A Phase 3, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease

The purpose of study is to test the effect of an experimental medication GED-0301(mongersen) and evaluate its safety in patients (≥ 12 years of age) with active Crohn's disease. The study will test GED-0301 compare to placebo for 12 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease. Adolescent patients will also be allowed treatment with stable doses of exclusive enteral nutrition and growth hormone.
All patients who complete the study will have the option to enter a long term active treatment study.

Start Date01 Dec 2017

Sponsor / Collaborator

Celgene Corp.

EUCTR2015-001924-40-HR / Not yet recruitingPhase 3

A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease

Start Date13 Oct 2017

Sponsor / Collaborator

Celgene Corp.

EUCTR2015-001924-40-IT / Not yet recruitingPhase 3

Start Date12 Jun 2017

Sponsor / Collaborator

Celgene Corp.

100 Clinical Results associated with Mongersen

100 Translational Medicine associated with Mongersen

100 Patents (Medical) associated with Mongersen

Literatures (Medical) associated with Mongersen

01 Nov 2023·European Journal of Immunology

TGF‐β1 signaling and Smad7 control T‐cell responses in health and immune‐mediated disorders

Review

Author: Monteleone, Giovanni ; Laudisi, Federica ; Stolfi, Carmine ; Monteleone, Ivan

AbstractTransforming growth factor (TGF)‐β1, a member of the TGF‐β superfamily, is produced by many immune and nonimmune cells and has pleiotropic effects on both innate and adaptive immunity, especially in the control of T‐cell differentiation and function. Consistently, loss of TGF‐β1 function is associated with exacerbated T‐cell‐dependent inflammatory responses that culminate in pathological processes in allergic and immune‐mediated diseases. In this review, we highlight the roles of TGF‐β1 in immunity, focusing mainly on its ability to promote differentiation of regulatory T cells, T helper (Th)‐17, and Th9 cells, thus contributing to amplifying or restricting T‐cell responses in health and human diseases (e.g., inflammatory bowel diseases, type 1 diabetes, asthma, and MS). In addition, we discuss the involvement of Smad7, an inhibitor of TGF‐β1 signaling, in immune‐mediated disorders (e.g., psoriasis, rheumatoid arthritis, MS, and inflammatory bowel diseases), as well as the discordant results of clinical trials with mongersen, an oral pharmaceutical compound containing a Smad7 antisense oligonucleotide, in patients with Crohn's disease. Further work is needed to ascertain the reasons for such a discrepancy as well as to identify better candidates for treatment with Smad7 inhibitors.

01 Dec 2022·Die UnfallchirurgieQ4 · MEDICINE

Schwerverletztenversorgung durch Notärzte aus unterschiedlichen Fachgebieten

Q4 · MEDICINE

Article

Author: Wafaisade, Arasch ; Ruppert, Matthias ; Gäßler, Michael ; Lefering, Rolf ; Bouillon, Bertil

01 Sep 2022·Molecular Diagnosis & Therapy

Smad7 Antisense Oligonucleotide-Based Therapy in Crohn's Disease: Is it Time to Re-Evaluate?

Article

Author: Monteleone, Giovanni ; Stolfi, Carmine ; Neurath, Markus F ; Atreya, Raja ; Marafini, Irene

Abundant preclinical work showed that in Crohn's disease (CD), the defective activity of the immunosuppressive cytokine tumor necrosis factor (TGF)-β1 due to high levels of the intracellular inhibitor Smad7 contributes to amplify the tissue-damaging inflammatory response. Consistently, phase I and II studies documented clinical and endoscopic benefit in active CD patients treated with mongersen, an oral antisense oligonucleotide targeting Smad7. However, a multicenter, randomized, double-blind, placebo-controlled, phase III study was prematurely discontinued as a futility analysis showed that mongersen was not effective in CD patients. The reasons why the phase III study failed despite the fact that previous clinical trials documented the efficacy of the drug remain unknown. The primary objective of this Viewpoint was to provide clues about the factors explaining discrepancies among the clinical trials. We illustrate the recent data indicating that the various batches of mongersen, used during the phase III program, are chemically different, with some of them being unable to downregulate Smad7 expression. Overall, these findings suggest the necessity of new clinical studies to further evaluate the efficacy of chemically homogenous batches of mongersen in patients with inflammatory bowel diseases (IBDs), and, at the same time, they can help understand the failure of other clinical trials with antisense oligonucleotides in IBD (i.e. alicaforsen).

