Protalix Biotherapeutics Inc (NYSE-A:PLX) said it is on track to launch a Phase II clinical trial of its experimental gout treatment PRX-115 later this year, as the company builds on momentum from positive early-stage results and rising product sales.
The Israeli biopharmaceutical firm reported first-quarter revenues from product sales of $10 million, up 170% from a year earlier, driven largely by higher sales to Pfizer and Brazil’s Fiocruz.
The strong performance comes as Protalix pushes forward with plans to expand its pipeline, including advancing PRX-115, a recombinant PEGylated uricase designed to lower uric acid levels in patients with uncontrolled gout.
“Given the promising results obtained in 2024 from our first-in-human study of our gout candidate, PRX-115, we are focused on building on the momentum and working toward initiating a phase II clinical trial in patients with gout later this year,” said CEO Dror Bashan.
The candidate, PRX-115, completed a successful first-in-human trial in 2024, with early data suggesting the potential for infrequent dosing — a factor that could support long-term patient adherence.
The company expects to begin the Phase II trial in the second half of 2025. Protalix said additional preclinical assets, including PRX-119 and other early-stage candidates, are also under evaluation for potential development.
While product revenue jumped sharply, the company reported a narrower net loss of $3.6 million for the first quarter, compared to a $4.6 million loss a year earlier. Research and development expenses climbed 21% year over year to $3.5 million as the company ramped up its clinical programs.
In parallel with its proprietary pipeline, Protalix continues to generate modest revenue through its licensing partnership with Chiesi Global Rare Diseases. In March, Chiesi presented new data on pegunigalsidase alfa, a treatment for Fabry disease, at the WORLDSymposium research meeting.
As of March 31, Protalix had $34.7 million in cash, cash equivalents, and short-term deposits.