Antimicrobial Agents and Chemotherapy

Ascletis Announces U.S. FDA Approval of Conducting a Phase IIa Clinical Trial for ASC10 to Treat Respiratory Syncytial Virus Infection

Retrieved on: 
Tuesday, January 31, 2023
Safety, Antimicrobial Agents and Chemotherapy, Phase, Death, Tablet, Monkeypox virus, Inflammation, SARS-CoV-2, Viral, Infection, Pharmacokinetics, Patent, NHC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, RSV, FDA, Bronchiolitis, Pneumonia, Patient, Respiratory syncytial virus, Food, Lung, Respiratory syncytial virus vaccine, EC50, HKEX, Medical device, Pharmaceutical industry, Vaccine

HANGZHOU and SHAOXING, China, Jan. 31, 2023 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that the U.S. Food and Drug Administration ("FDA") has approved to conduct a Phase IIa clinical trial for ASC10 to treat respiratory syncytial virus (RSV) infection. Based on available data, dosage of 800 mg ASC10, twice daily was selected to conduct a randomized, double-blind, placebo-controlled Phase IIa study to evaluate the antiviral activity, safety, tolerability and pharmacokinetics of ASC10 tablets in patients with mild or moderate RSV infection.

Key Points: 
  • --Dosage of 800 mg ASC10, twice daily was selected to conduct a Phase IIa study in patients with RSV infection
    HANGZHOU and SHAOXING, China, Jan. 31, 2023 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that the U.S. Food and Drug Administration ("FDA") has approved to conduct a Phase IIa clinical trial for ASC10 to treat respiratory syncytial virus (RSV) infection.
  • After oral administration, ASC10 is rapidly and completely converted in vivo into the active metabolite ASC10-A, also known as β -D-N4-hydroxycytidine (NHC) or EIDD-1931.
  • Ascletis has been granted a patent of ASC10 and its derivatives, and their uses to treat multiple virus infections by the United States Patent and Trademark Office (USPTO), including SARS-CoV-2, monkeypox virus and RSV.
  • We are glad that ASC10 has obtained the U.S. FDA approval to conduct a Phase IIa study to treat RSV infection in patients, which is a new milestone of Ascletis' R&D in treatment for viral diseases.

ContraFect Announces Multiple Publications Highlighting the Potential Utility of Lysins for the Treatment of Bone and Joint Infections

Retrieved on: 
Monday, September 12, 2022
Pseudomonas aeruginosa, Daptomycin, Infection, Staphylococcus epidermidis, Journal, FDA, Staphylococcus, Editorial, Publication, Maintenance, Lysin, U.S. Securities and Exchange Commission, Forward-looking statement, Patient, Clinical trial, Breakthrough therapy, SOC, Pneumonia, Bji Gewog, Cons, Nasdaq, DLA, MRSA, Bacteria, Osteomyelitis, Death, Endocarditis, Vancomycin, Security (finance), GLOBE, Antimicrobial Agents and Chemotherapy, State, Campaign, Biofilm, Peptide, Subclinical infection, Enterobacter, Acinetobacter baumannii, Pharmaceutical industry

The authors conclude that these advantages could compensate for the treatment challenges with current antibiotic treatments against staphylococcal BJIs alone.

Key Points: 
  • The authors conclude that these advantages could compensate for the treatment challenges with current antibiotic treatments against staphylococcal BJIs alone.
  • Exebacase displayed significant anti-biomass and bactericidal activity against S. epidermidis biofilms, as well as synergistic effects in addition to rifampicin, vancomycin, and daptomycin.
  • Prosthetic joint infections are particularly problematic, often requiring joint removal and reimplantation.
  • ContraFect is a biotechnology company focused on the discovery and development of DLAs, including lysins and amurin peptides, as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections.

Micreos Pharmaceuticals announces success of its XZ.700 technology in selectively eliminating Staphylococcus aureus pathogen without triggering resistance

Retrieved on: 
Thursday, April 14, 2022
Drug development, AMR, Staphylococcus, S. aureus, Micreos, ETH, Staphylococcus epidermidis, Research, Element, Bacteria, Infection, Drug discovery, Doctor of Philosophy, Patient, Technology, Death, Skin, Swiss Federal Institute of Aquatic Science and Technology, Swiss, ETH Zurich, Antimicrobial Agents and Chemotherapy, Staphylococcus aureus, Swiss Federal Institute of Technology, Pharmaceutical industry

ZUG, Switzerland, April 14, 2022 /PRNewswire/ -- Micreos Pharmaceuticals today announces findings from a study proving the effectiveness of XZ.700, a novel antibacterial enzyme, in selectively targeting and killing the harmful Staphylococcus aureus bacterial pathogen while maintaining a healthy microbiome and preventing antimicrobial resistance (AMR). XZ.700 is the first of many innovative endolysins in the Micreos Pharmaceuticals portfolio and is critically important as the first molecule the company will bring to market. The findings were published in Antimicrobial Agents and Chemotherapy.

