Pulmatrix Regains Rights to PUR1800 for COPD, Phase 2 Trial Planned

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by Steve Bryson PhD |

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PUR1800 update

Pulmatrix will regain full rights to its portfolio of narrow spectrum kinase inhibitor (NSKI) medications, including the investigational therapy PUR1800 to treat acute flare in chronic obstructive pulmonary disease (COPD) and other chronic diseases of the airways.

The announcement follows the ending of a license, development, and commercialization agreement with Johnson & Johnson’s Enterprise Innovation, which funded the PUR1800 program, including ongoing Phase 1b and long-term toxicology studies.

Pulmatrix stated it intends to continue developing PUR1800, and plans to announce data from six- and nine-month long-term toxicology studies later this year.

The company also plans to launch a proof-of-concept Phase 2 trial of PUR1800’s efficacy in COPD patients next year.

“Regaining full rights to PUR1800, and the broader portfolio of NSKIs, positions Pulmatrix to independently advance assets that have the potential to address multiple blockbuster markets,” Ted Raad, CEO of Pulmatrix, said in a press release.

“Our prior agreement with Johnson & Johnson greatly advanced our PUR1800 program, fully funding both” the Phase 1b and  toxicology studies. “With data from these studies expected before year-end, we expect to be positioned to advance our planned Phase 2 study in [treating acute exacerbations in people with] COPD,” he added. 

PUR1800 is a narrow spectrum kinase inhibitor that blocks the activity of several enzymes, including p38 MAP kinases, Src kinases, and Syk kinases. These enzymes play critical roles in chronic inflammation and airway remodeling — the ongoing structural changes of lung tissue triggered by disease that causes airways to become thicker and narrower.

COPD is a chronic inflammatory lung disease characterized by cough, wheezing, mucus production, shortness of breath, and chest tightness. Patients can experience acute exacerbations, or episodes of a sudden symptom worsening that may last for several days.

PUR1800 is designed to reduce inflammation and expand the airways, especially in patients whose inflammation is caused by infections or are resistant to steroids. 

The therapy is delivered to the lungs via Pulmatrix’s iSPERSE technology, a proprietary engineered dry powder delivery system in which medicines can be formulated as small, dense particles and dispersed deep into the lungs. The technology has the potential to maximizing local therapeutic concentrations to lessen side effects.

To date, 28-day toxicology studies have been completed. Data from these studies showed that compared to a non-iSPERSE formulated version, PUR1800 led to full body exposure in a dose-dependent manner, had better physical and chemical stability, tended to accumulate less in the lungs, and showed promising potential for long-term dosing.

Dosing is underway in a placebo-controlled Phase 1b trial (NCT04759807) in the U.K., which is evaluating PUR1800 in about 15 COPD patients, ages 40–75. Primary study goals include assessing the incidence of treatment-related adverse events, as well as exploratory biomarkers to determine whether PUR1800 reaches targeted tissues and has an anti-inflammatory effect. 

Top-line study data are expected before the end of the year. This trial may still be enrolling eligible patients at its sole Manchester site; contact other information can be found here.

In addition to PUR1800, Pulmatrix is developing medications for neurologic disorders, such as acute migraine, as well as lung cancer and allergic bronchopulmonary aspergillosis, a condition caused by an excessive immune response in the lungs to the soil fungus Aspergillus

“We look forward to continued progress with PUR1800 and believe our superior iSPERSE formulation has the opportunity to address steroid-resistant and infection-driven inflammation across a diverse range of lung conditions,” Raad added.