Oslo/Copenhagen, 29 September 2026 – SoftOx Solutions AS (“SoftOx”), a clinical-stage pharmaceutical company developing novel anti-infective therapies for respiratory infections, is pleased to announce that one of the most experienced names in inhaled antimicrobial drug development has agreed to lead SoftOx’s Clinical Advisory Board(CAB).
Dr. Montgomery will work closely with SoftOx to establish and chair the Clinical Advisory Board and assist the Company in bringing together leading international experts within cystic fibrosis, chronic lung infections, inhaled antimicrobial therapy and clinical drug development.
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A principal focus of the Clinical Advisory Board will be to advise SoftOx on the next stage of clinical development of SoftOx Inhalation Solution (SIS), including the design of a planned Phase 2b dose-ranging study in chronic pulmonary infection, with cystic fibrosis currently anticipated to be the lead indication.
Dr. Montgomery brings exceptional experience in the development of inhaled anti-infective therapies and clinical trials in cystic fibrosis. His work spans several decades of clinical drug development, including leadership of landmark programmes that have successfully progressed novel therapies through clinical development, regulatory approval and into clinical use. Most notably, he played leading roles in the development of inhaled antimicrobial therapies including TOBI® (tobramycin inhalation solution) and CAYSTON® (aztreonam for inhalation), treatments that have had a significant impact on the management of chronic lung infections in people with cystic fibrosis. His experience encompasses clinical trial design, regulatory strategy, selection of clinically meaningful endpoints and the translation of promising science into medicines that reach patients.
Thomas Bjarnsholt, CEO/CSO of SoftOx Solutions, commented:
“Bruce joining SoftOx at this stage is a major strengthening of our clinical development capabilities. Few people have his combination of experience in cystic fibrosis, inhaled antimicrobial therapies, clinical trial design and regulatory development.
As we move from Phase 2a proof-of-concept towards defining the next clinical stage for SIS, it is extremely valuable to have Bruce chairing our Clinical Advisory Board. Together, we will build a world-class group of clinical experts and establish the framework for a Phase 2b programme designed to determine the optimal dose and generate the clinical evidence required for subsequent development.
Importantly, Bruce also brings the perspective of someone who has successfully taken inhaled therapies beyond clinical development, through regulatory approval and into the hands of patients. That experience will be highly valuable as we make decisions today that can shape the longer-term development path for SIS.”
Dr. Bruce Montgomery commented:
“I am pleased to join SoftOx as Chair of the Clinical Advisory Board at an important stage in the development of SIS. Chronic pulmonary infections, including those seen in people with cystic fibrosis, remain an area of significant unmet medical need. The prolonged use of antibiotics to suppress chronic airway infections can contribute to the development and selection of antimicrobial resistance, underscoring the need for new and differentiated treatment approaches.
I look forward to working with the SoftOx team and helping to assemble a strong Clinical Advisory Board to advise on the next stage of clinical development. A key focus will be to help define a rigorous Phase 2b dose-ranging programme that can establish the appropriate dose, patient population and clinical endpoints for SIS and provide a solid foundation for subsequent development towards regulatory approval and, ultimately, bringing a new treatment option to patients with chronic lung infections.”
Role and mandate
As Chair of the SoftOx Clinical Advisory Board, Dr. Montgomery will:
assist SoftOx in identifying and appointing appropriate international experts to the Clinical Advisory Board;
chair regular Clinical Advisory Board meetings and participate in additional meetings as required;
advise SoftOx on the overall clinical development strategy for SIS;
provide input into the design of the anticipated Phase 2b dose-ranging programme, including patient population, dose selection, treatment duration, endpoints, microbiological assessments and overall trial design;
advise on the positioning of cystic fibrosis and other chronic pulmonary infections within the longer-term SIS development programme;
provide strategic input on interactions with regulatory authorities and preparation for subsequent clinical development stages; and
provide ad hoc scientific and clinical advice to SoftOx management by meeting or email where appropriate.
The parties anticipate regular Clinical Advisory Board meetings approximately every two months, supplemented by ad hoc discussions when required.
The appointment is advisory in nature. Dr. Montgomery will not have executive or operational responsibility within SoftOx. Any compensation and other contractual terms relating to the appointment will be agreed separately between Dr. Montgomery and the Company.
About Bruce Montgomery
Dr. A. Bruce Montgomery is a physician, biotechnology executive and entrepreneur with more than 35 years of experience in pulmonary medicine and drug development. A recurring theme throughout his career has been taking innovative respiratory therapies from clinical development through regulatory approval and into the market. As Executive Vice President of R&D at PathoGenesis, he led the development of TOBI®, the first FDA-approved inhaled antibiotic for cystic fibrosis. He subsequently founded and led Corus Pharma, which was acquired by Gilead Sciences, and at Gilead successfully led the development of CAYSTON® for cystic fibrosis through approval and commercial launch. Earlier in his career, he co-invented aerosolized pentamidine and was involved in other development programmes that resulted in approved respiratory medicines.
Dr. Montgomery’s career therefore combines deep scientific and clinical expertise in inhaled therapies with the practical experience of building organisations and leading programmes that have converted innovative science into medicines used by patients and families living with serious respiratory disease.
About SoftOx Inhalation Solution
SoftOx Inhalation Solution (SIS) is being developed as an inhaled broad-spectrum anti-infective therapy for chronic respiratory infections. SoftOx is currently conducting its Phase 2a clinical programme in people with cystic fibrosis, with the objective of establishing clinical proof-of-concept and informing subsequent clinical development.
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