Formulation Development and Clinical Testing Service to be Applied to Bronchodilator Therapy

Quotient Clinical has entered a collaboration with Pulmatrix Inc., a biotech company based in Massachusetts, US, to support the development of PUR0200, a new bronchodilator therapy for the treatment of chronic obstructive pulmonary disease (COPD) and the first small molecule product to emerge from Pulmatrix’s inhaled iSPERSE technology platform.

Quotient will employ its RapidFACT (Rapid Formulation development And Clinical Testing) service to manufacture the spray dried PUR0200 product in real time to support the Phase 1B clinical study in COPD patients. This capability allows within-protocol adjustment of the formulation composition in response to arising safety, pharmacokinetic and pharmacodynamic data to optimise performance. The clinical study is being performed at the Quotient Clinical site in Nottingham, UK, and in conjunction with Professor David Singh at the Medicines Evaluation Unit in Manchester, UK.

Mark Egerton, Managing Director of Quotient Clinical, commented: “We are delighted that Pulmatrix has chosen to utilise our RapidFACT service to support the development of PUR0200. We have proven that RapidFACT can shorten timelines and reduce costs in early development, which ultimately contributes to enhancing R&D productivity. This particular study also demonstrates our ability to manufacture and supply drug product in real time to other clinical centres of excellence that specialise in specific disease indications and endpoints.”

Quotient Clinical, +44 115 974 9000, www.quotientbioresearch.com/clinical.