Micro cap Protalix BioTherapeutics (NYSEMKT:PLX) is up 8% premarket on robust volume in response to its announcement of positive results from a 16-subject Phase 2 clinical trial evaluating AIR DNase (alidornase alfa) in cystic fibrosis (CF) patients previously treated with Roche's (OTCQX:RHHBY) Pulmozyme (dornase alfa).
Preliminary data showed patients treated with alidornase alfa experienced a clinically meaningful improvement in lung function as measured by the percent increase in percent predicted forced expiratory volume in one second (ppFEV1) of 3.4 points from baseline. Participants also showed a mean absolute increase of 2.8 points in ppFEV1 compared to the measurements taken when patients switched from Pulmozyme to alidornase alfa.
A correlation between sputa parameters and pulmonary function was observed. The sputa DNA content in ~half the patients was analyzed which showed an average reduction of over 70% from baseline. There was more than a 90% reduction from baseline in sputa visco-elasticity.
An in vitro study showed alidornase alfa significantly inhibited the bacterium Pseudomonas aeruginosa, a major cause of lung infection in CF sufferers.
More complete data will be presented at the 40th European Cystic Fibrosis Conference in June.
According to the company, AIR DNase is a proprietary plant cell-expressed recombinant form of a human enzyme called deoxyribonuclease 1 (DNase 1) that cleaves extracellular DNA and thins the thick mucus that accumulates in the lungs of CF sufferers. It is designed to be more effective than Roche's Pulmozyme by being more resistant to actin inhibition, which restricts DNase I activity. Actin is a protein that plays a role in a wide range of cellular processes.