News & Events CTI Partners with Pulmotect on Two Phase 2 Trials Targeting COVID-19

CTI Partners with Pulmotect on Two Phase-2 Trials Targeting COVID-19

May 11, 2020

FOR IMMEDIATE RELEASE [Covington, KY ~ May 11, 2020] – CTI Clinical Trial and Consulting Services (CTI), a global, privately held, full-service contract research organization, is partnering with Pulmotect, Inc., a clinical-stage biotechnology company, on two COVID-19 phase 2 clinical trials of Pulmotect’s innate immune stimulating drug PUL-042, entitled:

  • A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2
  • A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection

The trials are for the prevention of infection with SARS-CoV-2 and the prevention of disease progression in patients with early COVID-19 disease. Pulmotect received approval from the U.S. Food & Drug Administration (FDA) earlier this week, and the companies plan to initiate start-up of both trials within the next week at up to twenty U.S. sites. 

“We are thrilled to be working with Pulmotect on these programs,” remarked Timothy Schroeder, CEO of CTI. “The research into PUL-042 for the treatment of patients with COVID-19 is a prime example of how the scientific community can leverage existing science and approach it in an innovative way to develop treatments for novel diseases. We are privileged to be able to help develop these innovative strategies and bring treatments to those in need.”

“We have always considered PUL-042 to have the potential for the prevention and treatment of emerging epidemics and pandemics like the one we currently face,” said Dr. Colin Broom, CEO of Pulmotect. “We are looking forward to working with CTI, who has quickly become a leader in the COVID-19 space, on these important programs.”

Pulmotect’s PUL-042 drug harnesses the power of the innate immune system, the front line of disease defense, to fight off a wide range of respiratory infections. Initially targeted to treat respiratory complications of cancer patient treatment, PUL-042 was well tolerated in three Phase1/2a clinical trials in the U.S. and the U.K. Additionally, PUL-042 has demonstrated compelling protection against a broad range of respiratory pathogens, including the coronaviruses that cause MERS and SARS in preclinical mice models. 

About CTI Clinical Trial and Consulting Services

CTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization. CTI’s focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hepatology, cardiopulmonary, and pediatric populations. CTI also offers a fully integrated multi-specialty clinical research site that conducts phase I-IV trials. CTI has a passion for helping life-changing therapies succeed in chronically and critically ill patient populations. With clinical trial experience across 6 continents, CTI partners with research sites, patients, and sponsors to fulfill unmet medical needs. CTI is headquartered in the Greater Cincinnati, OH area, with operations across North America, Europe, Latin America, and Asia-Pacific. For more information visit


About Pulmotect

Pulmotect is developing PUL-042, a clinical stage, first-in-class, inhaled, immunomodulatory agent. A synergistic agonist that amplifies the innate immune defenses of the lung epithelial mucosa to provide broad-spectrum, pathogen-agnostic protection against respiratory infections. Invented at UT MD Anderson Cancer Center/Texas A&M University, PUL-042 has patents issued in 10 countries, both as a stand-alone composition of matter product and in combination with antivirals. PUL-042 R&D has been supported by the National Institutes of Health (NIAID, NIGMS), the Cancer Prevention and Research Institute of Texas (CPRIT), and other funding agencies. For more information, visit

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