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GLPG1205 en GLPG1690

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  5. [verwijderd] 15 november 2019 15:13

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    Promedior Enters Into Definitive Merger Agreement To Be Acquired By Roche

    Promedior is a privately held biotechnology company pioneering the development of targeted medicines to treat fibrosis

    Promedior's clinical lead asset PRM-151, a first-in-class recombinant human Pentraxin-2, demonstrated to be the first molecule in idiopathic pulmonary fibrosis (IPF) to show a significant benefit on lung function on top of current therapies

    Total transaction value of up to USD 1.39 billion

    November 15, 2019, 07:30 ET - LEXINGTON, Mass., Nov. 15, 2019 /PRNewswire/ -- Promedior, Inc., today announced that it has entered into a definitive merger agreement for Roche (SIX: RO, ROG;OTCQX: RHHBY) to acquire Promedior. With this acquisition, Roche will obtain full rights to Promedior's entire portfolio of molecules for serious fibrotic diseases, notably PRM-151.

    Promedior, a privately held clinical-stage biotechnology company based in Lexington, Massachusetts, has successfully advanced PRM-151 in human clinical trials and received Breakthrough Therapy Designation from the FDA earlier this year for idiopathic pulmonary fibrosis (IPF). PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein, has demonstrated both prevention and reversal of fibrosis and opens up new opportunities to treat a wide range of systemic fibrotic diseases. Phase 2 trial results demonstrated that PRM-151 is the first molecule to show significant lung function improvements on top of current therapies in IPF. PRM-151 has also shown promising early clinical trial data in myelofibrosis (MF) and its anti-fibrotic mechanism has therapeutic potential in other fibrotic diseases.

    Jason Lettmann, Chief Executive Officer of Promedior and General Partner of Lightstone Ventures, said: "With over a decade of research, development and investment, Promedior has demonstrated the unique ability of its pentraxin-2 platform to deliver disease-modifying potential in fibrotic disorders. Due to Roche's strong expertise in IPF, hematological cancer and other fibrotic disorders, we believe Roche is ideally positioned to bring the potential of our platform to patients and provide new treatment options within these areas of urgent unmet medical need."

    "We are excited to combine Promedior's portfolio with our drug development capabilities to further advance PRM-151 in fibrotic diseases, including IPF and MF," said James Sabry, M.D., Ph.D., global head of Roche Pharma Partnering. "With our proven track record in IPF with Esbriet™ as well as in hematological cancers, we are well-positioned to leverage our clinical and commercial expertise to bring PRM-151 to patients as fast as possible."

    The Pentraxin-2 Platform

    Fibrosis is a common pathway that can affect nearly all tissues and organ systems, including lung, kidney, liver, bone marrow, and the eye. Despite a large unmet medical need, there are few approved, disease-modifying therapies available to treat these systemic fibrotic diseases. Promedior's drug candidates are based on Pentraxin-2 which is an endogenous human protein that is specifically active at the site of tissue damage. PTX-2 works as an agonist that acts as a macrophage polarization factor to initiate a resolution process for prevention and potential reversal of fibrosis, thereby acting as a master regulator upstream in the fibrosis cascade. Extensive studies conducted by Promedior and its collaborators have confirmed this ability of pentraxin-2 therapeutics to act as upstream agonists across many major tissue types and in several models of fibrotic disease, strongly supporting its potential as a novel anti-fibrotic agent.

    Transaction Terms and Approvals

    Under the terms of the merger agreement, Roche will make an upfront cash payment of USD 390 million, plus additional contingent payments of up to USD 1 billion based on the achievement of certain predetermined development, regulatory and commercial milestones.

    The closing of the transaction is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary conditions.

    About PRM-151

    PRM-151, Promedior's lead product candidate, has shown broad anti-fibrotic activity in multiple preclinical models of fibrotic disease, including pulmonary fibrosis, myelofibrosis, acute and chronic nephropathy, liver fibrosis, and age-related macular degeneration. As published in JAMA in 2018, the randomized Phase 2 study in IPF demonstrated that PRM-151 slowed the decline of lung function and stabilized 6-minute walk distance which suggested potential benefit in overall functional decline. The open-label extension data published in Lancet Respiratory Medicine in 2019 further demonstrated evidence of a sustained benefit out to 76 weeks. Positive data from the Phase 2 study in MF highlighted PRM-151's ability to reduce bone marrow fibrosis and was recently presented at the 2019 European Hematology Association Congress.

