(News Bulletin 247) – The Burgundy firm announces that its Chinese partner Sino Biopharm has obtained the authorizations necessary for the clinical development in China of its treatment against “soda disease”.

While the American health authority expressed serious concerns about the American product Intercept at the end of last week, Inventiva is taking a little more lead in the race to draw first a treatment for non-alcoholic steatohepatitis ( Nash). This pathology is also known as “soda disease”, a pathology characterized by an influx of fat to the liver that can cause damage up to cirrhosis and cancer.

The Burgundian biotech announced Thursday that its Chinese partner Sino Biopharm has obtained the approval of the National Medical Products Administration (NMPA), which allows it to start the clinical development of its flagship compound lanifibranor, in mainland China.

An important step

“This is an important step for us, for our partner Sino Biopharm and for NASH patients in China, who will now be able to take part in a world-class clinical study,” said Frédéric Cren, President- CEO and co-founder of Inventiva.

The American Food and Drug Administration (FDA) had already granted the status of “Breakthrough Therapy” (“particularly innovative treatment”) for the Inventiva molecule following the publication of positive results from the first clinical studies.

Under the proposed clinical program, Chia Tai Tianqing Pharmaceutical Group (CTTQ), a subsidiary of Sino Biopharm, will enroll patients in China in the global Phase III clinical trial (last step before potential marketing) NATiV3 in course, the results of which, if positive, should support a request for marketing authorization in China, the United States and Europe. In parallel, CTTQ will conduct a phase I clinical pharmacology study to evaluate the pharmacokinetics of the 800 mg/day and 1200 mg/day doses of lanifibranor in healthy Chinese subjects.

Inventiva further indicates that it is “eligible” to receive one of the two milestone payments totaling $5 million, provided for in the agreement signed with Sino Biopharm in September 2022. These payments could reach up to $290 million to develop and commercialize lanifibranor in China. The group expects the publication of the first results of the NATiV3 study part 1 in the second half of 2025.

News hailed on the stock market

During its update on its activities published on May 17, the biotech estimated that its cash flow – of 56.3 million euros at the end of March – should allow it to finance its activities until the fourth quarter of 2023. This estimate of cash flows cash flow does not take into account the second tranche of the loan from the European Investment Bank (EIB) for an amount of 25 million euros, the disbursement of which is subject to the full use of the first tranche in addition to the achievement of certain goals.

This EIB financing was obtained in May 2022 as part of a loan for a total amount of 50 million euros, the reimbursement of interest and capital of which will take place after the completion of phase III clinical trials. This is one of the “most important financing granted by the European Investment Bank to a biotech”, then specified its financial director, Jean Volatier.

On the Paris Stock Exchange, investors appreciate Inventiva’s progress in its treatment against “soda disease”, cirrhosis due to fat and sugar. The title of the biotech both listed in Paris and New York rose by 7.8% to 2.8 euros around 10:30 a.m., an increase which allowed it to relaunch on the stock market while it still showed a decline of 37% since the beginning of the year.