Staphylococcus

Azitra, Inc. Announces Positive Preclinical Data from ATR-04 Presented at the Society of Investigative Dermatology Annual Meeting

Retrieved on: 
fredag, maj 17, 2024

Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced preclinical data from the Company’s platform and pipeline.

Key Points: 
  • Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced preclinical data from the Company’s platform and pipeline.
  • “We are pleased to announce the first publication of preclinical data around ATR-04 in EGFR inhibitor (EGFRi)-associated dermal toxicity,” said Travis Whitfill, Azitra’s co-founder and COO.
  • The data in the oral presentations today showcase the preclinical development of ATR-04.
  • Together, the data show that ATR-04 can address multiple drivers of EGFRi-induced skin toxicity.

Basilea reports presentation of new data for ceftobiprole (Zevtera®) at ESCMID Global 2024

Retrieved on: 
fredag, maj 3, 2024

Data presented on a third poster demonstrated that bloodstream clearance was achieved at a median of four days after the start of treatment in both the ceftobiprole and comparator groups.

Key Points: 
  • Data presented on a third poster demonstrated that bloodstream clearance was achieved at a median of four days after the start of treatment in both the ceftobiprole and comparator groups.
  • In the group treated with ceftobiprole, fewer patients had Staphylococcus aureus-positive blood cultures after ten days compared to the comparator treatment group.
  • An oral presentation focused on a re-analysis of the previously conducted ceftobiprole phase 3 study in patients with community-acquired bacterial pneumonia (CABP).
  • Using the FDA-CABP-2020 primary endpoint of early clinical success at day 3 after study start, this re-analysis supported the non-inferiority of ceftobiprole to ceftriaxone ± linezolid.

Concert Announces Clinical Advisory Board, New Medical Policies

Retrieved on: 
onsdag, maj 1, 2024

NASHVILLE, Tenn., May 1, 2024 /PRNewswire/ -- As part of its commitment to provide transparent, evidence-based medical policy and enable accurate reimbursement for a broader set of diagnostic services, Concert today announced the establishment of an advisory board of experts in clinical laboratory medicine and the release of policies for an expanded scope of routine and advanced laboratory testing.

Key Points: 
  • The newly formed board will advise Concert on its clinical laboratory content.
  • "Concert is working to align payers, providers, and labs to enable patient access to evidence-based testing," said Dr. Girish Putcha.
  • Following are brief bios on each member of the new clinical advisory board, in alphabetical order by last name.
  • Recent roles include Director of Laboratory Science at Palmetto's MolDX program, Chief Medical Officer and Clinical Laboratory Director of Freenome, and Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) member.

Azitra, Inc. to Present New Data at Three Upcoming Scientific Conferences in May 2024

Retrieved on: 
torsdag, april 18, 2024

Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced it will be presenting promising new preclinical data from its platform built (or optimized) to discover treatments for serious skin diseases at three upcoming scientific and medical conferences:

Key Points: 
  • Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced it will be presenting promising new preclinical data from its platform built (or optimized) to discover treatments for serious skin diseases at three upcoming scientific and medical conferences:
    Title: Preclinical development of ATR04-484, an auxotrophic strain of Staphylococcus epidermidis, for the topical treatment of epidermal growth factor receptor (EGFR) inhibitor-induced dermal toxicity

FDA Approves New Treatment for Uncomplicated Urinary Tract Infections

Retrieved on: 
onsdag, april 24, 2024

SILVER SPRING, Md., April 24, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.

Key Points: 
  • SILVER SPRING, Md., April 24, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.
  • "The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Pivya will provide an additional treatment option for uncomplicated UTIs."
  • Uncomplicated UTIs are bacterial infections of the bladder in females with no structural abnormalities of their urinary tract.
  • Approximately one-half of all women experience at least one UTI in their lifetime.

Chemical pollutants can change your skin bacteria and increase your eczema risk − new research explores how

Retrieved on: 
tisdag, april 23, 2024

Also known as atopic dermatitis, this chronic skin disease affects about 1 in 5 children in the industrialized world.

