under "Events and Presentations" in the Investor and Media section of the Company's website at www.sperotherapeutics.com .
  • Spero Therapeuticsis developing SPR720 as a novel oral therapy candidate for the treatment of a rare, orphan pulmonary disease caused by non-tuberculous mycobacterial infections.

Spero Therapeutics to Host Virtual R&D Event on Non-Tuberculous Mycobacterial Pulmonary Disease and the SPR720 Program

Retrieved on: 
Monday, October 3, 2022
Area studies, Ponce Health Sciences University, Degenerative disease, Tuberculosis, Science, U.S. Securities and Exchange Commission, Adult, Physician, Center for Epidemiologic Studies Depression Scale, Nasdaq, Research, Infection, Pyelonephritis, NTM, Rheumatology, Mentorship, FDA, MPH, HBR, MDR, Tebipenem, Q&A, Public health, Oregon Health and Science University Center for Women's Health, Bacteria, Therapy, Cutis verticis gyrata, Oregon Health & Science University, Bronchiectasis, OHSU, Patient, Division, Center, Publication, Universal Music Publishing Group, GLOBE, Ophthalmology, Pharmaceutical industry, Spero, MD

CAMBRIDGE, Mass., Oct. 03, 2022 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying, developing and commercializing treatments in high unmet need areas involving rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that it will host a virtual R&D event on Thursday, October 6, 2022, at 11:30 a.m. Eastern Time.

Key Points: 
  • The virtual event will feature a presentation by key opinion leader, Kevin L. Winthrop, MD, MPH, from the Division of Infectious Disease, OHSU Medical School.
  • During his presentation, Dr. Winthrop will discuss the etiology, unmet medical need, and treatment landscape of non-tuberculous mycobacteria (NTM) pulmonary disease.
  • Members of the Spero management team will provide an overview of the development program for SPR720, a potential novel first line oral therapy for NTM infections.
  • Spero Therapeuticsis developing SPR720 as a novel oral therapy candidate for the treatment of a rare, orphan pulmonary disease caused by non-tuberculous mycobacterial infections.

Spero Therapeutics Announces Appointment of Kamal Hamed, MD, MPH, MBA, as Chief Medical Officer

Retrieved on: 
Thursday, September 15, 2022
Adult, American University, MPH, American University of Beirut, Roivant Sciences, Time, Joint Medical Service (Germany), American College, COVID-19, Infection, Risk, FDA, Urinary tract infection, U.S. Securities and Exchange Commission, Basilea Pharmaceutica, Degenerative disease, Partnership, CMO, Therapy, Medical Affairs Bureau, Program, Patient, University, MBA, Bristol Myers Squibb, Physician, American College of Physicians, Tebipenem, Nasdaq, Stanford University School of Medicine, Novartis, Internal medicine, Johns Hopkins University, Pyelonephritis, Research, GLOBE, HBR, Cutis verticis gyrata, Infectious Diseases Society of America, Robert Wood Johnson Medical School, Pharmaceutical industry, MD, Bayer, Aleksei Lysov, Spero

CAMBRIDGE, Mass., Sept. 15, 2022 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc.(Nasdaq: SPRO) today announced the appointment of Kamal Hamed, MD, MPH, MBA, as Chief Medical Officer (CMO).

Key Points: 
  • CAMBRIDGE, Mass., Sept. 15, 2022 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc.(Nasdaq: SPRO) today announced the appointment of Kamal Hamed, MD, MPH, MBA, as Chief Medical Officer (CMO).
  • Kamal joins Spero with an impressive track record of building and leading successful anti-infective franchises, said Ankit Mahadevia, MD, Chief Executive Officer of Spero Therapeutics.
  • I am thrilled to have Kamal on our management team and look forward to working together.
  • Dr. Hamed has over 20 years of experience leading various anti-infective clinical development programs in antibacterials, antivirals, antimalarials, and antifungals.

Spero Therapeutics to Present at Upcoming Investor Conference

Retrieved on: 
Wednesday, September 7, 2022
Spero, Degenerative disease, Therapy, HBR, Infection, Tebipenem, Cutis verticis gyrata, GLOBE, Conference, Nasdaq, FDA, Pyelonephritis, Adult, MDR, Patient, Pharmaceutical industry

Webcasts of the presentations may also be accessed through Spero Therapeutics website ( www.sperotherapeutics.com ) on the Events and Presentations page under the Investors and Media tab.

Key Points: 
  • Webcasts of the presentations may also be accessed through Spero Therapeutics website ( www.sperotherapeutics.com ) on the Events and Presentations page under the Investors and Media tab.
  • Spero Therapeuticsis a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing, and commercializing novel treatments for bacterial infections, including multi-drug resistant bacterial infections and rare diseases.
  • Spero Therapeuticsis developing SPR720 as a novel oral therapy candidate for the treatment of a rare, orphan pulmonary disease caused by non-tuberculous mycobacterial infections.
  • Spero Therapeutics also has an IV-administered next generation polymyxin product candidate, SPR206, developed from its potentiator platform, which is in development to treat multi-drug resistant Gram-negative infections in the hospital setting.