Protalix BioTherapeutics, Inc. has established a new strategic approach with the purpose of accelerating its growth while continuing to focus on prioritizing both its new pipeline drug candidates as well as currently available therapies. The company wants to center its work on “bio-better” products that are able to offer superior clinical profiles and competitive characteristics. Among its leading products is AIR DNase, a potential treatment for cystic fibrosis (CF).
Protalix’ mission is to develop and commercialize recombinant therapeutic proteins using their proprietary expression system based on plant cells, called ProCellEx. Starting from this principle, the company has created therapeutic options for several conditions, including cystic fibrosis. AIR DNase (PRX-110) for CF, its actin inhibition resistance, has been designed to ameliorate lung function as well as reduce infections incidence.
The lead candidate is expected to improve CF patients’ lung function by enhancing the enzyme’s efficacy in patients’ sputa. It has been proven effective in improving the disease symptoms when tested in animal models and human sputum testing, compared to the therapeutic options currently available in the market.
As a result, the company plans to initiate AIR DNase clinical efficacy trials this year for the treatment of Cystic Fibrosis in a non-IND setting, as announced in a press release. In addition, Protalix expects to review the first results of the study by the beginning of 2016, as well as to look for a partner to support the development of the therapy.
“We are very excited with our new path forward as there are a number of key value creating milestones that have the potential to significantly increase shareholder value,” stated the President and CEO of Protalix, Moshe Manor. “We will have three molecules in clinical trials in 2015 which will all report efficacy data over the next 15 months, and collectively target markets over $5 billion. We have a strong cash position of approximately $54 million which will provide the financial resources necessary to implement our strategic objectives.”
In addition to CF, the company is also directing its work to drive its lead enzyme replacement therapy for the treatment of Fabry disease, called PRX-102, to clinical development. Clinical efficacy trials of Oral Anti-TNF for the treatment of Inflammatory Bowel Disease (IBD) in a non-IND setting will also be initiated during 2015.