JAK1 inhibitors(Tyrosine-protein kinase JAK1 inhibitors), JAK2 inhibitors(Tyrosine-protein kinase JAK2 inhibitors), JAK3 inhibitors(Tyrosine-protein kinase JAK3 inhibitors)

Therapeutic Areas

Immune System DiseasesSkin and Musculoskeletal Diseases

Active Indication

Eczema, Dyshidrotic

Inactive Indication

Advanced Malignant Solid NeoplasmChronic dermatitisChronic eczema+ [11]

Originator Organization

Asana BioSciences LLCStartup

Active Organization

Formation Bio IncStartup

Inactive Organization

Asana BioSciences LLCStartup

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

Structure

Molecular FormulaC24H28N8O2

InChIKeyNLFLXLJXEIUQDL-UHFFFAOYSA-N

CAS Registry1425381-60-7

Clinical Trials associated with Gusacitinib

NCT06238531 / RecruitingPhase 1IIT

A Randomized, Double-Blind, Placebo-Controlled, Phase Ib Study to Evaluate the Safety, Tolerability, And Pharmacokinetics of Gusacitinib in Subjects With Systemic Lupus Erythematosus (SLE)

Background:
Systemic lupus erythematosus (SLE), also called lupus, is a disease that causes the body s immune system to attack healthy tissue. Lupus causes swelling and inflammation in the skin, skin, joints, kidneys, brain, blood vessels, and other organs. There is no cure for lupus. Current treatments do not help everyone and may have adverse effects. Better treatments are needed.
Objective:
To test a study drug (Gusacitinib) in people with lupus.
Eligibility:
People aged 18 years and older with lupus.
Design:
Participants will be screened. They will have a physical exam with blood and urine tests and a test of their heart function. They will have a chest X-ray. They will have tests that use blood pressure cuffs to measure blood flow and pressure throughout the body.
Participants will have 9 clinic visits and 6 phone visits over about 7 months.
The study has 3 parts.
Part 1: Gusacitinib is a tablet taken by mouth. Participants will be divided into 3 groups. One group will receive the study drug, and a second group will get a placebo. The placebo looks like the study drug but does not contain any medicine. Both of these groups will take their tablets once a day for 12 weeks. The third group will continue to take their usual medications for lupus throughout the study.
Part 2: All participants who took the study drug or placebo in part 1 will take the study drug once a day for 12 weeks.
Part 3: All participants who took the study drug will stop taking it for 4 weeks.

Start Date25 Dec 2024

Sponsor / Collaborator-

NCT04416516 / CompletedPhase 2

A Phase 2A Study to Assess the Safety and Efficacy of ASN-002 Combined With a Hedgehog Pathway Inhibitor in the Treatment of Multiple Low Risk Basal Cell Carcinomas in Sporadic or Basal Cell Nevus Syndrome Patients

The primary objectives are to:
Evaluate the safety and tolerability of intralesional ASN-002 when administered in combination with oral vismodegib in patients with Basal Cell Carcinomas (BCC)s;
Evaluate the efficacy of intralesional ASN-002 in target tumours when administered in combination with oral vismodegib in patients with BCCs.
The secondary objective is to:
1) Evaluate the efficacy of intralesional ASN-002 in non-target tumours when administered in combination with oral vismodegib in patients with BCCs.
The exploratory objective is to:
1) Evaluate immunological biomarkers during the course of treatment.

Start Date16 Jul 2020

Sponsor / Collaborator

Ascend Biopharmaceuticals Ltd.

NCT03728504 / CompletedPhase 2

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of ASN002 in Subjects With Moderate To Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy

Randomized double-blind/placebo study to evaluate the efficacy of ASN002 in subjects with severe chronic hand eczema.

Start Date03 Jan 2019

Sponsor / Collaborator

Asana BioSciences LLCStartup

100 Clinical Results associated with Gusacitinib

100 Translational Medicine associated with Gusacitinib

100 Patents (Medical) associated with Gusacitinib

Literatures (Medical) associated with Gusacitinib

01 Aug 2023·Journal of the American Academy of Dermatology

Oral spleen tyrosine kinase/Janus Kinase inhibitor gusacitinib for the treatment of chronic hand eczema: Results of a randomized phase 2 study

Article

Author: Fowler, Joseph ; Zammit, David J ; Bissonnette, Robert ; Rao, Niranjan ; Chen, Yusong ; Gupta, Sandeep ; Lee, Mark ; Denis, Louis ; Sofen, Howard L ; Jimenez, Pablo A

BACKGROUND:

Gusacitinib is an oral inhibitor of Janus and Spleen tyrosine kinases.

