), a clinical stage biotech company, has launched the iSPERSE inhaled dry powder drug delivery platform. iSPERSE’s proprietary cationic salt formulations are spray dried together with a drug or drug combinations to produce dry powders optimized for inhalation that are small in particle size, relatively dense, and highly dispersible.
The iSPERSE technology enables loading more drug into a dose and is relatively independent of flow rate. As a result, high emitted doses can be achieved at low flow rates, such as seen with patients with impaired lung function and with young children.
“iSPERSE provides the unique ability to deliver drugs to the lung much more efficiently and with far less energy on the part of the patient,” says Bob Connelly, Pulmatrix’s CEO.
“Typically, dry powder inhaled delivery technologies currently on the market are only effective with very potent, small molecule drugs. iSPERSE opens the possibility for delivering more types of drug classes, and for replacing cumbersome nebulized delivery with a fast, portable, inhaler application,” Connelly adds.
The technology supports delivery of large molecule drugs such as proteins and peptides and enables delivery of drug combinations in higher doses than is achieved with traditional dry powder lactose blend technologies. The particles can be engineered for localized applications in the lungs, or for systemic delivery such as for pain management or insulin delivery.
“The market is moving toward combination treatments as a means of addressing compliance. With iSPERSE, we have created double, triple, and even quadruple combinations,” Connelly says.
“We view iSPERSE as a platform for building our own portfolio, and we also we expect to partner quite broadly in a range of commercial opportunities,” he adds.
TARGETING UMET NEEDS
Pulmatrix developed the delivery technology in the process of developing its iCALM class of medicines. iCALM drugs are described as “inhaled cationic airway lining modulators.” Pulmatrix first developed iCALM treatments after 9/11 with the goal of making infected persons less contagious to caregivers and others.
“We found that specific types of calcium-based salts interact with the airway fluid to reduce contagion. Out of this initial discovery, we found that iCALM has broad-based anti-infective and anti-inflammatory capabilities, and also enhances the natural clearance function in the lungs,” Connelly says.
Pulmatrix’s iCALM dry powder drug candidate PUR118 is in Phase 1 trials in COPD patients. The inhaler-delivered drug will be tested with cystic fibrosis patients starting this year and has potential also for asthma treatment.
“We are not working directly on the pathogen, but rather PUR118 takes the weapon’s already in the lungs and stimulates the body’s natural immune defenses” in a “host targeted” approach.
“In extensive pre-clinical studies, we have shown PUR118 can prevent and treat a variety of bacterial and biological infections. The therapy triggers a number of effects in the lung that make it more difficult for pathogens to penetrate to a cellular level, increase lung clearance, and boost the lungs’ natural anti-inflammatory and anti microbe capability,” says Connelly. “The biggest problem faced by COPD patients is respiratory infection that can lead to a decline in lung function and death. This is a completely unmet need. Patients can take the PUR line of therapies on a daily basis to prophylactically protect against infection and reduce disease exacerbations.”
The iCALM and iSPERSE platforms are developed to use off-the-shelf, passive inhaler devices. PUR118 is delivered in the trials using the RSO1 inhaler from Plastiape.