Protalix Biotherapeutics Inc (NYSE-A:PLX) announced plans to advance its experimental gout treatment PRX-115 to Phase II clinical trials later this year, building on positive early-stage results and a significant increase in product sales during the first quarter of 2024.
The Israeli biopharmaceutical company reported first-quarter revenues from product sales of $10 million, representing a 170% increase compared to the same period last year. This growth was primarily driven by higher sales to pharmaceutical partners Pfizer and Brazil's Fiocruz.
"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 Dror Bashan, CEO of Protalix Biotherapeutics.
PRX-115: A Novel Approach to Gout Treatment
PRX-115 is a recombinant PEGylated uricase designed to lower uric acid levels in patients with uncontrolled gout. The drug candidate successfully completed its first-in-human trial earlier this year, with preliminary data suggesting potential for infrequent dosing—a significant advantage that could support long-term patient adherence.
Gout affects approximately 9.2 million adults in the United States alone, characterized by painful inflammation of joints due to elevated uric acid levels. Current treatments often face challenges with adherence and efficacy in severe cases, creating a substantial unmet need for new therapeutic options.
The mechanism of PRX-115 targets the underlying cause of gout by breaking down uric acid, potentially offering a more effective approach for patients who don't respond adequately to conventional treatments such as xanthine oxidase inhibitors.
The company expects to initiate the Phase II trial in the second half of 2025, focusing on patients with uncontrolled gout who have limited treatment options.
Financial Performance and Pipeline Development
While product revenue increased substantially, Protalix reported a narrower net loss of $3.6 million for the first quarter, compared to a $4.6 million loss in the same period last year. Research and development expenses increased by 21% year-over-year to $3.5 million as the company expanded its clinical programs.
"Our strong financial performance this quarter provides us with the resources to advance our pipeline while maintaining operational efficiency," Bashan noted during the company's earnings call.
In addition to PRX-115, Protalix is evaluating several preclinical assets, including PRX-119 and other early-stage candidates, for potential development. These programs represent the company's strategy to build a diverse portfolio of novel therapeutics using its proprietary ProCellEx® plant cell-based protein expression system.
Partnership with Chiesi and Rare Disease Focus
Alongside its proprietary pipeline development, Protalix continues to generate 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.
Fabry disease is a rare genetic disorder that affects approximately 1 in 40,000 to 60,000 males, with variable prevalence in females. The condition results from deficient activity of the enzyme alpha-galactosidase A, leading to accumulation of glycosphingolipids in various tissues and organs.
The collaboration with Chiesi represents Protalix's established presence in the rare disease space, while the development of PRX-115 for gout signals the company's expansion into more prevalent conditions with significant unmet needs.
Financial Position and Outlook
As of March 31, 2024, Protalix maintained a solid financial position with $34.7 million in cash, cash equivalents, and short-term deposits. This capital is expected to fund the company's operations and clinical development programs through key milestones.
The advancement of PRX-115 into Phase II trials marks a significant step in Protalix's growth strategy as it seeks to leverage its proprietary technology platform to address both rare and more common diseases with substantial unmet medical needs.
Industry analysts note that the gout treatment market is projected to grow significantly in coming years, potentially reaching $9.5 billion by 2030, providing Protalix with a substantial commercial opportunity if PRX-115 continues to demonstrate promising results in later-stage trials.