Key Points: 
  • S. aureusis a pathogen associated with causing and aggravating a wide spectrum of conditions, ranging from mild disorders to life-threatening disease.
  • Theseinfections can be difficult to treat because S. aureus can hide in niches within the body, and it readily develops resistance to antibiotics.
  • "With our technology, we have the possibility to selectively target the pathogen S. aureus while preserving a healthy skin microbiome.
  • Its proprietary endolysin technology has been created together with the Swiss Federal Institute of Technology, ETH in Zurich.

Micreos Pharmaceuticals announces success of its XZ.700 technology in selectively eliminating Staphylococcus aureus pathogen without triggering resistance

Retrieved on: 
Thursday, April 14, 2022
Drug development, AMR, Staphylococcus, S. aureus, Micreos, ETH, Staphylococcus epidermidis, Research, Element, Bacteria, Infection, Drug discovery, Doctor of Philosophy, Patient, Technology, Death, Skin, Swiss Federal Institute of Aquatic Science and Technology, Swiss, ETH Zurich, Antimicrobial Agents and Chemotherapy, Staphylococcus aureus, Swiss Federal Institute of Technology, Pharmaceutical industry

ZUG, Switzerland, April 14, 2022 /PRNewswire/ -- Micreos Pharmaceuticals today announces findings from a study proving the effectiveness of XZ.700, a novel antibacterial enzyme, in selectively targeting and killing the harmful Staphylococcus aureus bacterial pathogen while maintaining a healthy microbiome and preventing antimicrobial resistance (AMR). XZ.700 is the first of many innovative endolysins in the Micreos Pharmaceuticals portfolio and is critically important as the first molecule the company will bring to market. The findings were published in Antimicrobial Agents and Chemotherapy.

Key Points: 
  • S. aureusis a pathogen associated with causing and aggravating a wide spectrum of conditions, ranging from mild disorders to life-threatening disease.
  • Theseinfections can be difficult to treat because S. aureus can hide in niches within the body, and it readily develops resistance to antibiotics.
  • "With our technology, we have the possibility to selectively target the pathogen S. aureus while preserving a healthy skin microbiome.
  • Its proprietary endolysin technology has been created together with the Swiss Federal Institute of Technology, ETH in Zurich.

Entasis Therapeutics Announces Year End 2021 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 3, 2022
Failure, Yersinia pestis, Nature, Population, U.S. Securities and Exchange Commission, Director, Nephrotoxicity, Board, Acquisition, Cooperative, Nasdaq, Wellcome Trust, Private Securities Litigation Reform Act, NIH, Forward-looking statement, Public relations, Acinetobacter, News, QT, Company, Antimicrobial Agents and Chemotherapy, Revlon, Inc. v. MacAndrews & Forbes Holdings, Inc., Clinical trial, Colistin, Pseudomonas aeruginosa, Research, Infection, National Rural Development Partnership, Letter, Ceftriaxone, Burkholderia pseudomallei, NDA, Covington & Burling, Gram, Patient, Safety, Gonorrhea, Test, Schedule, Mortality, Insurance, Schedule 13D, GLOBE, Pharmaceutical industry, Risk management, Vaccine, Entasis, Pseudomonas

The incredible effort and commitment of our employees and partners in 2021 has resulted in a very productive year for Entasis, said Manos Perros, Chief Executive Officer at Entasis.

Key Points: 
  • The incredible effort and commitment of our employees and partners in 2021 has resulted in a very productive year for Entasis, said Manos Perros, Chief Executive Officer at Entasis.
  • Mortality analyses in all pre-specified populations included in the topline results unequivocally favored SUL-DUR versus colistin.
  • General and administrative expenses were $15.2million for theyear ended December31, 2021, compared to $13.2million for theyear ended December31, 2020.
  • As of December 31, 2021, we had cash and cash equivalents of $32.3 million, compared to $53.2 million as of December 31, 2020.

