A Randomized, Active-controlled, Patient and Investigator-masked, Multiple Dose Proof-of-concept Study of Intravitreal LKA651 in Patients With Diabetic Macular Edema

The primary objectives of this study were to evaluate the safety and efficacy of LKA651 in patients with macular edema from diabetic macular edema (DME),

Start Date24 May 2019

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT02867735 / CompletedPhase 1

A Randomized, Single-masked, Sham-control, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema From Diabetic Macular Edema (DME), Neovascular Age-related Macular Degeneration (AMD), or Retinal Vein Occlusions (RVO)

To evaluate the safety and tolerability of LKA651 in patients with macular edema from diabetic macular edema (DME), neovascular age-related macular degeneration (AMD), or retinal vein occlusions (RVO)

Start Date21 Sep 2016

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT02281292 / WithdrawnPhase 1

A Randomized, Sham Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Diabetic Macular Edema

The purpose of this study is to evaluate the initial safety of intravitreal (IVT) LKA651 and potential for use alone or in combination with Ranibizumab ophthalmic solution (Lucentis®) for the treatment of Diabetic Macular Edema (DME) in patients with symptomatic disease.

Start Date01 Dec 2015

Sponsor / Collaborator

Alcon Research Ltd.

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100 Clinical Results associated with LKA-651

100 Translational Medicine associated with LKA-651

100 Patents (Medical) associated with LKA-651

News (Medical) associated with LKA-651

25 Apr 2023

·www.fiercebiotech.com

Novartis prunes assets, axing 10% of pipeline programs to narrow R&D focus

The number of projects in Novartis’ pipeline fell from 150 to 134. Novartis has undertaken an old-fashioned decimation of its pipeline. The Swiss drugmaker has decided to dump or out-license 10% of its R&D projects to narrow its sights on five core therapeutic areas and focus investment on its most promising programs within those spaces. In recent quarters, Novartis has decided to make five therapeutic areas—cardiovascular, hematology, solid tumors, immunology and neuroscience—and a small clutch of technology platforms the focus of its R&D activities. More recently, disclosures about partnered programs that Novartis is dumping gave hints that an overhaul was underway. Now, Novartis has shared a full look at its slimmed-down pipeline. “We reduced our pipeline size by about 10%. And that's primarily as we prune assets that are outside of those five core therapeutic areas, or in the sixth area we call TAX which incubate certain therapeutic areas we're interested in,” Novartis CEO Vas Narasimhan, M.D., said on an early morning call with the media. “So we've taken the principal decision that if it doesn't fit within that framework, we are either going to stop the programs or divest them.” Expanding on the decision in a later call with analysts, Narasimhan explained that part of the pipeline “cleanup” had been the result of benchmarking Novartis’ R&D against its fellow Big Pharmas. “We had more projects than our peers, which led us to have less investment per project versus the peer set,” the CEO explained. “We think that's important because in having strong investment in the early stage pre-clinically or in early clinical can also help us go faster, go broader into more lines of therapy, more indications.” As a result of the changes, the number of projects in Novartis’ pipeline has fallen from 150 to 134. Solid tumors, an ongoing area of focus, took the biggest hit, with the number of active projects falling from 42 to 32 between the two updates. Addressing the significant reduction in early-stage cancer assets, Narasimhan told analysts that Novartis had removed candidates with targets that “are no longer priority tumors for the company.” Below, we provide an overview of the programs that Novartis dropped from its pipeline in its quarterly pipeline update. But before getting to that, there is one candidate clinging on that is nonetheless worth discussing. In the fourth quarter, Novartis listed six studies involving spartalizumab, an anti-PD-1 checkpoint inhibitor that failed a phase 3 melanoma trial in 2020. Today, only one study remains. Phase 2 ADPT06: A cognitive impairment candidate that Novartis tested in a phase 2 platform clinical trial of various anti-inflammatory agents. The mechanism of action is unknown. Novartis tested canakinumab, sold in other indications as Ilaris, in the same trial of patients with mild cognitive impairment due to Alzheimer's disease. HSY244: An atrial fibrillation candidate that Novartis took into phase 2 in 2020. Novartis “prematurely ended” the study, per the European database, but ClinicalTrials.gov still lists it as recruiting patients. Ensovibep: The COVID-19 antiviral that Novartis bought at the start of last year for 150 million Swiss francs ($168 million). Within months, Novartis’ plan to bring the molecule to market unraveled as the FDA requested phase 3 data. Novartis licensed the asset from Molecular Partners. LKA651: A MorphoSys-partnered EPO inhibitor that Novartis studied in diabetic macular edema. Novartis completed a phase 2 clinical trial of the drug candidate last summer. Phase 1 FIA586: The final domino to fall in Novartis’ exit from nonalcoholic steatohepatitis (NASH). The Swiss drugmaker wrapped up an early-phase trial of the candidate in mild and moderate hepatic impairment last summer. MHS552: An autoimmune disease candidate that Novartis was studying in a phase 1 lupus trial when it decided to pull the plug. The company filed to test the molecule in type 1 diabetes but withdrew the study before enrolling any patients. ADPT03: A BCL11A program targeting sickle cell disease. Intellia disclosed that Novartis had stopped work on an ex vivo, CRISPR-edited cell therapy designed to reduce the activity of BCL11A earlier this year. JEZ567: A anti-CD123 CAR-T cell therapy that Novartis was developing in acute myeloid leukemia. MAK683: An inhibitor of embryonic ectoderm development protein that Novartis has studied in people with diffuse large B-cell lymphoma since 2016. WVT078: A BCMAxCD3 bispecific antibody that Novartis studied in multiple myeloma. The presence of many other BCMA candidates at other companies makes WVT078 a poor fit for Novartis’ focus on “high value medicines with transformative potential for patients.”

