A new drug called PUL-042, currently under development at Texas A&M Health Science Center and University of Texas MD Anderson Cancer Center, is now in a Phase 1 clinical trial with indications for boosting the immune system against deadly epidemics and bioterrorism threats.
Since it is a Phase 1 trial looking at safety, tolerability, pharmacokinetics, and pharmacodynamics, healthy participants are being recruited for the study at ICON Development Solutions in San Antonio. Eventually, the research team, who is working with Houston-based Pulmotect Inc. on the trial, hopes to use PUL-042 to stimulate the immune system against infectious diseases in patients susceptible to illness, such as cancer patients. “Patients receiving chemotherapy are highly susceptible to life-threatening respiratory infections, including pneumonia, while in their immune-compromised state,” said Magnus Höök, PhD, co-founder of Pulmotect and a professor at Texas A&M, in a news article. “PUL-042 holds promise to protect these patients from deadly infection during their most vulnerable period, allowing for significantly higher treatment success.”
According to Dr. Höök, PUL-042 is an inhalant designed to prime the body’s innate immune system and provide short-term protection against bacterial, fungal, and viral pathogens. It is effective for up to four days against infections and might also fight seasonal and pandemic influenza viruses and asthma attacks. “The lungs are the point of entry for many viruses and bacteria. We hypothesized that activating the innate immune defense of the lungs might provide effective protection against a wide range of deadly pathogens,” said Dr. Höök in a press release.
Dosing for the present trial consists of administering specific combinations of Pam2CSK4 acetate and ODN M362 via nebulization. Participants will be evaluated for hypoxia, forced expiratory volume in one second (FEV1), bronchospasms, and wheezing. The research team says two rounds of clinical trials will assess the safety and tolerability of PUL-042, and they will also analyze its effectiveness in cancer patients. They predict the drug could be marketed within the next four or five years.
“A development seven years in the making, we are delighted to see the technology advancing into clinical trials, moving us one step closer toward our end goal: Bringing this protective therapy to the market to save lives and address a critical unmet need worldwide,” said Dr. Höök. “Ultimately, this drug has the potential to alter our vulnerability to deadly epidemics and bioterror threats.”