- The stock price of Xenetic Biosciences, Inc. (NASDAQ:XBIO) are trading at over 300% as it went from $1.08 in the previous close to $4.88 as of 11:17 AM ET. This is why it happened.
The stock price of biopharmaceutical company Xenetic Biosciences, Inc. (NASDAQ:XBIO) are trading at over 300% as it went from $1.08 in the previous close to $4.88 as of 11:17 AM ET. The main trigger for why the stock price is surging is an announcement from the company that it saw positive data from its partner PJSC Pharmsynthez about its pivotal Phase 3 clinical study leveraging PolyXen to develop a treatment for anemia in patients with chronic kidney disease (CKD).
PolyXen is Xenetic’s patent-protected platform technology designed for protein or peptide therapeutics, which enables next-generation biological drugs by prolonging a drug’s circulating half-life and potentially improving other pharmacological properties. And the PolyXen technology platform was used by Pharmsynthez to develop Epolong (also known as ErepoXen or PSA-EPO), a polysialylated form of recombinant human erythropoietin, a hormone produced by the kidneys to promote blood cell production. And Pharmsynthez reported in its press release that Epolong is under investigation with the goal of reducing the required dosing frequency and reducing potential side effects, as compared to existing EPO products.
In the press release issued by Pharmsynthez, it was revealed that the pivotal Phase 3 multi-center randomized study was conducted in Russia by Pharmsynthez and was designed to study the efficacy, safety and tolerability of Epolong in comparison with Aranesp (darbepoetin alfa), the current leader in the long-acting erythropoietin segment. And the study enrolled approximately 150 patients with CKD across 36 medical institutions.
The results of the study indicated that Epolong was non-inferior to Aranesp with respect to primary and secondary endpoints. And the proportion of patients who achieved the target hemoglobin range (10.0-12.0 g/dL inclusive) during the evaluation period was 74% in the Epolong group versus 52% in the Aranesp group. Plus Pharmsynthez also reported that the study revealed that the proportion of patients who exceeded the target threshold level of hemoglobin (12.0 g/dL) was 3.5 times greater in the Aranesp group than in the Epolong group (34.7% versus 10.0%, respectively).
In clinical and preclinical settings, therapeutic proteins polysialylated with the PolyXen platform have been shown to have extended circulating half-life, improved thermodynamic stability and resistance to proteases while also retaining pharmacological activity. And PolyXen has been demonstrated in human clinical trials to confer prolonged half-life on biotherapeutics such as recombinant human erythropoietin and recombinant Factor VIII (rFVIII). PolyXen has potential utility in other molecule classes like peptides and small molecules. The company is utilizing its PolyXen technology through an exclusive license agreement with Takeda Pharmaceuticals Co. Ltd. in the field of coagulation disorders and receives royalty payments under this agreement.
“The PolyXen platform continues to demonstrate broad utility and ability to modulate the pharmacokinetic and pharmacodynamic profiles of protein drugs. We are pleased with the positive results Pharmsynthez has reported and we look forward to the outcome of their registration filing in Russia for Epolong, which they expect to submit in 2021.”
— Jeffrey Eisenberg, Chief Executive Officer of Xenetic.
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