Orthostatic hypertension

Aerami Therapeutics Appoints Joshua Ziel as COO and Interim CEO and Expands Management Team as Lead Asset AER-901 (inhaled imatinib) Advances Toward Phase 2 in Pulmonary Hypertension

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Thursday, June 1, 2023
Molecular biology, Duke University, BS, University, Senior, Allergy, PAH, Biotechnology, Programming Development Manager, WPP, Strategic planning, Doctor of Philosophy, Bachelor of Science, II, Pain, Inflammation, Syneos Health, MD, Patient, Internal medicine, Fatty liver disease, Biology, Acute respiratory distress syndrome, Hospital, Newcastle University, Pulmonary hypertension, Orthostatic hypertension, ChromeOS, Pharmacology, Conatus, Pfizer, Management, Pharmaceutical industry, New York University

Joshua Ziel, PhD was appointed as Chief Operating Officer and will act as Chief Executive Officer as the company advances AER-901 into Phase 2.

Key Points: 
  • Joshua Ziel, PhD was appointed as Chief Operating Officer and will act as Chief Executive Officer as the company advances AER-901 into Phase 2.
  • Additionally, the company has appointed Gary Burgess, MD, as Chief Medical Officer, and Sarah Fritchley, PhD, as Senior Vice President, Clinical Development and Operations.
  • He joined Aerami in 2022 as Vice President for Program Development with oversight on strategy and execution for the AER-901 pulmonary hypertension program.
  • Dr. Fritchley received her BSc degree in pharmacology from the University of Sheffield, followed by a PhD in immunology from Newcastle University.

Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)

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Tuesday, May 30, 2023
PAH, NDA, Janssen, Pulmonary hypertension, Patient, Pulmonary circulation, Tadalafil, Janssen Pharmaceuticals, III, Johnson & Johnson, WHO, ESC, FDA, Orthostatic hypertension, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Constriction, Food, World Health Organization, Pharmaceutical industry

RARITAN, N.J., May 30, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of an investigational single tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) for the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) in adult patients with WHO functional class (FC) II-III.1 The application is based on positive data from the Phase 3 A DUE study, which met its primary endpoint and demonstrated that M/T STCT significantly improved pulmonary hemodynamics (blood flow through pulmonary blood vessels) versus macitentan and tadalafil monotherapies in this PAH patient population.

Key Points: 
  • "Today's submission builds on our decades-long commitment to address patient needs and bring forward medicines with the potential to offer an improved standard of PAH care."
  • Currently, this requires patients to take multiple pills as no single tablet that combines two or more PAH-specific pathways is available for these patients.3
    The NDA is based on late-breaking data from the Phase 3 A DUE study, which met its co-primary endpoints, demonstrating marked pulmonary hemodynamic improvement.
  • The safety profile of M/T STCT was consistent with the safety profile of the individual components, macitentan and tadalafilii,iii.
  • The open label arm of the A DUE study is ongoing.

Aerami Therapeutics Announces Pharmacokinetic Data Demonstrating the Potential of AER-901 (Inhaled Imatinib) to Achieve Therapeutic Levels at Low Inhaled Doses for Treatment of Pulmonary Hypertension

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Wednesday, May 24, 2023
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In addition, preliminary safety findings from the completed AER-901 Phase 1 clinical trial (NCT04903730) were presented.

Key Points: 
  • In addition, preliminary safety findings from the completed AER-901 Phase 1 clinical trial (NCT04903730) were presented.
  • AER-901 is in development to address critical unmet medical need for people with two serious and rare forms of pulmonary hypertension – PAH and PH-ILD.
  • Pulmonary hypertension is a serious complication of ILD for more than 80,000 people in the U.S. and Europe.
  • Full results for the Phase 1 study in healthy volunteers will be presented at a future meeting.