Atea Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update

Retrieved on: 
Monday, February 28, 2022
PLOS Neglected Tropical Diseases, HIV disease progression rates, Fever Dream, Conference call, RNA, Niran, COVID-19, Company, Sofosbuvir, Dengue fever, Severe acute respiratory syndrome coronavirus 2, Atea, RZR, Viremia, Nasdaq, Nature Communications, Survival, Research, Development, NS5A, Dengue virus, Viral load, Income tax, Safety, SOF, Founder, Patient, Yellow, Clinical trial, RNA polymerase II, Program, Cash, Doctor of Philosophy, HCV, PLOS, Administration, Lists of academic journals, Vital signs, Preclinical development, Alpha, BID, Protease, State Administrative Expenses, GLOBE, Income, IV, Adult, Antimicrobial Agents and Chemotherapy, Conference, PK, Infection, Time, Pharmaceutical industry, Medical device, Vaccine, Pharmacokinetics, Merck, Pharmacodynamics

BOSTON, Feb. 28, 2022 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today reported financial results for the fourth quarter and full year ended December 31, 2021 and provided a business update.   

Key Points: 
  • ET today
    BOSTON, Feb. 28, 2022 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea), a clinical-stage biopharmaceutical company, today reported financial results for the fourth quarter and full year ended December 31, 2021 and provided a business update.
  • Importantly, we have the financial strength and a seasoned management team to advance these programs through key clinical and regulatory inflection points, concluded Dr. Sommadossi.
  • Bemnifosbuvir Development Summary: In 2021, Atea reported data from two monotherapy Phase 2 clinical trials evaluating bemnifosbuvir for the treatment of COVID-19.
  • In addition, the Company recorded a $25.0 million expense during the fourth quarter 2021 due to an upfront payment related to the in-license of ruzasvir from Merck.

Allecra Therapeutics and ADVANZ PHARMA Sign Exclusive License and Supply Agreement for Allecra’s Antibiotic Cefepime/enmetazobactam in Europe

Retrieved on: 
Thursday, January 13, 2022
Biotechnology, Other Health, Health, Pharmaceutical, Clinical Trials, Technical, CDC, Esbly, Patient, Pneumonia, Urinary tract infection, Cephalosporin, LinkedIn, EMA, Union, Regulation of tobacco by the U.S. Food and Drug Administration, Cutis, European Medicines Agency, Safety, Piperacillin/tazobactam, Investor, Human services, Cefepime, Standard of care, Review, GA, Marketing, Therapy, Penicillin, Company, Abstract (summary), Multimedia, Cephamycin, Risk, Food, Complicated, FDA, Lists of countries and territories, Antimicrobial Agents and Chemotherapy, United Kingdom, United States Department of Health and Human Services, Fine chemical, Pharmaceutical industry, Antibiotics, EU, cefepime/enmetazobactam, Allecra Therapeutics, ADVANZ PHARMA, CEFEPIME/ENMETAZOBACTAM, ALLECRA THERAPEUTICS, ADVANZ PHARMA

ADVANZ PHARMA Corp. Limited ("ADVANZ PHARMA"), a specialty pharmaceutical company with a strategic focus on hospital medicines in Europe, and Allecra Therapeutics (Allecra) today announced that the companies have signed an exclusive license agreement under which ADVANZ PHARMA gains the rights to develop and commercialize Allecras antibiotic drug candidate cefepime/enmetazobactam within the European Union, the United Kingdom, Switzerland, and Norway.

Key Points: 
  • ADVANZ PHARMA Corp. Limited ("ADVANZ PHARMA"), a specialty pharmaceutical company with a strategic focus on hospital medicines in Europe, and Allecra Therapeutics (Allecra) today announced that the companies have signed an exclusive license agreement under which ADVANZ PHARMA gains the rights to develop and commercialize Allecras antibiotic drug candidate cefepime/enmetazobactam within the European Union, the United Kingdom, Switzerland, and Norway.
  • In exchange for the exclusive license, Allecra will receive an upfront payment and development and sales milestones for cefepime/enmetazobactam, as well as double-digit tiered royalties.
  • In addition, the two companies have signed a supply agreement under which Allecra will supply the cefepime/enmetazobactam finished product in the agreed upon territories.
  • Allecra Therapeutics, founded in 2013, is a private, clinical-stage biopharmaceutical company developing novel therapies to combat antibiotic resistance by overcoming emergent resistance mechanisms.

Peptilogics Announces FDA Clearance of Investigational New Drug Application to Initiate Clinical Trial of PLG0206 in Periprosthetic Joint Infection

Retrieved on: 
Monday, January 10, 2022
Biotechnology, Pharmaceutical, Surgery, Health, FDA, Infectious Diseases, Clinical Trials, Other Health, Antimicrobial Agents and Chemotherapy, Safety, Biofilm, Algorithm, Bacteria, LinkedIn, Failure, Death, Pharmacokinetics, Infection, Patient, World Health Organization, IND, ID, Debridement, Center, World, Phenotype, Food, Research, Cooperative, Artificial intelligence, Technology, Founders Fund, FDA, Centers for Disease Control and Prevention timeline, Therapy, QIDP, Twitter, TKA, Ageing, Trust law, Wellcome Trust, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pharmaceutical industry, Microbiology Spectrum, Periprosthetic Joint Infection (PJI), Peptilogics, PERIPROSTHETIC JOINT INFECTION (PJI), PEPTILOGICS

PLG0206 is an investigational broad-spectrum, anti-biofilm, anti-infective peptide therapeutic.

