Allergic bronchopulmonary aspergillosis

TFF Pharmaceuticals Inc. and Uniphar Durbin Ireland Ltd. Announce the Opening of an Expanded Access Program for Voriconazole Inhalation Powder (TFF VORI) for the Treatment of Pulmonary Aspergillosis and Other Voriconazole Responsive Fungal Pulmonary Infec

Retrieved on: 
Monday, July 31, 2023
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The Expanded Access Program covers pulmonary aspergillosis including invasive pulmonary aspergillosis, chronic pulmonary aspergillosis, allergic bronchopulmonary aspergillosis, aspergillus tracheobronchitis, and aspergillus bronchoanastomotic infections as well as other voriconazole responsive fungal pulmonary infections.

Key Points: 
  • The Expanded Access Program covers pulmonary aspergillosis including invasive pulmonary aspergillosis, chronic pulmonary aspergillosis, allergic bronchopulmonary aspergillosis, aspergillus tracheobronchitis, and aspergillus bronchoanastomotic infections as well as other voriconazole responsive fungal pulmonary infections.
  • Uniphar Durbin Ireland Limited has been appointed to implement TFF Pharmaceutical’s Expanded Access Program in the United States, Australia, United Kingdom, Canada, and within select countries in Europe.
  • “We are pleased to be working with Durbin to offer the Expanded Access Program for TFF VORI,” said Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals.
  • The EAP comes after positive clinical outcomes in two patients with pulmonary fungal infection treated with TFF VORI on a compassionate use basis.

Pulmatrix Supports World Asthma Day 2023

Retrieved on: 
Tuesday, May 2, 2023
Exercise, ABPA, Asthma, Wheeze, Clinical trial, Pollen, Cough, Allergic bronchopulmonary aspergillosis, Lung, Pulmonary fibrosis, Patient, Smoke, Itraconazole, Dust, Cystic fibrosis, Aspergillus fumigatus, United Kingdom, Conditional sentence, Pharmaceutical industry

LEXINGTON, Mass., May 2, 2023 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and central nervous system disease using its patented iSPERSE™ technology, today announced its support for World Asthma Day.

Key Points: 
  • LEXINGTON, Mass., May 2, 2023 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and central nervous system disease using its patented iSPERSE™ technology, today announced its support for World Asthma Day.
  • Margaret Wasilewski, M.D., Chief Medical Officer of Pulmatrix, commented, "World Asthma Day is an important time of recognition for the 250 million patients worldwide with this chronic disease.
  • We are proud to support this important day and grateful for the potential opportunity to positively impact the asthma patient community."
  • For more about Pulmatrix inhaled product candidates, including PUR1900 (an inhaled form of itraconazole being developed for allergic broncho-pulmonary aspergillosis in patients with asthma), please visit: https://www.pulmatrix.com/pipeline.html .

Pulmocide Raises $52 Million to Fund Additional Late-Stage Development of Opelconazole

Retrieved on: 
Tuesday, December 6, 2022
Incidence, Aspergillosis, Chronic pulmonary aspergillosis, Cystic fibrosis, IP Group, Lung, Allergic bronchopulmonary aspergillosis, Immunodeficiency, IPA, Pulmonology, Biotechnology, Cystic Fibrosis Foundation, Asthma, Mortality, Critical care, Chronic obstructive pulmonary disease, USD, Patient, United, Vivo, Oxygen toxicity, EUR, Azole, Disease, CHF, Risk, Partnership, Pictet, Pharmaceutical industry, Aspergillus, Pulmocide

Proceeds from the financing will be used to further fund clinical development, manufacturing scale-up, and preparation for potential commercialization of opelconazole.

Key Points: 
  • Proceeds from the financing will be used to further fund clinical development, manufacturing scale-up, and preparation for potential commercialization of opelconazole.
  • Opelconazole is a potent, novel triazole antifungal that has been specifically designed for use as an inhaled therapy against pulmonary aspergillosis.
  • The Company is also conducting a Phase 2b clinical trial using opelconazole as a monotherapy for prophylaxis against aspergillus infections in patients following lung transplant surgery.
  • Under the United Kingdom’s Special Needs provision, opelconazole was found to be generally well tolerated and demonstrated remarkable clinical responses.