Aerovate Therapeutics Presents Nonclinical Pharmacokinetic Data in Support of AV-101, a Novel Dry Powder Inhaled Formulation of Imatinib, at the American Thoracic Society (ATS) 2023 International Conference

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Monday, May 22, 2023
Rat, Inhalation, PAH, ATS, Pharmacokinetics, American Thoracic Society, Lung, Aerovent, International Conference on Emerging Infectious Diseases, Novartis, Patient, Metabolism, Plasma, Mouse, Orthostatic hypertension, Therapy, Conference, Safety, Pharmaceutical industry

WALTHAM, Mass., May 22, 2023 (GLOBE NEWSWIRE) -- Aerovate Therapeutics, Inc. (Nasdaq: AVTE), a clinical-stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease, today presents results from a series of studies in nonclinical species assessing the pharmacokinetics of different formulations of imatinib at the American Thoracic Society (ATS) 2023 International Conference in Washington, D.C. Aerovate is developing inhaled imatinib as AV-101 for the treatment of pulmonary arterial hypertension (PAH). While oral imatinib has previously demonstrated clinically significant efficacy in PAH patients in the global Phase 3 IMPRES trial conducted by Novartis, the oral formulation was poorly tolerated due to adverse events.

Key Points: 
  • “The results from these nonclinical studies further support our development of AV-101, a dry powder formulation of imatinib administered by inhalation for the treatment of PAH,” said Ralph Niven, Ph.D., Chief Scientific Officer at Aerovate Therapeutics.
  • Repeat dosing of dry powder aerosol to rats and monkeys also suggested concentrations were maintained in the lungs after 24 hours.
  • Plasma time course profiles of imatinib after direct dry powder or suspension dosing in rats were indicative of dissolution-controlled absorption.
  • Aerovate expects to report topline data from the Phase 2b portion of the trial in the second quarter of 2024.

Keros Therapeutics Presents Preclinical and Clinical Data from its KER-012 Program at the American Thoracic Society International Conference

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Monday, May 22, 2023
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“We are pleased to present clinical and preclinical data from our KER-012 program at the ATS conference this year.

Key Points: 
  • “We are pleased to present clinical and preclinical data from our KER-012 program at the ATS conference this year.
  • The preclinical presentations demonstrate observed ligand selectivity of KER-012 and changes in inflammation and fibrosis in models of PAH and cardiovascular diseases.
  • Keros reported preliminary topline data from the Part 1 single ascending dose portion of the trial in May 2022, and additional preliminary clinical data from the Part 2 multiple ascending dose portion of the trial in September 2022.
  • HPAECs and HPASMCs were treated with activin A, GDF11, or bone morphogenetic protein 9 (“BMP9”) in the presence of KER-012.

Gossamer Bio Announces TORREY Data to be Featured at American Thoracic Society 2023 International Conference

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Thursday, May 18, 2023
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Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH), today announced data from its Phase 2 TORREY Study of seralutinib in patients with PAH will be featured in two sessions at the American Thoracic Society 2023 International Conference taking place in Washington D.C. from May 19-24.

Key Points: 
  • Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH), today announced data from its Phase 2 TORREY Study of seralutinib in patients with PAH will be featured in two sessions at the American Thoracic Society 2023 International Conference taking place in Washington D.C. from May 19-24.
  • Dr. Robert Frantz, Director of the Pulmonary Hypertension Clinic and Professor of Medicine at Mayo Clinic will present the data on behalf of the TORREY Study investigators.
  • Presentation Title: Seralutinib Treatment in Adult Subjects with Pulmonary Arterial Hypertension: Results from the TORREY Study
    The presentation and poster will also be made available in the “Posters and Publications” section of the Gossamer Bio website at gossamerbio.com.
  • Following the positive results observed in the TORREY study and discussions with worldwide regulatory authorities, Gossamer plans to initiate a registrational Phase 3 clinical trial in patients with PAH in the third quarter of 2023.

tiakis Biotech AG and Northway Biotech: Successful Tech Transfer and Expansion of Manufacturing Capabilities for Tiprelestat

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Tuesday, May 16, 2023
COVID-19, Clinical trial, Partnership, CDMO, Orthostatic hypertension, Technology transfer, Pharmaceutical industry, Fine chemical

For the first time worldwide, a clinical trial is being supported by Tiprelestat study material produced at an industrial fermentation scale, representing a ten-fold increase in manufacturing potential to 3,000 L.