Key Points: 
  • Also known as atopic dermatitis, this chronic skin disease affects about 1 in 5 children in the industrialized world.
  • Some studies have found rates of eczema in developing nations to be over thirtyfold lower compared with industrialized nations.
  • Scientists know that factors such as diets rich in processed foods as well as exposure to specific detergents and chemicals increase the risk of developing eczema.
  • Living near factories, major roadways or wildfires increase the risk of developing eczema.

There’s something in the air

  • Then we looked at databases from the U.S. Environmental Protection Agency to see which chemicals were most common in those areas.
  • Diisocyanates were first manufactured in the U.S. around 1970 for the production of spandex, nonlatex foam, paint and polyurethane.
  • The manufacture of xylene also increased around that time, alongside an increase in the production of polyester and other materials.
  • After 1975, when all new cars became outfitted with a new technology that converted exhaust gas to less toxic chemicals, isocyanate and xylene both became components of automobile exhaust.
  • How directly exposing mice to these toxins compares to the typical levels of exposure in people is still unclear.

Skin microbiome and pollution

  • Every person is coated with millions of microorganisms that live on the skin, collectively referred to as the skin microbiome.
  • You’ve probably seen moisturizers and other skin products containing ceramides, a group of lipids that play an important role in protecting the skin.
  • To see which toxins could prevent production of the beneficial lipids that prevent eczema, my team and I used skin bacteria as canaries in the coal mine.
  • Lysine helps protect the bacteria from the harms of the toxins but doesn’t provide the health benefits of ceramides.
  • Bacteria that help keep skin healthy could live on any fabric, but, just as with air pollution, the amount of beneficial lipids they made dropped to less than half the levels made when grown on fabrics like cotton.

Addressing pollution’s effects on skin

  • Detectors capable of sensing low levels of isocyanate or xylene could help track pollutants and predict eczema flare-ups across a community.
  • Better detectors can also help researchers identify air filtration systems that can scrub these chemicals from the environment.
  • In the meantime, improving your microbial balance may require avoiding products that limit the growth of healthy skin bacteria.
  • I believe that it may one day allow us to get back to a time when these diseases were uncommon.


Ian Myles receives funding from the Department of Intramural Research at the National Institute of Allergy and Infectious Diseases. He is the author of, and receives royalties for, the book GATTACA Has Fallen: How population genetics failed the populace. Although he is the co-discoverer of Roseomonas mucosa RSM2015 for eczema, he has donated the patent to the public and has no current conflict of interest for its sales.

Recce Pharmaceuticals Granted New Patent in Israel for RECCE® Anti-Infectives

Retrieved on: 
torsdag, april 4, 2024

SYDNEY, Australia, April 04, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q), the Company developing a new class of synthetic anti-infectives, today announced that the State of Israel Patent Office has formally granted Recce a new family four patent (patent number: 295116), “Process for Preparation of Biologically Active Copolymer Comprising an Acrolein Derivative and a Polyalkylene Glycol Oligomer,” with expiry in 2041.

Key Points: 
  • SYDNEY, Australia, April 04, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q), the Company developing a new class of synthetic anti-infectives, today announced that the State of Israel Patent Office has formally granted Recce a new family four patent (patent number: 295116), “Process for Preparation of Biologically Active Copolymer Comprising an Acrolein Derivative and a Polyalkylene Glycol Oligomer,” with expiry in 2041.
  • “We are thrilled to have received this newly granted patent in Israel,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals.
  • Israel’s pharmaceuticals and biotechnology market has a reputation for high R&D spending and an impressive international reach, with world-class export numbers and a growing market value.
  • Other examples include influenza A, Ross River virus, and coronaviruses, including those responsible for severe acute respiratory syndrome and SARS-CoV-2 (COVID-19).

Basilea announces US FDA approval of antibiotic ZEVTERA® (ceftobiprole medocaril) for three indications

Retrieved on: 
torsdag, april 4, 2024

David Veitch, Chief Executive Officer of Basilea, said: “We are excited with the US approval of ZEVTERA.