METHODS:

The efficacy and safety of gusacitinib were evaluated in a double-blind, placebo-controlled, multicenter, phase 2 study in 97 chronic hand eczema patients randomized (1:1:1) to placebo or gusacitinib (40 or 80 mg) for 12 weeks (part A). Then, in part B (through week 32), the patients received gusacitinib.

RESULTS:

At week 16, patients receiving 80 mg gusacitinib showed a 69.5% (P <.005) decrease in the modified total lesion-symptom score versus 49.0% for 40 mg (P =.132), and 33.5% for placebo. Considerable improvement in Physician's Global Assessment was seen in 31.3% of patients receiving 80 mg versus 6.3% of placebo (P <.05). A 73.3% decrease in the hand eczema severity index versus placebo (21.7%) occurred in patients receiving 80 mg (P <.001). Patients receiving 80 mg experienced a considerable decrease in hand pain (P <.05). As early as week 2, considerable reductions over placebo in modified total lesion-symptom score (P <.005), Physician's Global Assessment (P =.04), and hand eczema severity index (P <.01) were observed (80 mg gusacitinib). Adverse events included upper respiratory infection, headache, nausea, and nasopharyngitis.

CONCLUSIONS:

Gusacitinib showed rapid improvement in chronic hand eczema patients and was well tolerated, warranting further investigations.

01 Jun 2023·Journal of investigational allergology & clinical immunology

Updated Review on Treatment of Atopic Dermatitis.

Review

Author: Armario-Hita, J C ; Carrascosa, J M ; Ruiz-Villaverde, R ; Dodero-Anillo, J M ; Galán-Gutiérrez, M

Atopic dermatitis (AD) is a chronic or chronically recurrent Inflammatory dermatosis associated with multiple triggers that has a complex pathophysiological mechanism. It is characterized by a heterogeneous clinical expression, signs, and symptoms. Its etiology and pathogenesis are complex and are influenced by multiple immune-mediated factors. Treatment of AD can also be complex, given the high number of available drugs and multiple therapeutic targets. In this review, we summarize current literature on the efficacy and safety of topical and systemic drugs to treat moderate-to-severe AD. We begin with topical treatments such as corticosteroids and calcineurin inhibitors and subsequently address the latest systemic treatments, such as Janus kinase inhibitors (upadacitinib, baricitinib, abrocitinib, gusacitinib) and interleukin (IL) inhibitors, which have proven efficacious in AD, namely, dupilumab (IL-4 and IL-13), tralokinumab (IL-13), lebrikizumab (IL-13), and nemolizumab (IL-31). Given the large number of drugs available, we summarize the pivotal clinical trials for each drug, evaluate recent real-world experience in terms of safety and efficacy for purposes of compilation, and provide evidence to guide the optimal choice of therapy.

01 Aug 2022·Journal of the American Academy of Dermatology

The efficacy and safety of Janus kinase inhibitors in patients with atopic dermatitis: A systematic review and meta-analysis

Review

Author: Chen, Jingsi ; Tu, Wei ; Cheng, Jun ; Luo, Xiaoyan ; Yang, Huan ; Wang, Hua ; Zhang, Yan

This study systematically review the efficacy and safety of JAKis among existing randomized, double-blinded, and placebo-controlled clin. trials of JAKis for the treatment of AD.This study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and registered in PROSPERO (CRD42020188514).We searched electronic databases (Embase, PubMed, and Cochrane Central Register of Controlled Trials) from their inception to Sept. 16, 2021.A total of 25 studies were finally included in the meta-anal., including 8 studies on topical JAKis and 17 on oral JAKis.Four kinds of topical JAKis (tofacitinib ointment, delgocitinib ointment, delgocitinib cream, and ruxolitinib cream) were applied, and 5 kinds of oral JAKis (baricitinib, abrocitinib, ASN002, SHR0302, and upadacitinib) were given at varying dosages.Overall, compared with placebos, the use of JAKis showed a significant improvement in the lesion score and pruritus: Eczema Area and Severity Index score (standard mean difference [95% CI], 0.79 [ 0.97 to 0.61]; P < .00001); investigators global assessment score (odds ratio [OR] [95% CI], 5.08 [3.78-6.82]; P < .00001); and pruritus numerical rating scale (standard mean difference [95% CI], 0.49 [ 0.67 to 0.32]; P < .00001).Although no significant adverse effects (AEs) were found for the topical JAKis, the oral JAKis showed an increased risk of at least 1 AE (OR [95% CI], 1.23 [1.11-1.36]; P < .0001) and the following most frequently reported AEs: gastrointestinal disorders (OR [95% CI], 2.49 [1.84-3.37]; P < .00001), nasopharyngitis (OR [95% CI], 1.23 [1.04-1.46]; P = .02), and headache (OR [95% CI], 1.57 [1.23-2.00]; P = .0003).Because of the higher risk of gastrointestinal disorders, nasopharyngitis, and headache during oral JAKi treatments, more attention should be paid to the AEs of patients treated with oral JAKis.

