Quotient & Pulmatrix Announce Completion of Innovative Program
Quotient Clinical and Pulmatrix recently announced the completion of an early clinical program to achieve proof-of-concept data in COPD patients for PUR118, Pulmatrix’s lead iCALM (inhaled dry powder cationic airway lining modulator) therapeutic. The design and preliminary results from this program were presented at the European Respiratory Society (ERS) 2012 conference in Vienna, Austria.
The clinical program was based upon a single, innovative, and flexible clinical design to enable timeline acceleration from clinical entry into initial safety and tolerability evaluation in healthy volunteers, through to pharmacodynamic/efficacy data in mild-moderate COPD patients (GOLD Stages 0-2). Positive proof-of-concept data was achieved in less than 9 months, compared to conventional timelines that can typically stretch to more than 2 years.
“Our work with Pulmatrix has evolved into a landmark case study to illustrate how early development processes and timelines can be expedited,” said Mark Egerton, Managing Director, Quotient Clinical. “This single, four-part protocol seamlessly integrated healthy volunteer and COPD patient investigations by building in flexibility, enabling the project team to rapidly respond to emerging safety and PD data. In addition, an adaptive biomarker strategy encompassing a range of anti-inflammatory, respiratory, and imaging biomarkers was utilized. We are now using this as a model for designing early exploratory and development programs.”
“This innovative, flexible, and adaptive clinical design implemented by Quotient allowed dose-ranging safety and efficacy data to be compiled and understood in a timeframe that was markedly faster than is typical of early-phase clinical drug development. This permitted the potential of our lead iCALM drug candidate, PUR118, to be appreciated much earlier and in greater depth than a conventional path could accommodate,” added John Hanrahan, MD MPH, Chief Medical Officer and Senior Vice President at Pulmatrix.
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