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.