Inventiva provides an update on its NATiV3 clinical program evaluating lanifibranor in patients with MASH/NASH and its financial position
Fast TrackClinical ResultBreakthrough Therapy
Recruitment in NATiV3 clinical trial continues in both cohorts with over 80% of the targeted number of patients enrolled in the main cohort and 100% in the exploratory cohort of NATiV3.
Analysis of the baseline characteristics of all patients randomized in the main cohort of NATiV3 show a patient profile similar to patients randomized in the NATIVE Phase IIb clinical trial.
A blinded analysis of all randomized patients suggests weight gain plateaus and stabilizes between week 24 and 36.
First visit of the last patient of NATiV3 is anticipated to occur during the second half of 2024, and topline results are expected at the beginning of the second half of 2026.
Patent portfolio strengthened with new patent secured protecting the compound until 2043.
The Company is currently working on multiple fronts to secure financing to fund the continuity of its activities.
July 5, 2024 – Inventiva (Euronext Paris and Nasdaq: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of patients with metabolic dysfunction-associated steatohepatitis (“MASH”), also known as non-alcoholic steatohepatitis (“NASH”), and other diseases with significant unmet medical needs, today provided an update on its clinical program evaluating lanifibranor for the treatment of MASH/NASH and its financial position.
Frederic Cren, Chairman, Chief Executive Ofiicer, and cofounder of Inventiva stated : "We have made good progress with the recruitment in our Phase III clinical trial and continue to see a strong engagement of clinical trial sites in NATiV3. We are encouraged by the patient characteristics we are seeing in the main cohort of NATiV3 compared to those of our Phase IIb trial and above all by the plateau effect we see in the weight gain curve which confirms the differentiated profile of our panPPAR compound versus single PPAR gamma compounds such as pioglitazone. The data obtained from our various clinical studies demonstrate that lanifibranor could fully address the broad spectrum of the disease and recent presented data at the EASL Liver Congress from other compounds in development further bolster our belief in the potential of oral lanifibranor for use alone or in combination therapy. We are continuing to evaluate financing options to extend our current cash runway and continue our activities as we are determined to bring lanifibranor to market as a treatment option for patients with MASH.”
Update on its clinical program evaluating lanifibranor for the treatment of MASH
The recruitment in NATiV3 is advancing with screening ongoing at 347 sites across 19 countries. As of July 5, 2024, 1,027 patients have been randomized of which 784 patients in the main cohort of NATiV3, representing 82% of the targeted number. The geographical distribution of the main cohort confirms that North America and Western Europe are the key contributors to patient recruitment (67% and 21% respectively) while China has only contributed marginally (2% of patients). The targeted number of 200 patients to be recruited in the exploratory cohort has been met with 243 patients randomized to date. The recruitment in the exploratory will continue until recruitment is complete in the main cohort.
The Company estimates that, given the number of patients currently in screening who are eligible for enrolment in the main cohort, the Company must recruit an additional 165 patients. Due to a delay of approximately 3 to 5 months in recruitment, the Company is currently now targeting: the last patient first visit for the second half of 2024 and the publication of the topline results in the beginning of the second half of 2026.
The baseline characteristics of the patients enrolled so far in the main cohort are in line with the expectations of the Company and are consistent with those from the NATIVE Phase IIb clinical trial of lanifibranor in patients with MASH/NASH (“NATIVE”). In addition, 13% of patients enrolled in the main cohort were receiving a stable dose of GLP1 receptor agonist and 9% a stable dose of SGLT2 inhibitors at baseline and should provide the Company with insights on the potential of the benefits of a combination of these class of products with lanifibranor.
Importantly, a blinded review which included 780 patients enrolled in the main cohort of NATiV3 (placebo and treatment arms pooled) showed a similar weight gain as the one observed during the NATIVE Phase IIb trial which seems to plateau and stabilize after 24 to 36 weeks of treatment, and this even in the subgroup of patients who have gained more than 5% weight. If confirmed, this encouraging result highlights the particular profile of lanifibranor versus single PPAR gamma in particular pioglitazone, where such a plateau effect has not been observed1.
Intellectual property strategy
We continue to work to reinforce lanifibranor patent portfolio. As of today, lanifibranor patent portfolio is made up of 20 patent families comprising both patents and patent applications fully owned by Inventiva. These patent families are respectively directed to lanifibranor product, method of treatment, combination therapy, process, formulation and diagnostic methods. With our patent family directed to crystalline forms of lanifibranor (patent applications pending), the company expects to potentially extend protection on lanifibranor product until at least 2043.
