PUR0200 Shown to Be as Good as Spiriva HandiHaler for COPD in Phase 1 Trial

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by Diogo Pinto |

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Pulmatrix‘s branded generic of Spiriva HandiHaler, called PUR0200, was shown to promote similar improvements in lung function in patients with chronic obstructive pulmonary disease (COPD), but at significantly lower doses than Spiriva, according to a Phase 1 clinical trial.

The study reporting the findings is titled “The pharmacokinetics, pharmacodynamics and tolerability of PUR0200, a novel tiotropium formulation, in chronic obstructive pulmonary disease,” and was published in the British Journal of Clinical Pharmacology.

PUR0200 is a once-daily investigative inhaler medicine and is being developed as an alternative to Spiriva HandiHaler (marketed by Boehringer Ingelheim), which was first approved in the U.S. for the treatment of COPD in 2004.

PUR0200 is a reformulation of tiotropium bromide (also present in Spiriva) combined with Pulmatrix’s iSPERSE delivery system.

iSPERSE consists of salt-based inactive substances that act as the vehicle to deliver the active ingredients, and spray-drying technology for improved delivery to the patient’s lungs.

In the Phase 1 clinical trial (NCT01921712), researchers assessed the safety and effectiveness of PUR0200 in patients with moderate-to-severe COPD and compared it to Spiriva HandiHaler.

Patients received one of three PUR0200 doses — three, six, or nine micrograms tiotropium bromide; Spiriva (18 micrograms tiotropium bromide); or a placebo.

Lung function and blood levels of tiotropium bromide were measured repeatedly during the 24 hours after the treatments were administered.

Results showed that PUR0200 at all doses resulted in a significant improvement in lung function — assessed by an increase in FEV1 (forced expiratory volume in one second) — compared to placebo, and similar dilation of the bronchi (bronchodilation) compared to Spiriva, but at significantly lower doses.

The lowest PUR0200 dose (3 micrograms) — 83 percent lower than the dose of Spiriva — resulted in a similar clinical effect to that of Spiriva, with a more than 30 percent lower blood level of tiotropium bromide.

“The results from this Phase 1 clinical study of PUR0200 are the first clinical demonstration of the delivery advantages of the Pulmatrix iSPERSE technology compared to lactose-based dry powder inhalers,” David Hava, PhD, chief scientific officer of Pulmatrix, said in a press release.

“The ability to achieve similar lung deposition and clinical improvement at reduced exposure to patients highlights the potential of iSPERSE to enable differentiated versions of existing products and to enable new products for the treatment of respiratory disease,” Hava added.

Regarding safety, PUR0200 was generally safe and well tolerated at all doses, compared to Spiriva HandiHaler.

“Tiotropium is a widely prescribed bronchodilator used in the management of COPD often delivered as a dry powder using Spiriva HandiHaler,” said Dave Singh, MD, professor of clinical pharmacology and respiratory medicine at the U.K.’s University of Manchester.

“The clinical data published in the British Journal of Clinical Pharmacology highlight the delivery advantages of PUR0200 and the potential to achieve clinically meaningful improvements in pulmonary function at reduced doses,” Singh said. “In the future, the iSPERSE technology has the potential to enable new formulations of bronchodilators or novel drugs for the treatment of COPD.”

In September 2017, Pulmatrix announced a partnership with Vectura to advance PUR0200 for the U.S. market.