    About Idiopathic Pulmonary Fibrosis (IPF)

    Idiopathic pulmonary fibrosis (IPF) is a progressive, irreversible and ultimately fatal disease characterized by progressive loss of lung function due to fibrosis (scarring) in the lungs, which hinders the ability of lungs to absorb oxygen. IPF inevitably causes shortness of breath, and a deterioration in lung function and exercise tolerance. IPF patients follow different and unpredictable clinical courses and it is not possible to predict if a patient will progress slowly or rapidly, or when the rate of decline may change. Current therapies slow the decline in FVC but are limited in their ability to improve function or halt disease progression. The median survival time from diagnosis is two to three years which makes IPF more rapidly lethal than many malignancies, including breast, ovarian and colorectal cancers.

    About Myelofibrosis (MF)

    Myelofibrosis (MF), a type of myeloproliferative neoplasm, is a serious, life-limiting cancer that is characterized by fibrosis of the bone marrow. Replacement of the bone marrow by scar tissue prevents the normal production of blood cells, leading to anemia, fatigue, and increased risk of bleeding and infection. Production of blood cells shifts to the spleen and liver (extramedullary hematopoiesis), which become enlarged, causing severe discomfort, inability to eat, and weakness. The only potentially curative treatment is allogeneic bone marrow transplant while other currently available therapies address the symptoms but have minimal if any impact on the underlying fibrosis.

    About Promedior

    Promedior is a clinical stage biotechnology company pioneering the development of targeted therapeutics to treat diseases involving fibrosis. Promedior has successfully advanced its lead therapeutic candidate in human clinical trials and is initially focused on rare fibrotic diseases, including idiopathic pulmonary fibrosis and myelofibrosis. Promedior is backed by leading global healthcare venture investors including Morgenthaler Ventures, HealthCare Ventures, Forbion, Easton Capital, Fibrotec Ventures, and Polaris Partners and has a significant intellectual property estate relating to the discoveries and applications of pentraxin-2 therapeutics.

    www.prnewswire.com/news-releases/prom...
  6. [verwijderd] 15 november 2019 15:15

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    De kaarten zijn geschud: Roche koopt Promedior, Boehringer heeft een overeenkomst met Bridge. Galapagos ligt voor, maar de aangekondigde vertraging gisteren is een kleine tegenvaller.

    fc
  7. winx09 15 november 2019 17:18

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    Ik heb geen tegenvaller vernomen gisteren. Ja de futil gaat van 2h20 naar 1q21. Maar ondertussen zijn meer dan 33% van de patiënten geworven en is de verwachting dat volgend jaar om deze tijd de trial volledig gerecruiteerd is.

    Gister wel wat gegoochel met cijfers (25% werd 30% en toen 28%) en verbazingwekkend niets over de 70% "eis" (3q19 webcast).

    Mooi als Isabella nov20 vol zit, en wie weet wat de DMC gaat roepen in 1q21 (mag je niet op speculeren, maar met 28% van de patiënten op vol jaar en 70% van de complete data set aanwezig, zou het best onethisch kunnen blijken te zijn om met de placebo groep door te gaan).

  8. MtBaker 22 november 2019 00:18

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    directeur fibrosis ipf en pillentest mogelijk indicatie van versnelde torlating is bij mij als theorie ontstaan.
  14. [verwijderd] 28 november 2019 20:16

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    quote:

    sanderus_1 schreef op 28 november 2019 19:09:

    ZIRITAXESTAT blijkt de commerciële
    naam te worden van glpg1690.

    pubchem.ncbi.nlm.nih.gov/compound/Zir...

    Even los van de eerdere bekendheid van de naam ziritaxestat, wordt dit m.i. ook niet de commerciële naam, maar de generieke, niet-commerciële, wetenschappelijke naam. Net als dat filgotinib straks ook niet de commerciële naam wordt van GlPG634, en er een nieuwe, commerciële naam komt. De niet-commerciële namen staan bekend als International nonproprietary name, INN. Ze worden gebruikt om verwarring te voorkomen, bijvoorbeeld als één stof onder verschillende commerciële namen verkocht wordt.
    Zie ook:
    en.wikipedia.org/wiki/International_n...

    En specifieker over de naamgeving van ziritaxestat:
    www.who.int/medicines/services/inn/Pr...

    -stat slaat op enzymes inhibitors. In bovenstaand pdf document worden drie voorbeelden gegeven (pagina 5):

    -stat-/-stat enzymes inhibitors
    -becestat beta secretase inhibitors
    -demstat histone lysine specific demethylase inhibitors
    -metostat histone N-methyltransferases inhibitors

    De TAXE uit ziritaxestat komt ongetwijfeld van autoTAXin.
    De ziri is dan een 'willekeurige' toevoeging om 1690 uniek te maken.
    Een andere autotaxin inhibitor van een andere biotech zou dan bv. opotaxestat gaan heten.