Key Points: 
  • For the first time worldwide, a clinical trial is being supported by Tiprelestat study material produced at an industrial fermentation scale, representing a ten-fold increase in manufacturing potential to 3,000 L.
    tiakis Biotech AG and Northway Biotech collaboration - tiakis Biotech AG and Northway Biotech:
    "The marked increase in manufacturing capabilities lays the foundation for the next stage of tiakis' development programs, with the recent start of our COMCOVID phase Ib/II clinical trial being a prime example," said Martin Voss, tiakis Biotech AG co-CEO.
  • The enhanced production capabilities is a result of the successful completion of a technology transfer and subsequent ramp-up program, achieved in a short time through close collaboration with end-to-end biologics CDMO Northway Biotech, based in Vilnius, Lithuania.
  • Andre Markmann, VP Business Development of Northway Biotech, added: "This partnership exemplifies our commitment to assist our partners in achieving their objectives by leveraging our technical expertise and operational capabilities.
  • By attaining this pharmaceutical and technological milestone, tiakis and Northway Biotech have demonstrated their capabilities to pave the way towards groundbreaking achievements as pioneers in their respective fields.

Aerovate Therapeutics Announces First Quarter Financial Results and Business Highlights

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Monday, May 15, 2023
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WALTHAM, Mass., May 15, 2023 (GLOBE NEWSWIRE) -- Aerovate Therapeutics, Inc. (Nasdaq: AVTE), a clinical stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease, today announced financial results for the quarter ended March 31, 2023, and recent business highlights.

Key Points: 
  • WALTHAM, Mass., May 15, 2023 (GLOBE NEWSWIRE) -- Aerovate Therapeutics, Inc. (Nasdaq: AVTE), a clinical stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease, today announced financial results for the quarter ended March 31, 2023, and recent business highlights.
  • R&D expenses: Research and development (R&D) expenses for the first quarter ended March 31, 2023 were $13.5 million as compared to $7.3 million for the first quarter ended March 31, 2022.
  • Net loss: Net loss for the first quarter ended March 31, 2023 was $16.5 million as compared to $10.9 million for the first quarter ended March 31, 2022.
  • Net loss included stock-based compensation expense of $2.4 million and $1.0 million for the first quarter ended March 31, 2023 and March 31, 2022, respectively.

Aerami Therapeutics to Present Pharmacokinetic Data Supporting AER-901 (Inhaled Imatinib) for Pulmonary Hypertension at the 2023 American Thoracic Society (ATS) International Conference

Retrieved on: 
Thursday, May 11, 2023
Inflammation, PAH, ATS, Infection, RIS, CMAX, Lung, Washington Marriott Marquis, American Thoracic Society, International Conference on Nuclear Disarmament, Oslo, 2008, MD, Washington Convention Center, Walter, Orthostatic hypertension, Pulmonary hypertension, Therapy, Conference, Pharmaceutical industry

These results, presented by Aerami Chief Medical Officer Gary Burgess, MD, demonstrate the potential to achieve therapeutic lung levels with low inhaled doses of AER-901.

Key Points: 
  • These results, presented by Aerami Chief Medical Officer Gary Burgess, MD, demonstrate the potential to achieve therapeutic lung levels with low inhaled doses of AER-901.
  • AER-901 is entering Phase 2 clinical development for two serious and rare forms of pulmonary hypertension – pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
  • The presentation will take place during the “Showcase Four: Inflammation, Infectious Disease and Other Innovators” session at 2pm EST on May 20.
  • For more information about the ATS International Conference, please visit https://conference.thoracic.org/ .

Gossamer Bio Announces First Quarter 2023 Financial Results and Provides Business Update

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Tuesday, May 9, 2023
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Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH), today announced its financial results for the first quarter ended March 31, 2023, and provided a business update.

Key Points: 
  • Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH), today announced its financial results for the first quarter ended March 31, 2023, and provided a business update.
  • Gossamer plans to report initial results from this ongoing open-label extension trial in the middle of 2023.
  • Financial Results for Quarter Ended March 31, 2023
    Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2023, were $201.9 million.
  • General and Administrative (G&A) Expenses: For the quarter ended March 31, 2023, G&A expenses were $10.1 million, compared to $12.0 million for the same period in 2022.