News (Medical) associated with Mongersen

28 Jun 2022

·www.prnewswire.com

Bulletin from the Annual General Meeting in Oncopeptides AB (publ)

STOCKHOLM, June 28, 2022 /PRNewswire/ -- The Annual General Meeting in Oncopeptides AB (publ) (ONCO) was held on Tuesday, 28 June 2022. At the Annual General Meeting, the following principal resolutions were passed. The presented annual report was adopted, and the members of the Board of Directors and the CEOs were discharged from liability in respect of the financial year 2021. It was resolved to carry forward the result for the year in accordance with the Board of Directors' proposal. The proposed remunerations to the Board of Directors, the Board of Directors' committees and the Company's auditor were approved. Per Wold-Olsen, Brian Stuglik, Cecilia Daun Wennborg, Jarl Ulf Jungnelius, Per Samuelsson and Jennifer Jackson were re-elected as board members. Per Wold-Olsen was also re-elected as Chairman of the Board of Directors. Ernst & Young AB was re-elected auditor of the company, with the request for Anna Svanberg as auditor in charge. It was resolved to approve the Board of Directors' proposal regarding remuneration report. It was resolved to adopt the proposed new articles of association. It was resolved, in accordance with the Nomination Committees proposal, to introduce a long-term shareholder program for members of the Board of Directors ("Board SHP 2022"). The program is share based and intended for main owner independent members of the Board of Directors. Board SHP 2022 is a program under which the participants will be granted share awards ("Share Awards") that entitle to not more than 245,000 ordinary shares in Oncopeptides. The number of share awards that shall be awarded to each participant shall correspond to 50 per cent of the remuneration for ordinary board work, for the respective participant divided by the volume weighted average price of the Oncopeptides share on Nasdaq Stockholm for the 10 trading days preceding the grant date. The number of share awards shall correspond to a certain amount (SEK 750,000 to the Chairman and SEK 300,000 to each of the other main owner independent members of the Board of Directors). The Share Awards shall be granted to the participants as soon as practicable after the Annual General Meeting (the "Grant Date"). The Share Awards shall vest after approximately one year (corresponding to one year of service as a Board member), corresponding to the earlier of the day before (i) the Annual General Meeting 2023 or (ii) 1 July 2023 (the "Vesting Date"), provided that the participant is still a Board member of Oncopeptides on said date. Each vested share award entitles the holder to receive one share in the Company without any compensation being payable as soon as practicable three years after the Grant Date. It was further resolved, in accordance with the Nomination Committees proposal to authorize the Board of Directors to resolve on a directed share issue of class C shares, authorize the Board of Directors to repurchase issued class C shares and transfer of own ordinary shares. It was resolved, in accordance with the Board of Directors' proposal, to introduce a long-term performance based incentive program for the Company´s employees and consultants ("Co-worker LTIP 2022"). The program is share based and intended for the Company´s employees and consultants. Co-worker LTIP 2022 is a program under which the participants will be granted, free of charge, share awards subject to performance vesting ("Share Awards") that entitle to not more than 3,860,849 ordinary shares in Oncopeptides. The number of share awards that shall be awarded to each participant shall correspond to the yearly allocation (which is a percentage of the base salary) divided by the volume weighted average price of Oncopeptides´ share on Nasdaq Stockholm for the 10 trading days preceding the grant date. The share awards are subject to performance vesting based on the development of the price of the Company's share over the period from the date the Share Awards are allocated ("Grant Date") up to and including the third anniversary of the Grant Date (the "Vesting Date"). Each vested share award entitles the holder to receive one share in the Company without any compensation being payable provided that the holder is still an employee of Oncopeptides at the relevant times of vesting. It was further resolved, in accordance with the Board of Directors' proposal, to authorize the Board of Directors to resolve on a directed share issue of class C shares, authorize the Board of Directors to repurchase issued class C shares and transfer of own ordinary shares. It was resolved, in accordance with the Board of Directors' proposal, to authorize the Board of Directors to, until the next Annual General Meeting, on one or more occasions, decide upon issuances of new shares, issuance of warrants and/or convertibles. New issues of shares and issues of warrants and/or convertibles may occur with or without preferential rights for shareholders of the Company and may be made either in cash and/or by way of set-off or contribution in kind or otherwise on terms. The purpose of the authorization is to increase the financial flexibility of the company and the acting scope of the board of directors. Should the board of directors resolve on an issue with deviation from the shareholders' preferential rights, the reason for this must be to finance an acquisition of operations or, alternatively, to procure capital to finance project development. The number of shares issued under the authorization, or the number of shares created in connection with exercise of warrants or conversion of convertibles, may not correspond to a dilution of more than 20 per cent of the total number of shares outstanding at the Annual General Meeting's resolution on the proposed authorization, after full exercise of the authorization. It was resolved to adopt the proposed updated guidelines for remuneration to the senior management. For further information, please contact: Rolf Gulliksen, Global Head of Corporate Communications, Oncopeptides AB (publ) E-post: [email protected] Mobil: + 46 70 262 96 28 The above information was released for public disclosure on 28 June 2022 at 14:00 (CEST). About Oncopeptides Oncopeptides is a biotech company focused on research and development of pharmaceuticals for difficult-to-treat haematological diseases. The company uses its proprietary PDC platform to develop peptide-drug conjugated compounds that rapidly and selectively deliver cytotoxic agents into cancer cells. The first drug coming from the PDC platform, Pepaxto® (INN melphalan flufenamide), was granted accelerated approval in the U.S., on February 26, 2021, in combination with dexamethasone, for treatment of adult patients with relapsed or refractory multiple myeloma. Due to regulatory hurdles the product is currently not marketed in the U.S. On June 23, 2022, CHMP adopted a positive opinion recommending full approval of Oncopeptides Pepaxti® (melphalan flufenamide), in EU in patients with triple class refractory multiple myeloma. Oncopeptides is developing several new compounds based on the PDC platform. The company is listed in the Mid Cap segment on Nasdaq Stockholm with the ticker ONCO. More information is available on . This information was brought to you by Cision The following files are available for download: SOURCE Oncopeptides AB