Jeito Capital strengthens its support in Pulmocide with participation in $52 million financing

Retrieved on: 
Tuesday, December 6, 2022
Asthma, Private equity, Pulmonology, United, Triazole, Mortality, Cystic fibrosis, Incidence, Series, Aspergillosis, Do Meu Jeito, Oxygen toxicity, Chronic pulmonary aspergillosis, Doctor of Philosophy, Critical care, Cystic Fibrosis Foundation, MD, Azole, Chronic obstructive pulmonary disease, Disease, Immunodeficiency, IP Group, Lung, Allergic bronchopulmonary aspergillosis, Growth, IPA, Investment, Risk, Respiratory disease, Patient, Pharmaceutical industry, Pulmocide, Aspergillus

Jeito previously led an oversubscribed $92 million raise in Pulmocide, and has since provided continuous support to the Company in line with its unique investment strategy.

Key Points: 
  • Jeito previously led an oversubscribed $92 million raise in Pulmocide, and has since provided continuous support to the Company in line with its unique investment strategy.
  • Jeito’s further investment in Pulmocide demonstrates our commitment to support the most innovative biopharmaceutical companies and accelerate the development of much-needed treatments for patients.
  • Jeito Capital has €534 million under management and a rapidly growing portfolio of investments.
  • A late-stage clinical program has been initiated to support registration in patients who have failed prior therapy for IPA.

Pulmatrix Announces Expansion of Executive Leadership Team to Progress Clinical Pipeline

Retrieved on: 
Tuesday, March 1, 2022
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"We are proud to welcome Dr. Wasilewski to the Pulmatrix Executive Team," said Ted Raad, Chief Executive Officer of Pulmatrix.

Key Points: 
  • "We are proud to welcome Dr. Wasilewski to the Pulmatrix Executive Team," said Ted Raad, Chief Executive Officer of Pulmatrix.
  • Pulmatrix will immediately benefit from her leadership in the clinical strategy and delivery of the clinical trial milestones.
  • She will also be my partner in charting the direction of our current and future pipeline.
  • I am excited about the deep capabilities that Dr. Wasilewski will add to the Pulmatrix team as we look to further develop our pipeline."

TFF Pharmaceuticals Announces Final Data from Phase 1b Study of Inhaled Voriconazole Powder in Asthma Patients

Retrieved on: 
Tuesday, December 21, 2021
GLOBE, FDA, Infection, Allergic bronchopulmonary aspergillosis, Absorption, CEO, Annual report, Voriconazole, World Science Day for Peace and Development, Inclusion, Diagnosis, Toxic leukoencephalopathy, NASDAQ, Safety, Science, Inhalation, TFF, Pharmacokinetics, Risk, Infectious Diseases Society of America, Patient, COPD, Asthma, Invasive, Company, Bronchoconstriction, Lung, Cystic fibrosis, Population, Chronic obstructive pulmonary disease, ABPA, Solubility, Bronchospasm, IPA, NCT, Pharmaceutical industry, Aspergillosis

AUSTIN, Texas, Dec. 21, 2021 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced the full readout of safety and pharmacokinetic (PK) data from its Phase 1b study (NCT #04576325) of Inhaled Voriconazole Powder (TFF VORI) in asthma patients.

Key Points: 
  • TFF VORI is a next-generation, direct-to-lung, inhaled dry powder formulation of voriconazole for the treatment and prevention of Invasive Pulmonary Aspergillosis (IPA).
  • TFF Pharmaceuticals proprietary Thin Film Freezing technology platform allows the reformulation of voriconazole into a dry powder with properties ideally suited for inhalation.
  • The data reported from the Phase 1b study are consistent with the initial data reported in November suggesting that TFF VORI is well tolerated in asthma patients and could therefore provide a differentiating benefit to a broad population of patients with IPA.
  • TFF Pharmaceuticalshas two lead drug candidates: Inhaled Voriconazole Powder and Inhaled Tacrolimus Powder.

