• Cash and cash equivalents of €47.3m as at 31 March 2019, in line with expectations
• Revenues increase to €1.0m in Q1 2019 compared to Q1 2018
• Significant progress in NASH, mucopolysaccharidosis type VI (MPS VI) and oncology programs
• New clinical study planned for the treatment of psoriasis with ABBV-157, the drug candidate resulting from the partnership with AbbVie
Lanifibranor in the treatment of systemic sclerosis (“SSc”)
The development of lanifibranor for the treatment of systemic sclerosis was discontinued following the publication in February 2019 of the results of the FASST Phase IIb clinical study, which did not meet its primary endpoint. However, the same study demonstrated that lanifibranor was, in a fragile and poly-medicated population, associated with a favorable safety profile. These good tolerability data reinforce the rationale for developing lanifibranor in NASH. Given the SSc results, the Company is now focusing its resources and its teams on its three priority programs (lanifibranor in NASH, odiparcil in MPS VI and YAP-TEAD in oncology), and on its partnership with Boehringer Ingelheim for the treatment of idiopathic pulmonary fibrosis.
Lanifibranor for the treatment of non-alcoholic steatohepatitis (“NASH”)
In its NATIVE Phase IIb clinical study evaluating lanifibranor in the treatment of NASH, Inventiva randomized its first patient in the US in February 2019. At the end of April 2019, 178 patients out of the 225 patients expected to be enrolled in the study had been randomized, and 96 patients had already completed the six-month study. The NATIVE study is therefore progressing as plannned, and results are expected in the first half of 2020.
The study’s DSMB (Data Safety Monitoring Board) met for the third time in March 2019. After analyzing all the safety data from the study, it recommended — as it did in both previous DSMB meetings — the continuation of the study without changing the protocol, thereby confirming once again lanifibranor’s good safety profile.
Odiparcil for the treatment of mucopolysaccharidoses (“MPS”)
The iMProveS Phase IIa clinical study evaluating odiparcil in the treatment of MPS VI successfully completed its first phase with the first meeting of the DSMB in October 2018. After analysis of the drug candidate’s safety data in MPS VI patients, the DSMB recommended the continuation of the study. Since then, the DSMB met a second time in March 2019 and again recommended the study’s continuation without any modification to the protocol. The study results are expected in the second half of 2019 as planned.
In early March 2019, the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation (RPDD) status to odiparcil. This status confirms odiparcil’s eligibility to obtain a Priority Review Voucher, to be used for another New Drug Application (NDA) or for a Biologics License Application (BLA). These vouchers can reduce the FDA’s review time from 12 to six months. They can be used by the Company or sold or transferred to a third party. Inventiva will receive this voucher once the FDA has granted marketing authorisation to odiparcil.
YAP-TEAD in the field of oncology
The selection of the drug candidate for the YAP-TEAD program in oncology is ongoing and the initiation of its preclinical development is expected to begin this year.
Furthermore, the Company presented new results in the treatment of malignant pleural mesothelioma during the AACR (American Association for Cancer Research) special conference dedicated to the Hippo pathway, held early this month in San Diego, USA. These results showed the potential of Inventiva’s molecules to significantly reduce tumor growth, mitigate drug resistance and restore the sensitivity of chemoresistant cancer cells. Following these promising results, Inventiva decided to expand its research to other cancer indications as well as other combination strategies, where standard of care agents are proven to be ineffective and where YAP activation is involved.
ABBV-157, the drug candidate resulting from the partnership with AbbVie, for the treatment of moderate to severe psoriasis
AbbVie continues the clinical development of ABBV-157, the drug candidate resulting from its collaboration with Inventiva. Following a first Phase I clinical trial, AbbVie recently reported its intention to initiate a new clinical study with ABBV-157, aiming at assessing the compound’s pharmacokinetics, safety and tolerance in healthy volunteers and in patients with chronic plaque psoriasis. This confirms the drug candidate’s potential as well as AbbVie’s determination to develop and commercialize this compound, for which Inventiva could receive milestone payments as well as royalties on future sales. For further information on the new clinical trial, please visit: https://clinicaltrials.gov/ct2/show/NCT03922607
Key milestones expected
• End of recruitment in the NATIVE Phase IIb clinical study evaluating lanifibranor for the treatment of NASH
• End of recruitment in the Phase II clinical study evaluating lanifibranor for the treatment of NAFLD in patients with type 2 diabetes
• End of recruitment in the iMProveS Phase IIa clinical study evaluating odiparcil for the treatment of MPS VI
• Launch of a new biomarker study in patients with MPS VI
• Results of the iMProveS Phase IIa clinical study
• Selection of the preclinical candidate for the YAP-TEAD oncology program
• Launch of a new clinical study with ABBV-157 in healthy volunteers and in patients with chronic plaque psoriasis.
Inventiva is a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of diseases with significant unmet medical needs in the areas of fibrosis, lysosomal storage disorders and oncology.