    De naam ziritaxestat verandert ook niet meer, er komt straks (bij goedkeuring) wel een commerciële naam bij. De generieke naam zal naast de commerciële naam gebruikt blijven worden, in het medisch circuit en door apotheken.
  16. [verwijderd] 5 december 2019 22:12

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    Mechelen, Belgium; 5 December 2019, 22.01 CET – Galapagos NV (Euronext & NASDAQ: GLPG) has completed recruitment for the NOVESA Phase 2 clinical trial with GLPG1690.


    NOVESA is a double-blind, placebo-controlled Phase 2a trial evaluating the efficacy, safety and PK/PD of GLPG1690 in patients with systemic sclerosis (SSc), an autoimmune disease involving multiorgan fibrosis which has one of the highest mortality rates among rheumatic diseases1. NOVESA recruited 33 patients with diffuse cutaneous systemic sclerosis (dcSSc). One of the most visible manifestations is hardening of the skin. In dcSSc, the skin thickening is more widespread; these patients have a higher risk of developing fibrosis of multiple internal organs, including the lung. There are no approved drugs for this disease. SSc affects approximately 124,000 patients2 in the US and Europe3, with a predominance of female patients (>80%).

    The primary endpoint of NOVESA is the modified Rodnan Skin Score (mRSS) at 24 weeks. mRSS measures the skin thickness as a surrogate measure of disease severity and mortality in those with dcSSc. An increase in skin thickness is associated with involvement of internal organs and increased mortality4. Secondary and exploratory parameters include FVC5, HRCT6, safety and tolerability, quality of life as measured by QoL-Q (SHAQ)7, and CRISS8, a SSc disease composite score. Topline results from the NOVESA trial are expected in the second half of 2020. Patients completing the NOVESA study are offered the opportunity to roll over to a long-term extension trial.

    “We are excited by the rapid enrollment into NOVESA and look forward to learning the results of GLPG1690’s efficacy and safety in patients with SSc. We consider SSc as an important and complementary indication to idiopathic pulmonary fibrosis, where a global Phase 3 program is underway,” said Dr Walid Abi-Saab, Chief Medical Officer of Galapagos. “Thanks to the broad mechanism of action of ‘1690, which we believe is both anti-inflammatory and anti-fibrotic, this compound has the potential to address the important unmet medical need in SSc.”
  17. [verwijderd] 5 december 2019 22:20

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    quote:

    maxen schreef op 5 december 2019 22:12:

    ...
    “We are excited by the rapid enrollment into NOVESA and look forward to learning the results of GLPG1690’s efficacy and safety in patients with SSc. We consider SSc as an important and complementary indication to idiopathic pulmonary fibrosis, where a global Phase 3 program is underway,” said Dr Walid Abi-Saab, Chief Medical Officer of Galapagos. “Thanks to the broad mechanism of action of ‘1690, which we believe is both anti-inflammatory and anti-fibrotic, this compound has the potential to address the important unmet medical need in SSc.”
    Dus de uitslag van deze trial zal ook een indicatie geven over de werkzaamheid van 1690 bij IPF. En de uitslag van NOVESA komt eerder dan de eerste tip van de sluier van 1690 in IPF:

    Topline results from the NOVESA trial are expected in the second half of 2020, wordt in dit PB gezegd. Terwijl de uitslag van de futility analyse van 1690 in IPF nu verwacht wordt in H1 2021.

    Er zal dus heel veel belang gehecht gaan worden aan de uitslag van NOVESA in H2 2020, daar die gekoppeld gaat worden aan de verwachtingen over de IPF phase 3 trial.
  19. forum rang 10 voda 8 december 2019 08:56

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    Diffuse cutaneous systemic sclerosis

    Other Names: Diffuse cutaneous systemic sclerosis; DcSSc; Progressive cutaneous systemic scleroderma; See More
    Categories: Heart Diseases; Kidney and Urinary Diseases; Lung Diseases; See More
    This disease is grouped under: Systemic scleroderma

    Voor meer, zie link:

    rarediseases.info.nih.gov/diseases/97...
  20. [verwijderd] 13 december 2019 14:17

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    Novesa studie :
    A Phase 2a Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered GLPG1690 for 24 Weeks in Subjects With Systemic Sclerosis

    Gisteren, 12/12/2019, van Recruiting op "Active, not recruiting" gezet.
    Estimated Primary Completion : May 2020
    Estimated Study Completion : August 2020

    Dat wordt nog een interessant nieuwtje, volgend jaar.

    clinicaltrials.gov/ct2/history/NCT037...
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