News (Medical) associated with Gusacitinib

26 Jun 2024

·www.fiercebiotech.com

AI-focused Formation secures Sanofi-backed $372M series D to license more drugs

Formation Bio said it plans to deploy new capital to continue to acquire and in-license clinical-stage assets from its biotech and pharma partners. Megarounds have been few and far between in 2024, but Formation Bio has managed to draw in an impressive $372 million series D as the AI-focused biotech seeks to expand its pipeline. AI companies like to promise the world, but Formation’s offering is more mundane. The idea is that Formation will partner with biotechs to improve their workflow automation—such as generating tailored patient recruitment content for specific cohorts of a clinical trial or speedily producing AI-generated adverse event reports. The ambition accelerates when the company looks ahead to the “medium term,” when it hopes to assemble a so-called “AI R&D Scientist” that can “provide drug development teams with decision support and eventually steer high-quality R&D decisions.” “In the long term, the company's goal is to build and train AI models that can better predict toxicity, tolerability, and one day, efficacy,” Formation explained in a June 26 release. The series D was led by a16z with “significant participation” from existing partner Sanofi—which has other AI-focused collaborations with partners including the likes of Owkin and Exscientia. Formation, which was formerly known as TrialSpark, said it plans to deploy this capital to continue to acquire and in-license clinical-stage assets from its biotech and pharma partners. The company currently lists three candidates in its clinical pipeline, including a SYK/JAK inhibitor called gusacitinib in phase 3 development for chronic hand eczema. There’s also a sodium channel blocker called ASN008 in phase 2 trials for notalgia paresthetica and itch associated with atopic dermatitis as well as an FGF18 drug called sprifermin in phase 2 for knee osteoarthritis. Both gusacitinib and ASN008 were bought from Asana BioSciences in 2022, while sprifermin was licensed from Merck KGaA. “By partnering with Formation Bio, smaller biotechs can advance more than just their lead asset, creating a pathway for other drugs in their pipeline,” the company said in the release. “For large pharma companies, Formation Bio creates an ‘off balance sheet’ pathway for development, enabling a company to take more shots on goal in a P&L efficient way.” Sanofi already announced a drug development partnership with both Formation and OpenAI last month. CEO Paul Hudson used a statement in this morning’s release to reemphasize that the French pharma is “all in on AI.” “We are proud to partner with and invest in Formation Bio, whose AI-driven drug development vision and capabilities will help lead our industry forward in the shared ambition to accelerate and improve how we bring more new medicines to patients,” Hudson added.

Phase 2Acquisition

23 May 2023

·www.prnewswire.com

TrialSpark Announces First Patient Dosed in Phase 2 Clinical Trial for ASN008-201 in Atopic Dermatitis