Leveraging its expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation, Inventiva is currently advancing two clinical candidates – lanifibranor and odiparcil – in non-alcoholic steatohepatitis (“NASH”) and mucopolysaccharidosis (“MPS”), respectively, as well as a deep pipeline of earlier stage programs.
Lanifibranor, its lead product candidate, is being developed for the treatment of patients with NASH, a common and progressive chronic liver disease. Inventiva is currently evaluating lanifibranor in a Phase IIb clinical trial for the treatment of this disease for which there are currently no approved therapies.
Inventiva is also developing odiparcil, a second clinical stage asset, for the treatment of patients with MPS, a group of rare genetic disorders. The Company is currently investigating odiparcil in a Phase IIa clinical trial for the treatment of adult patients with the MPS VI subtype.
In parallel, Inventiva is in the process of selecting an oncology development candidate for its Hippo signaling pathway program and is advancing pre clinical programs for the treatment of autoimmune diseases and idiopathic pulmonary fibrosis (“IPF”) in collaboration with AbbVie and Boehringer Ingelheim respectively. AbbVie is investigating ABBV 157, a clinical development candidate resulting from its collaboration with Inventiva, in a Phase I clinical trial for the treatment of moderate to severe psoriasis. Both collaborations entitle Inventiva to receive milestone payments upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on any approved products resulting from the partnerships.
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. It also owns an extensive library of approximately 240,000 pharmacologically relevant molecules, 60% of which are proprietary, as well as a wholly owned research and development facility.
Inventiva is a public company listed on compartment C of the regulated market of Euronext Paris (Euronext: IVA – ISIN: FR0013233012). http://www.inventivapharma.com
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* ANNOUNCES THAT FDA LIFTS TARGET CLASS CLINICAL HOLD WHICH
ALLOWS LONG-TERM CLINICAL STUDIES WITH LANIFIBRANOR IN NASH
* FDA DECISION BASED ON RESULTS OF CARCINOGENICITY STUDIES
* LANIFIBRANOR DOES NOT SHOW ANY CARCINOGENIC EFFECT
RELEVANT TO HUMANS
* ACHIEVEMENT OF THIS MILESTONE CLEARS KEY OBSTACLE TO PHASE
III CLINICAL DEVELOPMENT OF LANIFIBRANOR IN NASH
Lanifibranor heeft opgeheven. Het besluit stelt Inventiva in staat om voort te gaan met een fase III studie van
Lanifibranor in NASH. De bocht is te danken aan veiligheidsgegevens die de afgelopen 4 jaar werden gegenereerd in
een 1-jarige toxiciteitsstudie bij primaten en twee 2-jarige carcinogeniteitsstudies bij knaagdieren. Koersdoel van 7
euro (bolero.be) en “Kopen”-advies blijven behouden, in afwachting van resultaten van de lopende fase IIb NATIVE studie van
Lanifibranor bij NASH patiënten
- And its gone!
- Forum actieveling
- Berichten: 256
- Lid geworden op: 30 Mei 2018 21:25
- waarderingen: 103
June 11, 2019
Daix (France), June 11, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced the end of patient recruitment for its Phase IIa iMProveS (improve MPS treatment) trial in Europe evaluating odiparcil for the treatment of mucopolysaccharidosis type VI (MPS VI).
A total of 20 patients have been included in this Phase IIa trial versus an initial target of 24. Given odiparcil’s mechanism of action, the Company believes that this number of patients is sufficient to evaluate odiparcil’s safety profile and its impact on relevant efficacy biomarkers (measurement of glycosaminoglycans (GAGs) in the urine, skin and leukocytes) as well as to identify first signs of clinical efficacy in patients receiving enzyme replacement therapy (ERT) and in non-ERT treated patients. Therefore, Inventiva plans to amend the study protocol to update the target patient population to 20 subjects.
The patients included in the trial are distributed among the various arms, with fifteen patients being treated with ERT and receiving one of the two doses of odiparcil or placebo and five patients not being treated with ERT and only receiving the high dose of odiparcil. The headline results of the double-blind placebo controlled arms, which include the fifteen ERT-treated patients, are expected by the end of the year. Results of the open label cohort, which includes the five patients not being treated with ERT and only receiving the high dose of odiparcil, are expected during Q1 2020 given that the last patient for this subgroup was included in May 2019.
Marie-Paule Richard, M.D., Chief Medical Officer of Inventiva, stated: “We are delighted to have achieved this number of very rare disease patients and we are grateful to them and the clinicians participating in this trial. MPS VI is an orphan, and very debilitating disease, with current treatment still leaving patients with high unmet medical needs. Odiparcil has the potential to improve clinical manifestations of the disease, especially in tissues and organs where the efficiency of current treatments is limited. Odiparcil’s oral formulation could also be a great improvement for patients compared to current weekly infusions required for ERT. We look forward to obtaining the results of this Phase IIa trial to evaluate early signals of odiparcil’s efficacy in the treatment of MPS VI and, if positive, to pursue its development.”
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