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21.400 EUR
indice de référenceSBF 120

FR0004163111 GNFT

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GENFIT : Seekin Alpha 24/04 8h28 PM

25 avr. 201908:15

Genfit received Breakthrough Therapy Designation from the FDA for its Elafibranor to treat patients with primary biliary cholangitis.

The Breakthrough Designation was given because, both the 80 mg and 120 mg doses of Elafibranor were shown to achieve significant changes in ALP compared to placebo in 12 weeks.

Genfit expects to release results from its phase 3 NASH study using Elafibranor, at an interim analysis at week 72, by the end of 2019.

Meeting the primary endpoint for the phase 3 interim analysis will mean potential accelerated approval for both the U.S. and European territories.

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Genfit (GNFT) announced that it had received Breakthrough Therapy Designation for its drug Elafibranor to treat patients with primary biliary cholangitis (PBC). The designation was given based on newly updated data presented at the EASL International Liver Congress 2019. This will help Genfit speed up the review process for potential FDA approval. A competing drug from Intercept Pharmaceuticals (ICPT), known as Ocaliva, has already been approved by the FDA to treat patients with PBC.

Breakthrough Designation Based On Impressive Data
Elafibranor was given Breakthrough Therapy Designation based on positive phase 2 results. These results were presented at the EASL medical conference, which were deemed to be the "Best of ISL" 2019. The new phase 2 study data showed that PBC patients treated with Elafibranor saw improvements in multiple measures (including biomarkers) compared to placebo. The phase 2 study was a 12-week long study in which patients were randomized to receive either 80 mg of Elafibranor, 120 mg of Elafibranor, or placebo. One item to note is that these patients were those who didn't have an adequate response to ursodeoxycholic acid (UDCA). In other words, these patients were at an alkaline phosphatase (ALP) level that was greater than 1.67 the upper limit of normal. Why is a high ALP level in the patient's body a big problem? When ALP levels in the blood are higher, it is said that the liver cells are damaged. The higher the ALP levels noted, the higher the damage of the liver. As you can see above, the patients recruited into the study were those with abnormal levels of ALP in the blood. It is important to note that along with Elafibranor patients continued to take UDCA. It was not stopped, it was just given alongside Elafibranor to improve clinical outcomes. The primary endpoint was evaluating to see what ALP change could be achieved from baseline to week 12 with Elafibranor. It was noted that both doses of the drug were able to achieve a significant decrease in ALP compared to placebo. Patients that took 80 mg and 120 mg of Elafibranor saw a decrease in ALP by -48% and -41%, respectively. On the other hand, placebo not only came nowhere near those reductions but it even caused ALP levels to increase. It was shown that those patients treated with placebo saw in increase in ALP by 3%. In other words, heading in the wrong direction.

Catalyst For Upcoming Phase 3 Readout
Genfit is doing phenomenal on the PBC front. However, it's an important year for the biotech because of upcoming NASH data. It expects to reveal results from its phase 3 study using Elafibranor to treat patients with NASH fibrosis by the end of the year. This phase 3 NASH study recruited patients with F2 and F3 fibrosis. Patients will either receive 120 mg of Elafibranor or placebo. This is a solid study, because it was designed with an interim analysis in mind. At the end of 2019, a 72-week interim analysis will be done to determine if Elafibranor ends up meeting the primary endpoint of this study. The primary endpoint is the usual one for NASH studies, which is NASH resolution without worsening of fibrosis. If this endpoint is met, then Genfit can possibly seek accelerated approval for its NASH drug in both the U.S. and European territories. I think that Genfit should do fairly well. That's because Elafibranor is established both as an anti-NASH and anti-fibrotic drug. The same can be said about a competitor known as Intercept Pharmaceuticals. It also addressed both underlying issues with NASH. The downside for Intercept is that it reported mixed results for its interim analysis of a phase 3 NASH study using its drug Ocaliva. It was able to achieve statistical significance for an improvement of fibrosis, but not for NASH resolution. Genfit has an opportunity to shine with both endpoints. Another item to note is that Genfit evaluating Elafibranor as a backbone treatment with other drugs. This is an important task, because new combinations can be formed to treat patients with NASH.

Genfit had $233.3 million in cash as of December 31, 2018. It has an extensive pipeline of NASH candidates. The ongoing phase 3 study for NASH is a very large one. In addition, it is even running a phase 2 study using Elafibranor to treat pediatric patients with NASH. The biotech has even gone as far as to develop a new molecule for fibrosis, known as nitazoxanide. This drug is specifically being developed as purely an anti-fibrotic. This is currently being explored in a phase 2a investigator-sponsored study. In my opinion, considering that Elafibranor could be used as a backbone product for a combination, it might be prudent to combine it with nitazoxanide. Since nitazoxanide is only focused as an anti-fibrotic, that would be a good idea to combine it. For now, it depends on how the good the results turn out to be in the phase 2a study. Considering that Genfit has all these trials going on, its cash wasn't sufficient to last. That's why it enacted a global offering in which it raised $155.4 million. That means the current cash on hand is at $388.7 million. I don't believe the company will need to raise any cash in the near term.

The Breakthrough Therapy Designation for Elafibranor will allow Genfit more interaction with the FDA as it gets the drug through the remaining stages of the approval process. The designation was given based upon positive data, where both doses of Elafibranor, were able to achieve a significantly better decrease in ALP compared to placebo. The risk with this program is that it is still only in a phase 2 study. There is no guarantee that results from this phase 2 study will be reproduced again in a larger study. The phase 3 readout for Elafibranor in NASH serves as the basis for potential accelerated approval in two territories. The risk is that there is no guarantee that the primary endpoint will be met. In that case, Genfit may have to wait until the entire study is completed with extended data to determine its next move. That means it could take a few more years if that happens. I believe that Genfit is in good shape, because it has a diversified NASH pipeline.

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5 réponses

  • ch.busso
    25 avril 201908:46

    Nickel... more and more each day ;-) on croise les doigts !

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  • TF85800
    25 avril 201909:42

    hausse du titre importante; 1ère étape fin 2019(résultat phase3), 2ème étape fast track donné par FDA fin T1 2020
    Objectif T2 2019 :63 € mini si ce n'est avant. Achetez!!

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  • LouDel19
    25 avril 201910:02

    allez ! zou

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  • Haaaa
    25 avril 201910:16

    GO ont achètent
    Ont va la faire partir bon diou

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  • Ytre123
    25 avril 201914:19

    excellente synthèse de la situation

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