NEW YORK, May 23, 2023 /PRNewswire/ -- TrialSpark, Inc. announced today that the first patient has been dosed in its Phase 2 clinical trial for ASN008-201, a topical sodium channel blocker in development for pruritus associated with atopic dermatitis (AD). This clinical trial is a randomized, double-blind, vehicle-controlled, Phase 2 trial to evaluate the anti-pruritic efficacy, safety, tolerability, and pharmacokinetics of ASN008 in adults with mild to moderate AD (NCT05870865). Topline data for this trial is expected in 2024. Atopic dermatitis is a chronic inflammatory skin disease, and pruritus is the most burdensome and prevalent symptom in patients suffering from AD. Treating atopic itch, which impacts more than 16.5 million patients in the US, has historically been a challenge due to an incomplete understanding of the multiple mechanisms underlying its pathogenesis. "We are thrilled to have dosed our first patient in this clinical trial," said Gavin Corcoran, Chief Development Officer at TrialSpark. "Dermatology is a core focus area for our company, and there is enormous unmet patient need, so we're looking forward to progressing this clinical trial as efficiently as possible." This clinical trial will enroll approximately 120 participants at around 28 study sites across the United States. Eligible participants will be randomized in a 1:1:1:1 ratio to receive ASN008 gel 1.25%, ASN008 gel 2.5%, ASN008 gel 5%, or matching vehicle twice a day for 4 weeks (28 days), followed by a 4-week (28-day) follow-up period. "We are grateful to the patients who are participating in this clinical trial and to the healthcare professionals who are working with us to advance our research," said Benjamine Liu, TrialSpark CEO and Co-Founder. "Our company's mission is to bring new treatments to patients faster than ever before, and the contributions of patients, doctors, and sites are essential to achieving that goal." For more information about the clinical trial, please visit . About TrialSpark Founded in 2016, TrialSpark is a tech-driven pharma company differentiated by radically more efficient drug development. TrialSpark has built a technology platform that optimizes all aspects of clinical drug development, enabling more efficient trial design, faster trial completion, and higher quality trial data. The company acquires clinical-stage drugs from pharmaceutical and biotech companies and develops them faster, unlocking greater value per program and accelerating access to new treatments for patients. TrialSpark's current therapeutic areas of focus include rheumatology, dermatology, and cardiometabolic diseases. TrialSpark is actively growing its development pipeline. In November 2022, the company announced the formation of Libertas Bio following the acquisition of a majority position in a portfolio of immunodermatology assets from Asana BioSciences. The Libertas Bio pipeline includes ASN008, as well as global rights to gusacitinib, an oral Phase 3-ready dual JAK/SYK inhibitor in development for chronic hand eczema. TrialSpark also announced the formation of Highline Bio following the acquisition of worldwide rights to sprifermin - a potential first-in-class disease modifying treatment for osteoarthritis - from Merck KGaA, Darmstadt, Germany. Media Contact: [email protected] BD/Partnerships Contact: [email protected] SOURCE TrialSpark

Phase 2Acquisition

29 Nov 2022

·www.biospace.com

TrialSpark announces acquisition of a clinical-stage immunodermatology portfolio and formation of Libertas Bio

NEW YORK, Nov. 29, 2022 /PRNewswire/ -- TrialSpark announced today the formation of Libertas Bio following the acquisition of a majority position in a portfolio of immunodermatology assets from Asana BioSciences. The Libertas Bio pipeline now includes global rights to gusacitinib, an oral Phase 3-ready dual JAK/SYK inhibitor in development for chronic hand eczema, and ASN008, a Phase 2-ready topical sodium channel blocker in development for pruritus associated with atopic dermatitis. Libertas Bio will continue the development of these assets, leveraging TrialSpark's tech-enabled drug development capabilities to bring these therapies to patients faster and more efficiently. Financial terms of the transaction were not disclosed. After acquiring a portfolio of immunodermatology assets from Asana BioSciences, TrialSpark forms Libertas Bio. Gusacitinib has the potential to be the first oral therapy approved in the US for the treatment of chronic hand eczema (CHE). In a phase 2b study, Gusacitinib 80mg was shown to have a statistically significant and potentially clinically meaningful improvement across both primary and secondary endpoints and was well tolerated. CHE is an underserved condition with high unmet need, impacting up to 10% of adults, with no approved treatments in the US and few available off label options. CHE has a significant negative impact on quality of life, including psychosocial health and workforce productivity, and can lead to a number of comorbidities such as sleep disturbance and depression. ASN008 has shown promising efficacy data in pruritus (itch) associated with atopic dermatitis, and is a Phase 2-ready complementary pipeline program to gusacitinib. Chronic itch is a hallmark of atopic dermatitis, which impacts more than 16.5 million patients in the US. ASN008 has the potential to be used in combination with other topical and systemic therapies in atopic dermatitis, as well as a meaningful opportunity to expand into other itch and pain related indications. "We are excited about the opportunity to add these important products to our portfolio of development assets," said Dr. Gavin Corcoran, TrialSpark's Chief Medical Officer. "Both chronic hand eczema and itch are conditions that negatively affect the lives of the patients that have them, as well as their families. An effective treatment has the potential to improve the quality of life for both." Beyond gusacitinib and ASN008, the transaction also included a preclinical dual JAK/SYK inhibitor named ASN011. Libertas Bio is open to in-licensing additional complementary products to build a differentiated pipeline focused on immunodermatology treatments. Prior to this transaction, TrialSpark has in-licensed multiple assets, deploying capital and pursuing the development of drug programs as part of its mission to bring new treatments to patients faster and more efficiently. As part of its business development strategy, TrialSpark uses balance sheet capital to develop, acquire and/or license assets, leveraging its in-house drug development engine to run trials significantly faster and more efficiently than industry standards. TrialSpark is actively pursuing partnerships with both small biotech and larger pharma companies through flexible and creative collaboration structures, maximizing the potential value of drug candidates for all stakeholders through faster and more efficient clinical development programs. For example, the company recently partnered with global pharmaceutical company Sanofi to jointly acquire and develop novel therapies. TrialSpark is focused on clinical stage assets in rheumatology, dermatology, CNS, and cardiometabolic diseases, with a focus on chronic diseases that are treated outside of a hospital setting. About TrialSpark Founded in 2016, TrialSpark is a tech-driven pharma company differentiated by radically more efficient drug development. TrialSpark has built a technology platform that optimizes all aspects of clinical drug development, enabling more efficient trial design, faster trial completion, and higher quality trial data. The company acquires clinical-stage drugs from pharmaceutical and biotech companies and develops them faster, unlocking greater value per program and accelerating access to new treatments for patients. TrialSpark's current therapeutic areas of focus include rheumatology, dermatology, CNS, and cardiometabolic diseases. Contacts TrialSpark Business Development: jorge.ramirez@trialspark.com TrialSpark Press Inquiries: lily@trialspark.com