Financial update
Considering the Company’s cost structure and forecasted expenditures, and without taking into account additional cash preservation measures that the Company may implement in the short term, the Company estimates that its cash, cash equivalents and deposits will allow the Company to fund its operations as planned through the second half of July 20242. The Company estimates that, as of May 31, 2024, the Company’s cash and cash equivalents were (non-audited) €9.6 million, short-term deposits were €0.1 million3, and long-term deposits were €10.0 million4, compared with €26.9 million, €0.01 million and €9 million, respectively, as of December 31, 2023.
In order to finance its activities and advance its development objectives for its research and development programs, the Company will need to raise additional funds. To date, the Company has explored a variety of transactions, including the issuance of debt, equity and other instruments, which thus far have not been successful. However, the Company is working to complete a royalty-based financing that would extend its cash runway through the summer of 2024, which it anticipates announcing in the near-term. Even if the royalty-based financing is successful (of which there can be no assurance), the Company will need to raise additional funds, and it is continuing to actively evaluate potential financing (including debt, equity and equity-linked or other instruments) and strategic options.
About lanifibranor
Lanifibranor, Inventiva’s lead product candidate, is an orally-available small molecule that acts to induce antifibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three peroxisome proliferator-activated receptor (“PPAR”) isoforms, which are well-characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well-balanced activation of PPARα and PPARδ, and a partial activation of PPARγ. While there are other PPAR agonists that target only one or two PPAR isoforms for activation, lanifibranor is the only pan-PPAR agonist in clinical development for the treatment of MASH/NASH. Inventiva believes that lanifibranor’s moderate and balanced pan-PPAR binding profile contributes to the favorable tolerability profile that has been observed in clinical trials and pre-clinical studies to date. The FDA has granted Breakthrough Therapy and Fast Track designation to lanifibranor for the treatment of MASH/NASH.
About the NATiV3 Phase III trial
NATiV3 is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the long-term efficacy and safety of lanifibranor (800mg/daily and 1200mg/daily) in adult patients with biopsy-proven non-cirrhotic MASH/NASH and F2/F3 stage of liver fibrosis. The trial takes place in 24 countries and in more than 400 clinical sites and recruits approximately 900 patients to be treated over a 72-week period. The effect of lanifibranor will be assessed on several histological endpoints, including MASH/NASH resolution and improvement of fibrosis of at least one stage. An exploratory cohort is anticipated to enroll approximately 200 patients with MASH/NASH and fibrosis screen-failed on histology for the main NATiV3 clinical trial. Inventiva anticipates that this exploratory cohort may allow the generation of additional data using non-invasive tests and contribute to the regulatory safety database requirement to support the planned submission for potential accelerated approval to the Food and Drug Administration (FDA) and potential conditional approval to the European Medicines Agency (EMA) of lanifibranor for the treatment of MASH/NASH. Topline results of NATiV3 are expected for the second half 2026. For more information about NATiV3, visit clinicaltrials.gov.
About Inventiva
Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with MASH/NASH and other diseases with significant unmet medical need. The Company benefits from a strong expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation. Inventiva is currently advancing one clinical candidate, has a pipeline of two preclinical programs and continues to explore other development opportunities to add to its pipeline.
Inventiva’s lead product candidate, lanifibranor, is currently in a pivotal Phase III clinical trial, NATiV3, for the treatment of adult patients with MASH/NASH, a common and progressive chronic liver disease.
Inventiva’s pipeline also includes odiparcil, a drug candidate for the treatment of adult MPS VI patients. As part of Inventiva’s decision to focus clinical efforts on the development of lanifibranor, it suspended its clinical efforts relating to odiparcil and is reviewing available options with respect to its potential further development. Inventiva is also in the process of selecting a candidate for its Hippo signaling pathway program.
The Company has a scientific team of approximately 90 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, and clinical development. It owns an extensive library of approximately 240,000 pharmacologically relevant molecules, approximately 60% of which are proprietary, as well as a wholly-owned research and development facility.
Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). www.inventivapharma.com
1 Sanyal A et al. NEJM, 362 ; 18, 2010
2 This estimate is based on the Company’s current business plan and excludes any potential milestones payable to or by the Company and any additional expenditures related to the potential continued development of the odiparcil program or resulting from the potential in licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue. The Company may have based this estimate on assumptions that are incorrect and the Company may end up using its resources sooner than anticipated.
3 Short-term deposits are classified as "other current assets" in the consolidated statement of financial position under IFRS and are considered by the Company to be liquid and readily available.
4 The two-year long-term deposit can be accessed before expiry of the term with 31 days' notice and is considered liquid by the Company.
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