New England Journal of Medicine publishes positive Phase 3 Dupixent® (dupilumab) results in children with moderate-to-severe asthma

Retrieved on: 
Wednesday, December 8, 2021
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These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product.

Key Points: 
  • These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product.
  • Forward-looking statements are generally identified by the words expects, anticipates, believes, intends, estimates, plans and similar expressions.
  • Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
  • Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed ( http://twitter.com/regeneron ).

Pulmocide Receives Investment from the Cystic Fibrosis Foundation

Retrieved on: 
Monday, December 6, 2021
People, Patient, Lung, Special needs, Oxygen toxicity, CF, Asthma, Chronic pulmonary aspergillosis, Immunodeficiency, Cystic Fibrosis Foundation, Disease, Program, Critical care, Chronic obstructive pulmonary disease, Risk, GLOBE, Incidence, United Kingdom, Â, Allergic bronchopulmonary aspergillosis, Pulmonology, Mortality, Cystic fibrosis, IPA, Azole, Aspergillosis, Pharmaceutical industry

People with cystic fibrosis (CF), particularly those who have undergone lung transplants, are highly susceptible to invasive Aspergillus fungal infections in their airways.

Key Points: 
  • People with cystic fibrosis (CF), particularly those who have undergone lung transplants, are highly susceptible to invasive Aspergillus fungal infections in their airways.
  • The CF Foundations funding will support a multicenter Phase 2 study of Pulmocides opelconazole.
  • The study will assess the treatments safety and tolerability when used to prevent invasive pulmonary fungal infections in lung transplant recipients.
  • Aspergillus infection also plays an important role in severe asthma and cystic fibrosis and has been correlated with poorer clinical outcomes in patients with chronic obstructive pulmonary disease.

TFF Pharmaceuticals Announces Completion of Dosing of Phase 1b Study for Voriconazole Inhalation Powder in Mild to Moderate Asthma Patients

Retrieved on: 
Monday, November 8, 2021
Population, Chronic obstructive pulmonary disease, Bronchospasm, COVID-19, Amikacin, Infection, Voriconazole, Absorption, Bronchoconstriction, Lung, Asthma, Risk, Safety, Allergic bronchopulmonary aspergillosis, Diagnosis, Toxic leukoencephalopathy, BID, ABPA, GLOBE, Patient, FDA, Invasive, IDSA, Phase II, NASDAQ, CEO, VIP, Solubility, IPA, NCT, Pharmacokinetics, Cystic fibrosis, COPD, Â, Severe acute respiratory syndrome coronavirus 2, Niclosamide, Tacrolimus, Annual report, TFF, Company, Inhalation, Pharmaceutical industry

AUSTIN, Texas, Nov. 08, 2021 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced the completion of dosing in the Phase 1b clinical trial of Voriconazole Inhalation Powder (TFF VORI), a next-generation, direct-to-lung, inhaled dry powder version of voriconazole for the treatment and prevention of Invasive Pulmonary Aspergillosis (IPA) (NCT #04576325). This study assessed the safety and tolerability of patients with mild to moderate asthma, a population at high risk of developing IPA, in two cohorts of eight patients. Initial data from the study suggests that TFF VORI is well tolerated in asthma patients, supporting the Company’s progress to Phase 2 study in IPA patients.

Key Points: 
  • This study assessed the safety and tolerability of patients with mild to moderate asthma, a population at high risk of developing IPA, in two cohorts of eight patients.
  • Initial data from the study suggests that TFF VORI is well tolerated in asthma patients, supporting the Companys progress to Phase 2 study in IPA patients.
  • By assessing asthma patients in this Phase 1b reactive airway, we hope to demonstrate that our Voriconazole Inhalation Powder would allow for treatment of patients with IPA that have hyperreactive airway disease comorbidities.
  • This Phase 1b reactive airway study is a randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, pharmacokinetics, and induction of bronchospasm of Voriconazole Inhalation Powder (VIP) in 16 patients with mild to moderate asthma patients.

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

Retrieved on: 
Wednesday, September 15, 2021
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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.