The next-generation biotech company Abionyx (the result of the repositioning of Cerenis, which has changed shareholders, strategy, and management team following its failure to treat cholesterol) is back in the spotlight. After years of stock market decline following the failure of its initial positioning, the company is back on the stock market this year. At around 10:50 a.m. on Thursday, November 26th, its share price soared by 40.52% to $1.290 (€1.082), bringing its rebound since January 1st to more than 220%.
This acceleration follows the announcement of positive therapeutic signals from the administration of its investigational compound CER-001 in patients with ultra-rapid kidney disease (ultra-rapid refers to diseases diagnosed in only a few dozen people worldwide each year).
These data do not allow a definitive conclusion to be drawn regarding the efficacy endpoint of CER-001 at this time, but the product is likely to be of benefit to patients with severe kidney disease without existing treatment.
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Patients no longer on dialysis
The company had received in January and February, in France and Italy, a Temporary Named Use Authorization (TUA) for CER-001 in an ultra-rapid kidney disease without existing treatment. These nominative TUEs (as opposed to cohort TUEs) make it possible to treat a named patient. They were issued at the request and under the sole responsibility of prescribing physicians who believed that CER-001 was likely to be of benefit to the patient.
The data collected after administration of the treatment in these two ATUns corroborate “promising therapeutic activity of CER-001 in the progression of ultra-rare kidney disease” (not disclosed at this time). “Due to the severity of their kidney disease, patients who were on the verge of dialysis were not on dialysis during their treatment with CER-001. These therapeutic signals on CER-001 confirm the value of CER-001 for use in severe indications, primarily renal at this time,” said Abionyx.
“Medical needs remain very high”
In studies currently being analyzed by peer-reviewed journals, researchers have shown that high-density lipoproteins (or HDL, CER-001 being a mimetic of HDL, also known as “good” cholesterol) have a major anti-inflammatory role and impact on kidney function. Several models of kidney disease have shown that HDLs stimulate kidney remodeling, a critical factor contributing to disease progression.
The analysis of the data collected will lead to scientific publication and Abionyx will share these results with regulatory authorities in order to redefine the development plan for CER-001 in the treatment of kidney disease without existing treatment.
“We are more than ever committed to the continued development of our biotech assets and the development of drugs for renal diseases without effective treatment, where medical needs remain very high,” said CEO Cyrille Tupin.
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This article may include forward-looking statements. These forward-looking statements generally are identified by the words “believe,” “project,” “estimate,” “become,” “plan,” “will,” and similar expressions. These forward-looking statements involve known and unknown risks as well as uncertainties, including those discussed in the following cautionary statements and elsewhere in this article and on this site. Although the Company may believe that its expectations are based on reasonable assumptions, the actual results that the Company may achieve may differ materially from any forward-looking statements, which reflect the opinions of the management of the Company only as of the date hereof. Additionally, please make sure to read these important disclosures.
First published in BFM BOURSE, a third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.
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