Key Points: 
  • PLG0206 is an investigational broad-spectrum, anti-biofilm, anti-infective peptide therapeutic.
  • PLG0206 has previously been granted FDA Orphan Drug Designation for the treatment of PJI and has been designated as a Qualified Infectious Disease Product (QIDP) as well.
  • In December, Peptilogics announced the publication of two peer-reviewed studies on PLG0206.
  • Peptilogics is backed by visionary investors in life science and technology including Peter Thiel, Presight Capital, CARB-X, and Founders Fund.

Peptilogics Announces Two Peer-Reviewed Publications on Designed Peptide Therapeutic PLG0206 for Periprosthetic Joint Infection

Retrieved on: 
Wednesday, December 1, 2021
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Patient, Algorithm, Pharmacokinetics, Peptide, Half-life, Biofilm, Paper, Technology, Bacteria, Cooperative, MD, Antimicrobial Agents and Chemotherapy, Doctor of Philosophy, Tolerability, Peter Thiel, Therapy, Trust law, AAC, Twitter, Research, Clinician Administered PTSD Scale, Incidence, Knee, Infection, Artificial intelligence, KNEA, Wellcome Trust, Founders Fund, Person, LinkedIn, Single, Pharmaceutical industry, Antibiotics

The incidence of treatment emergent adverse events (TEAE) related to PLG0206 was low and most events were mild in severity and similar between the PLG0206 treatment and placebo groups.

Key Points: 
  • The incidence of treatment emergent adverse events (TEAE) related to PLG0206 was low and most events were mild in severity and similar between the PLG0206 treatment and placebo groups.
  • The median terminal half-life ranged from 7.37 to 19.92 hours, which is significantly longer when compared to other unmodified linear peptides.
  • PLG0206 represents the untapped potential to design peptides with enhanced therapeutic characteristics, enabling medicines to become simultaneously more effective and less toxic.
  • Using proprietary peptide engineering techniques, Peptilogics has optimized PLG0206 for both safety and rapidly, bactericidal, broad-spectrum activity against biofilms that harbor and protect bacteria from most antibiotics.

Shionogi to Present In Vitro and Real-World Data at IDWeek 2021 Demonstrating Activity of FETCROJA® (cefiderocol) Against Gram-Negative Pathogens

Retrieved on: 
Wednesday, September 29, 2021
Health, Other Health, Other Science, Research, Science, Pharmaceutical, Biotechnology, Benchmark, Serratia marcescens, Mortality, CNS, Pyelonephritis, Infection, Antimicrobial, Research, Antibacterial activity, 2021 Essex County Council election, AMPC, Degenerative disease, Escherichia coli, Central nervous system disease, Urinary tract infection, Health, Collection, Intention, FDA, Patient, Gastroenterology, Bacteria, Marketing, Antimicrobial Agents and Chemotherapy, CEO, Canadian International Council, Medicine, Esbly, Pseudomonas aeruginosa, Pain, Serine, Cell membrane, International Journal of Antimicrobial Agents, Gram-negative bacteria, Klebsiella pneumoniae, Penicillin-binding proteins, Cutis laxa, Tillotson, Cell, Abstract (summary), Enzyme, Treatment, Pharmaceutical industry, Medical device, Vaccine, FETCROJA® (cefiderocol), Shionogi, FETCROJA® (CEFIDEROCOL), SHIONOGI

Shionogi & Co., Ltd. (hereafter Shionogi) today announces that 11 abstracts on FETCROJA (cefiderocol) will be shared at IDWeek.

Key Points: 
  • Shionogi & Co., Ltd. (hereafter Shionogi) today announces that 11 abstracts on FETCROJA (cefiderocol) will be shared at IDWeek.
  • Abstracts will be available in the IDWeek Interactive Program and include:
    Poster #1058: In Vitro and in Vivo Antibacterial Activity of Cefiderocol against Burkholderia spp.
  • Cefiderocol is a siderophore cephalosporin antibiotic with a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens by acting as a siderophore.
  • Shionogi has a strong heritage in the field of anti-infectives and has been developing antimicrobial therapies for more than 60 years.