Accelerated ApprovalAcquisition

30 Apr 2018

·www.globenewswire.com

The Klein Law Firm Announces a Class Action Filed on Behalf of Celgene Corporation Shareholders and a Lead Plaintiff Deadline of May 29, 2018 (CELG)

NEW YORK, April 30, 2018 (GLOBE NEWSWIRE) -- The Klein Law Firm announces that a class action complaint has been filed on behalf of shareholders of Celgene Corporation (NASDAQ:CELG) who purchased shares between September 12, 2016 and February 27, 2018. The action, which was filed in the United States District Court for the District of New Jersey, alleges that the Company violated federal securities laws. In particular, the complaint alleges that throughout the Class Period, defendants made materially false and/or misleading statements and/or failed to disclose that (1) the trials for GED-0301 suffered from fatal design defects, such that GED-0301 had failed to demonstrate meaningful clinical efficacy; (2) the growth of Otezla sales had dramatically slowed during Celgene's third fiscal quarter of 2017; and (3) the clinical and nonclinical pharmacology data in Celgene's new drug application ("NDA") for Ozanimod were insufficient to permit a complete review by the FDA, which resulted in the FDA issuing a refusal to file letter to Celgene regarding the NDA. Shareholders have until May 29, 2018 to petition the court for lead plaintiff status. Your ability to share in any recovery does not require that you serve as lead plaintiff. You may choose to be an absent class member. If you suffered a loss during the class period and wish to obtain additional information, please contact Joseph Klein, Esq. by telephone at 212-616-4899 or visit http://www.kleinstocklaw.com/pslra-c/celgene-corporation?wire=3. Joseph Klein, Esq. represents investors and participates in securities litigations involving financial fraud throughout the nation. Attorney advertising. Prior results do not guarantee similar outcomes. CONTACT:Joseph Klein, Esq.Empire State Building350 Fifth Avenue59th FloorNew York, NY 10118Telephone: (212) 616-4899Fax: (347) 558-9665www.kleinstocklaw.com

23 Apr 2018

·www.globenewswire.com

CELG SHAREHOLDER ALERT: The Law Offices of Vincent Wong Notifies Investors of Commencement of a Class Action Involving Celgene Corporation and a Lead Plaintiff Deadline of May 29, 2018

NEW YORK, April 23, 2018 (GLOBE NEWSWIRE) -- The Law Offices of Vincent Wong announce that a class action lawsuit has been commenced in the United States District Court for the District of New Jersey on behalf of investors who purchased Celgene Corporation ("Celgene") (NASDAQ:CELG) securities between September 12, 2016 and February 27, 2018 . Click here to learn about the case: http://www.wongesq.com/pslra-c/celgene-corporation?wire=3 . There is no cost or obligation to you. According to the complaint, throughout the Class Period, the Company issued materially false and misleading statements and/or failed to disclose that: (1) the trials for GED-0301 suffered from fatal design defects, such that GED-0301 had failed to demonstrate meaningful clinical efficacy; (3) the growth of Otezla sales had dramatically slowed during Celgene's third fiscal quarter of 2017; and (4) the clinical and nonclinical pharmacology data in Celgene's new drug application ("NDA") for Ozanimod were insufficient to permit a complete review by the FDA, which resulted in the FDA issuing a refusal to file letter to Celgene regarding the NDA. If you suffered a loss in Celgene you have until May 29, 2018 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn’t require that you serve as a lead plaintiff. To obtain additional information, contact Vincent Wong, Esq. either via email vw@wongesq.com , by telephone at 212.425.1140, or visit http://www.wongesq.com/pslra-c/celgene-corporation?wire=3 . Vincent Wong, Esq. is an experienced attorney that has represented investors in securities litigations involving financial fraud and violations of shareholder rights. Attorney advertising. Prior results do not guarantee similar outcomes. CONTACT: Vincent Wong, Esq. 39 East Broadway Suite 304 New York, NY 10002 Tel. 212.425.1140 Fax. 866.699.3880 E-Mail: vw@wongesq.com