Phase 2Cell TherapyPhase 1ImmunotherapyClinical Result

12 May 2021

·www.globenewswire.com

Diabetic Macular Edema Pipeline Sees Expansion Owing to Key

Los Angeles, USA, May 12, 2021 (GLOBE NEWSWIRE) -- Diabetic Macular Edema Pipeline Sees Expansion Owing to Key Players, Key Therapies and Research & Programmes Diabetic Macular Edema Pipeline Insight report offers deep insights into emerging Diabetic Macular Edema pipeline therapies with an analysis of 50+key players and 50+key therapies. DelveInsight’s ‘Diabetic Macular Edema (DME) Pipeline Insights’ report provides a holistic view of the DME pipeline therapies that are under development in pre-clinical as well as clinical stages of development and growth prospects across the Diabetic Macular Edema landscape. Key takeaways of the Diabetic Macular Edema Pipeline report: Got queries? Want to know more? Request for Sample @ Diabetic Macular Edema Emerging Therapies and Forecast Diabetic Macular Edema: Overview Macular edema is a condition characterized by the build-up of fluid in the macula, an area in the center of the retina. The excess build-up results in the swelling and thickening of the macula leading to distorted vision. It is referred to as Diabetic Macular Edema (DME) as it is caused by a complication of diabetes called diabetic retinopathy. For more information on emerging drugs, visit Diabetic Macular Edema Pipeline Analysis The DME pipeline report proffers a rich coverage of the therapeutics by development stage, product type, and route of administration, molecule type, and MOA type for Diabetic Macular Edema across the complete product development cycle, including all clinical and non-clinical stages. Diabetic Macular Edema Pipeline Drugs Request for Sample to know which drug is expected to outperform @ Diabetic Macular Edema Pipeline Analysis, Key Companies, and Futuristic Trends Diabetic Macular Edema Therapeutics Assessment The Diabetic Macular Edema Pipeline report proffers exhaustive insights into active pipeline assets segmented by Stage, Product Type, Route of Administration, Molecule Type, Target, and Indications of various drugs. By Product Type By Stage By Molecule Type By Route of Administration By Mechanism of Action By Targets By Stage and Route of AdministrationBy Stage and Product Type Get in touch with our Business executive for Rich and Deep Market Assessment and Consulting Solutions The Diabetic Macular Edema pipeline report puts on the table business opportunities, threats, prospective collaborations, strong competitors, growth strategies, and failed as well as discontinued drugs that will help the clients to keep a track of the ongoing trials, recent happenings in the DME domain. Scope of the Report Coverage: GlobalKey Players: Kodiak Sciences, Novartis Pharmaceuticals, Adverum Biotechnologies, KalVista Pharmaceuticals, Momenta Pharmaceuticals, Roche, Regeneron Pharmaceuticals, Exonate, Opthea Limited, SciFluor Life Sciences, AsclepiX Therapeutics, RemeGen, UNITY Biotechnology, Celltrion, Bio-Thera Solutions, Ripple Therapeutics, GrayBug Vision, Oxurion, Aerie Pharmaceuticals, GlaxoSmithKline, Boehringer Ingelheim, and Apexian Pharmaceuticals among others.Key Diabetic Macular Edema Pipeline Therapies: KSI 301, LKA651, ADVM-022, KVD001, MYL-1701P, Faricimab, REGN 910-3, EXN407, OPT-302, SF0166, AXT107, Brolucizumab, RC28-E, UBX1325, CT-P42, BAT5906, IBE-814, GB-102, THR-149, AR-13503, GSK2798745, BI 1026706, and APX3330 among others. Reach out how novel therapies are transforming the DME landscape @ Diabetic Macular Edema Pipeline Table of Contents Visit to know more of what’s covered @ Diabetic Macular Edema Emerging Therapies Related Reports Chronic Pain Associated With Painful Diabetic Neuropathy MarketDelveInsight's "Chronic Pain Associated with Painful Diabetic Neuropathy - Market Insights, Epidemiology, and Market Forecast-2030" report. Diabetic Foot Ulcers MarketDelveInsight’s ‘Diabetic Foot Ulcer (DFU) - Market Insights, Epidemiology, and Market Forecast—2030’ report. Diabetic Foot MarketDelveInsight's "Diabetic Foot - Market Insights, Epidemiology, and Market Forecast-2030" report. Diabetic Eye Disease MarketDelveInsight's "Diabetic Eye Disease - Market Insights, Epidemiology, and Market Forecast-2030" report. Diabetic Ketoacidosis MarketDelveInsight's "Diabetic Ketoacidosis (DKA) - Market Insights, Epidemiology, and Market Forecast-2030" report. Diabetic Gastroparesis Market SizeDelveInsight’s ‘Diabetic Gastroparesis (DGp) - Market Insights, Epidemiology and Market Forecast-2030’ report offers a detailed analysis of therapies and key pharmaceutical companies including Allergan Evoke Pharma Inc., Theravance Biopharma, Censa Pharmaceuticals, CinDome Pharma, Takeda (Millennium Pharmaceuticals, Inc.), Bird Rock Bio, and others. Diabetic Kidney Disease MarketDelveInsight's "Diabetic Kidney Disease (DKD) - Market Insights, Epidemiology, and Market Forecast-2030" report. Related Posts Understanding The Increasing Prevalence Of Diabetes And Its ComplicationsDiabetic Peripheral Neuropathy Market Landscape Diabetic Peripheral Neuropathy Medications About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing end-to-end comprehensive solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. For more insights, visit Pharma, Healthcare, and Biotech News

