Chronic pulmonary aspergillosis

Pulmocide Announces New Clinical Data Confirming Low Potential for Drug-Drug Interactions with Inhaled Opelconazole

Retrieved on: 
Monday, October 16, 2023
ID, Cytochrome P450, Midazolam, Chronic pulmonary aspergillosis, Antifungal, Risk, Inhalation, Disease, Drug, Clinical trial, Bronchospasm, Caffeine, CYP1A2, Patient, CYP3A4, Pharmaceutical industry

The results from these in vitro studies subsequently informed the design of a Phase 1 drug-drug interaction study in 24 healthy volunteers.

Key Points: 
  • The results from these in vitro studies subsequently informed the design of a Phase 1 drug-drug interaction study in 24 healthy volunteers.
  • “Opelconazole was specifically designed to be administered via inhalation in order to achieve high lung concentrations and low systemic uptake.
  • These low systemic levels, now observed in multiple clinical trials and in the UK Special Needs provision, have been estimated to be too low to have an inhibition or induction of a drug-drug interaction effect.
  • We are encouraged that these clinical trial results confirm this low potential for Cytochrome P450 drug-drug interactions for opelconazole.”

TFF Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, August 15, 2023
COPD, Insurance, Calendar, British Aerospace EAP, EAP, Conference call, TFF, SARS-CoV-2, SBIR, National Institute of Allergy and Infectious Diseases, Clinical trial, CRADA, Pharmacokinetics, G&A, Voriconazole, Temperature, Respiratory syncytial virus, Bangladesh Technical Education Board, Medication, Research and development, DARPA, ET, RSV, Patent, Patient, Chronic pulmonary aspergillosis, Administration, NIEHS, Roflumilast, Corporation, PPB, NIAID, R, Leidos, General Administration of Sport of China, Conference, Infection, Pharmaceutical industry, Vaccine, Fine chemical, Security (finance), Cryptocurrency

“We continue to make solid progress in our Phase 2 trials of TFF VORI and TFF TAC and expect to announce initial data by the end of 2023,” said Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals.

Key Points: 
  • “We continue to make solid progress in our Phase 2 trials of TFF VORI and TFF TAC and expect to announce initial data by the end of 2023,” said Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals.
  • We’ve also launched our EAP for TFF VORI and partnered with Durbin to implement the program across several countries.
  • For the quarter ended June 30, 2023, compared to quarter ended June 30, 2022
    Cash Position: as of June 30, 2023, TFF Pharmaceuticals reported cash and cash equivalents of $7.7 million.
  • Net Loss: TFF Pharmaceuticals reported a net loss for the second quarter of 2023 of $5.0 million, compared to a net loss of $8.7 million for the comparable period in 2022.

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
Partnership, EAP, TFF, Expanded access, Aspergillus, Clinical trial, Voriconazole, Allergic bronchopulmonary aspergillosis, Chronic pulmonary aspergillosis, IPA, Patient, Microsoft Access, Special access program, Pharmaceutical industry

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.

Pulmocide Announces Expansion of Management Team

Retrieved on: 
Thursday, June 8, 2023
Management development, GSK plc, Obesity, University, Diabetes, CMC, Respiratory disease, IMD, Drug, Wall Street, MBA, Research, History, Genzyme, UCB, Acquisition, Patient, DSM-IV codes, Chronic pulmonary aspergillosis, Executive Committee, Baxter International, CFO, Kimberly-Clark, Eli Lilly and Company, Executive Committee of the Space Research Council, Financial management, Pharmaceutical industry, Management, Pulmocide, Zealand Pharma

Mr. Dallas brings more than 20 years of financial management experience in the life sciences industry.

Key Points: 
  • Mr. Dallas brings more than 20 years of financial management experience in the life sciences industry.
  • Ashish is a pharmacist by training and earned his MBA from the Institute of Management Development (IMD) in Lausanne, Switzerland.
  • “Matt and Ashish bring a wealth of industry experience as they join Pulmocide and have allowed us to round out our team with the skills necessary to execute our business strategy,” said Daniel Burgess, Chairman and Chief Executive Officer of Pulmocide.
  • Together, the Pulmocide management team has a history of successful company development, including product development and approval, manufacturing, business development, finance, and commercial launch.

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.

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.

Mold contributes to death of COVID-19 Patients, Reports DryMore

Retrieved on: 
Tuesday, October 19, 2021
Atmosphere, Death, COVID-19, Kidney, Chronic pulmonary aspergillosis, Fungus, Aspergillosis, Infection, Patient, Mortality, Voriconazole, Environment, Excellence, Spore, Animal, Pharmaceutical industry, Restaurant

Jessica Lykins, president of DryMore Mold Removal in Houston said high levels of Aspergillus and other mold spores are commonly found in the residential mold inspections they perform.

Key Points: 
  • Jessica Lykins, president of DryMore Mold Removal in Houston said high levels of Aspergillus and other mold spores are commonly found in the residential mold inspections they perform.
  • The common treatment for invasive pulmonary aspergillosis is the use of anti fungal medications such as voriconazole (Vfend)and Amphotericin B.
  • DryMore Mold Removal is a family owned and operated small business servicing the greater Houston and surrounding areas.
  • DryMore Mold Removal has earned an A+ rating and the BBB Award for Excellence for 10+ years.

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
Program, Food, QIDP, Allergic bronchopulmonary aspergillosis, Incidence, Cystic fibrosis, US Foods, CEO, FDA, IPA, Immunodeficiency, Patient, Chronic pulmonary aspergillosis, Mortality, Chronic obstructive pulmonary disease, US FDA, United Kingdom, Review, Critical care, Asthma, Pulmonology, Special needs, Disease, Lung, US, Orphan drug, Pharmaceutical industry

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

Retrieved on: 
Wednesday, September 15, 2021
Goodyear F2G Corsair, European Medicines Agency, Board of directors, DHODH, NDA, QIDP, Mycosis, Antifungal, R, Board, CEO, Patient, Aspergillosis, SVP, McKinsey & Company, Growth, Takeda, Schering-Plough, Partnership, Infection, Camilla, Acquisition, Chronic pulmonary aspergillosis, Orotomide, Coccidioidomycosis, AbbVie, Pharmaceutical industry, Management

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.