FRANCE – French Pharma giant Sanofi has halted development of lademirsen, discovered by Regulus Therapeutics, after the program failed a Phase II interim analysis.
Sanofi added that the move was not due to safety concerns. Lademirsen is designed to slow kidney function decline in patients with Alport syndrome.
Alport syndrome is a disease in which patients experience progressive loss of kidney function, hearing loss and eye abnormalities.
A spokesperson for the French pharma confirmed in an email to Fiercepharma that development would end, including the early termination of a phase 2 trial called HERA.
The company made the decision after an interim analysis showed treatment with lademirsen did not lead to a meaningful improvement in kidney function compared with placebo.
The analysis came from 24 patients who had completed the 24-week, double-blind treatment period.
Despite the trial failure, the spokesperson said that Sanofi remains “committed to advancing new therapies for rare kidney diseases.”
Regulus’ shares tumbled about 7% Monday afternoon to US$2.17 as per Fiercepharma. The news of Sanofi’s move away from lademirsen was disclosed by the biotech in a regulatory document.
Alport syndrome is a disease in which patients experience progressive loss of kidney function, hearing loss and eye abnormalities.
Had the HERA study been successful, Regulus would have been eligible for a US$25 million milestone payment upon proof of completion.
Sanofi and Regulus have worked together for more than a decade on microRNA and oncology therapeutics.
The Sanofi spokesperson could not confirm the status of any remaining programs with Regulus, but lademirsen is the only therapy from the partnership that Regulus has noted on recent earnings releases.
Regulus banked US$10 million in enrollment and other milestones from Sanofi for its miR-21 programs in 2020, specifically for RG-012, which later became known as lademirsen.
Full results for the HERA study were expected in the first half of 2023.
The lademirsen setback is just the latest for the small biotech, which reshuffled its pipeline for the third time in October 2021 to try to turn the ship around.
At that time, Regulus planned to refocus on kidney disease candidate RGLS8429 after a similarly named treatment called RGLS4326 was unsuccessful in clinical testing and spurred same safety red flags.
Sanofi offloads 17 drugs to Neuraxpharm
Meanwhile, Sanofi has entered a deal to hand over 17 products to central nervous system (CNS) specialist Neuraxpharm for an undisclosed sum, Fiercepharma reports.
The drugs comprise two product portfolios for CNS disorders, pain and vascular diseases, Neuraxpharm said in a release.
The first portfolio consists of 15 meds for CNS disorders across psychiatry and neurology, Neuraxpharm explained.
The roster includes drugs such as Nozinan, Tranxene, Tiapridal, Dogmatil and Largactil, which address diseases like depression, anxiety, psychosis, alcohol dependence, myasthenia gravis and Parkinson’s disease.
The pain and vascular portfolio, for its part, is made up of just two drugs: Topalgic and Trental.
Together, that suite of products is marketed globally in more than 50 countries, Neuraxpharm added. The 17 Sanofi molecules together make up 38 brands.
Neuraxpharm says it inked the deal as a means to cement its position as one of the top CNS-focused specialty pharmas in Europe.
Once armed with Sanofi’s 17-product arsenal, Neuraxpharm expects its yearly gross sales to clock in at around 600 million euros (US$614.7 million).
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