100 Deals associated with Mongersen

External Link

KEGG	Wiki	ATC	Drug Bank
D10956	-	-	DB15019

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Crohn Disease	Preclinical	DK	Celgene Corp.	08 Dec 2015
Crohn Disease	Preclinical	IL	Celgene Corp.	08 Dec 2015
Crohn Disease	Preclinical	MY	Celgene Corp.	08 Dec 2015
Crohn Disease	Preclinical	FI	Celgene Corp.	08 Dec 2015
Crohn Disease	Preclinical	CH	Celgene Corp.	08 Dec 2015
Crohn Disease	Preclinical	TR	Celgene Corp.	08 Dec 2015
Crohn Disease	Preclinical	BG	Celgene Corp.	08 Dec 2015
Crohn Disease	Preclinical	HU	Celgene Corp.	08 Dec 2015
Crohn Disease	Preclinical	CA	Celgene Corp.	08 Dec 2015
Crohn Disease	Preclinical	UA	Celgene Corp.	08 Dec 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02685683 (Pubmed \| BioDrugs) Manual	Phase 2	Crohn Disease	18	Mongersen	(mjwpwtdigb) = vqgxgcwdvn jtgugpfyqp (aashrqwvzx ) View more	Positive	01 May 2021
NCT02596893 (Pubmed \| Am J Gastroenterol)	Phase 3	Crohn Disease	701	Placebo	(mlnekfzwwc) = lftkhhzjdw xswzrfhjee (bwscklsrde ) View more	Negative	01 May 2020
				GED-0301 160 mg for 12 weeks followed by 40 mg continuously	(mlnekfzwwc) = nfcskqbigz xswzrfhjee (bwscklsrde ) View more
NCT02641392 (CTgov)	Phase 3	Crohn Disease	310	placebo+GED-0301 (GED 40 mg 4 Weeks Alt)	vygczdbarq(rhghdvzggk) = ccyzwzeknc tsmcehnntw (cdbszuvttv, nwzjwrruof - wwvncuveay) View more	-	29 Jan 2019
				GED-0301 (GED-0301 40 mg)	vygczdbarq(rhghdvzggk) = kjizjiftaq tsmcehnntw (cdbszuvttv, lfgbveucmi - dpdaqcbsru) View more
NCT02596893 (CTgov)	Phase 3	Crohn Disease	701	Placebo	mtkmhwqokh(ihhduhzrvw) = qjfvldsxfs jbewspifkf (wzazxdubib, mjwfzmlada - csstmnwqyv) View more	-	23 Jan 2019
NCT02601300 (CTgov)	Phase 2	Colitis, Ulcerative	41	Mongersen (Mongersen (Weeks 0-52))	xgqbisghyl(gatkzlpneu) = qlxhzwpxit gfspnhngde (ghcqglsiqe, hssbziwijp - sgifpwlabo) View more	-	12 Sep 2018
				mongersen (Mongersen Total Mongersen Exposure Period)	uedujpoflk(oktptzpbki) = vjvialxcau mpsuqqyzbf (hfkddsltki, mkcovrvyke - kxspmklbqn) View more
NCT02367183 (Pubmed \| J Laparoendosc Adv Surg Tech A)	Phase 1	Crohn Disease	63	GED-0301 4-week treatment	(eefttrrxuy) = hcqwdjxsqz jnjgnwrlkn (ctszrvhbrf ) View more	-	01 Jan 2018
				GED-0301 8-week treatment	(eefttrrxuy) = hxrqdfhaox jnjgnwrlkn (ctszrvhbrf ) View more
UEGW	Not Applicable	Crohn Disease	-	Mongersen 10 mg/day	kiercclmwn(jontuhahox) = The rates of adverse events (AEs) and serious AEs (SAEs) were similar across groups. Nine SAEs occurred in 6 patients (placebo, n=1; Mongersen 10 mg, n=3; 40 mg, n=1; 160 mg, n=1). Most SAEs consisted of hospital admissions for CD-associated complications or symptoms, and included: pyrexia and cough (placebo); abdominal pain (n=2), CD worsening and pyrexia (Mongersen 10 mg); seton placement for perianal fistula and surgery for hemorrhoid thrombosis (Mongersen 40 mg); and thermal burn (Mongersen 160 mg) vnryhuwsbi (vcjcvqoluz )	-	01 Oct 2014
				Mongersen 40 mg/day

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