Q1 2019 Financial Information and Corporate Business Update

World News: . []

              – 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 reported its cash position and revenues for the first quarter 2019, and provided a corporate business update.

As at 31 March 2019, Inventiva’s were €47.3 million, vs. €56.7 million on 31 December 2018, in line with the Company’s expectations. Inventiva’s cash burn was primarily driven by its ongoing preclinical and clinical studies.

Net cash flow amounted to -€9.4 million in the first quarter of 2019, including -€8.6 million from operating activities (vs. -€7.7 million in the first quarter of 2018). R&D expenses for the quarter, mainly driven by lanifibranor and odiparcil programs, were up 34.4% compared to the first quarter of 2018.

The Company’s for the first quarter of 2019 increased to €1.0 million from €0.5 million in the first quarter of 2018.

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.

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.

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.

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.

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:

            

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).

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Globe Newswire: 16:45 GMT Wednesday 15th May 2019

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