Key Points: 
  • David Veitch, Chief Executive Officer of Basilea, said: “We are excited with the US approval of ZEVTERA.
  • The positive decision by the FDA is a key milestone towards bringing ZEVTERA to patients in the US.
  • This approval is a landmark for ceftobiprole and reflects its broad clinical utility.
  • Through this partnership, Basilea has been awarded approximately USD 112 million, or approximately 75 percent of the costs related to the SAB and ABSSSI phase 3 studies, regulatory activities and non-clinical work.

Evaxion and Undisclosed Collaborator Announce Encouraging Results for EVX-B1 Vaccine Antigens Against Staphylococcus Aureus Infection

Retrieved on: 
tisdag, april 2, 2024

In the animal studies, the EVX-B1 antigens significantly reduced disease burden.

Key Points: 
  • In the animal studies, the EVX-B1 antigens significantly reduced disease burden.
  • Birgitte Rønø, Chief Scientific Officer at Evaxion, expresses enthusiasm: “We are very thrilled about the encouraging data and believe that our EVX-B1 vaccine antigens hold the potential for efficacy in human trials – a milestone that previous vaccine attempts have failed to achieve.”
    There is no S. aureus vaccine available for human use.
  • Also, the presence of antibiotic-resistant S. aureus is limiting available treatment options.
  • The Centers for Disease Control and Prevention (CDC) has reported 120,000 bloodstream infections associated with S. aureus in the US annually.

BiomX Announces Entry into Merger Agreement with Adaptive Phage Therapeutics and Concurrent $50 Million Financing

Retrieved on: 
onsdag, mars 6, 2024

CAMBRIDGE, Mass. and NESS ZIONA, Israel, March 06, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (together with its subsidiaries and/or associates, “BiomX”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced that it has entered into a definitive merger agreement with Adaptive Phage Therapeutics, Inc. (“APT”), a U.S.-based privately-held, clinical-stage biotechnology company pioneering the development of phage-based therapies to combat bacterial infections (the “Acquisition”). Immediately after the effective time of the Acquisition, and before giving effect to the concurrent private placement the former stockholders of BiomX will own approximately 55% and the former stockholders of APT will own approximately 45% of the consolidated entity of BiomX and APT. The Acquisition is expected to close within the next 30 days, subject to the satisfaction of the closing conditions described in the definitive merger agreement. Concurrently with entering into the definitive merger agreement, BiomX entered into a definitive purchase agreement for the sale of shares of newly created non-voting convertible preferred stock (“Series X Preferred Stock”) and warrants to purchase shares of BiomX common stock in a private placement to certain institutional accredited investors led by affiliates of Deerfield Management Company and the AMR Action Fund, and additional investors including the Cystic Fibrosis Foundation, OrbiMed and Nantahala Capital. The private placement is expected to result in gross proceeds to BiomX of $50 million before deducting placement agent and other offering expenses. The proceeds from the private placement are expected to provide funding through the results from a planned Phase 2b trial that will evaluate BiomX’s lead product candidate, BX004, for the treatment of chronic pulmonary infections caused by Pseudomonas aeruginosa (P. aeruginosa) in CF patients expected in the third quarter of 2025 and Phase 2 results from APT’s clinical-stage product candidate, now named BX211, for the treatment of Staphylococcus aureus (S. aureus) infections in DFO patients expected in the first quarter of 2025. The private placement is expected to close substantially concurrently with, and subject to the closing of, the Acquisition.

Key Points: 
  • Immediately after the effective time of the Acquisition, and before giving effect to the concurrent private placement the former stockholders of BiomX will own approximately 55% and the former stockholders of APT will own approximately 45% of the consolidated entity of BiomX and APT.
  • The Acquisition is expected to close within the next 30 days, subject to the satisfaction of the closing conditions described in the definitive merger agreement.
  • The private placement is expected to result in gross proceeds to BiomX of $50 million before deducting placement agent and other offering expenses.
  • The private placement is expected to close substantially concurrently with, and subject to the closing of, the Acquisition.