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100 Deals associated with LKA-651

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic macular oedema	Phase 2	PR	Novartis Pharmaceuticals Corp.	24 May 2019
Diabetic macular oedema	Phase 2	US	Novartis Pharmaceuticals Corp.	24 May 2019
Diabetic macular oedema	Phase 2	TR	Novartis Pharmaceuticals Corp.	24 May 2019
Diabetic macular oedema	Phase 2	DE	Novartis Pharmaceuticals Corp.	24 May 2019
Diabetic macular oedema	Phase 2	ES	Novartis Pharmaceuticals Corp.	24 May 2019
Diabetic macular oedema	Discovery	ES	Novartis Pharmaceuticals Corp.	24 May 2019
Diabetic macular oedema	Discovery	PR	Novartis Pharmaceuticals Corp.	24 May 2019
Diabetic macular oedema	Discovery	US	Novartis Pharmaceuticals Corp.	24 May 2019
Diabetic macular oedema	Discovery	TR	Novartis Pharmaceuticals Corp.	24 May 2019
Diabetic macular oedema	Discovery	DE	Novartis Pharmaceuticals Corp.	24 May 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03927690 (CTgov)	Phase 2	Diabetic macular oedema	91	LKA651 (LKA651)	baiimgmcev(ksgosrnqbu) = omvxowqttz mpwsrfinno (jduilnvckz, wleapfcdqg - ofczuqnrfo) View more	-	12 Oct 2023
				LKA651+Lucentis (LKA651 + Lucentis)	baiimgmcev(ksgosrnqbu) = dredfukcsn mpwsrfinno (jduilnvckz, yathwaqfib - ymtnmoghcy) View more

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