Phase 2Clinical ResultDrug ApprovalImmunotherapyAcquisition

100 Deals associated with Gusacitinib

External Link

KEGG	Wiki	ATC	Drug Bank
D11676	-	-	DB15670

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Eczema, Dyshidrotic	Phase 3	US	Formation Bio IncStartup	-
Chronic dermatitis	Phase 2	US	Asana BioSciences LLCStartup	03 Jan 2019
Chronic dermatitis	Phase 2	CA	Asana BioSciences LLCStartup	03 Jan 2019
Chronic eczema	Phase 2	US	Asana BioSciences LLCStartup	03 Jan 2019
Chronic eczema	Phase 2	CA	Asana BioSciences LLCStartup	03 Jan 2019
Moderate Atopic Dermatitis	Phase 2	US	Asana BioSciences LLCStartup	05 Jul 2018
Moderate Atopic Dermatitis	Phase 2	CA	Asana BioSciences LLCStartup	05 Jul 2018
Moderate Atopic Dermatitis	Phase 2	DE	Asana BioSciences LLCStartup	05 Jul 2018
Severe Atopic Dermatitis	Phase 2	US	Asana BioSciences LLCStartup	05 Jul 2018
Severe Atopic Dermatitis	Phase 2	CA	Asana BioSciences LLCStartup	05 Jul 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03654755 (CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	162	ASN002 (ASN002 40 mg)	poxxkszknv(tuvriwzmno) = wwvnmanwwr ajgzqmidiw (fofcerldte, mdkaatqxsm - sejdxibzld) View more	-	18 Sep 2023
				ASN002 (ASN002 60 mg)	poxxkszknv(tuvriwzmno) = zivcmekmbq ajgzqmidiw (fofcerldte, wxeevqqomk - qebmfkmazw) View more
NCT02440685 (CTgov)	Phase 1/2	Mantle-Cell Lymphoma \| Follicular Lymphoma \| Chronic Lymphocytic Leukemia ... View more	51	ASN002 (10 mg BID)	eycvcpblay(oqwekkxmwo) = tmwwdmgbjb atseqaetpq (djjqiyjvth, xwifxeynzk - ensviuezqt) View more	-	07 Jun 2023
				ASN002 (20 mg BID)	eycvcpblay(oqwekkxmwo) = kaqbxlpnsm atseqaetpq (djjqiyjvth, wnktudxsyk - hbjkzkidsd) View more
NCT03728504 (CTgov)	Phase 2	Chronic eczema \| Chronic dermatitis	97	ASN002 (ASN002 40 mg)	puejbekaet(upnsmrqiyu) = mncqpsonmu xdcrfpvkgq (yforvbvohy, ullmfksuxw - wlegcjdaru) View more	-	09 May 2023
				ASN002 (ASN002 80 mg)	puejbekaet(upnsmrqiyu) = oaqiyzjyvz xdcrfpvkgq (yforvbvohy, emnflotybq - qjlzfxhdpw) View more
NCT03531957 (CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	244	ASN002 (ASN002 40 mg)	cvtzckqpkg(heledeifjj) = oarxglkrue nraffhzcuj (xfvqvxcevo, vfqgvxveji - iymiisyqas) View more	-	15 Nov 2022
				ASN002 (ASN002 60 mg)	cvtzckqpkg(heledeifjj) = gewvtccadi nraffhzcuj (xfvqvxcevo, uwkpzhnzbz - ncmobllwqt) View more

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