A Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of Topical SM04755 Solution Following Topical Administration to Subjects with Mild to Moderate Plaque Psoriasis

Start Date09 Oct 2017

Sponsor / Collaborator-

NCT03502434 / CompletedPhase 1

A Phase 1, Single-Center, Repeat Insult Patch Test (RIPT) Study Evaluating the Sensitization Potential of Topical SM04755 Solution

This is a single center, randomized, controlled, within subject comparison, single dose study to determine the sensitization potential of SM04755 solution on normal skin under semi-occlusive patch conditions.

Start Date11 Sep 2017

Sponsor / Collaborator

Biosplice Therapeutics, Inc.

NCT03229291 / CompletedPhase 1

A Phase 1, Single-Center, Randomized, Single-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SM04755 Following Topical Administration to Healthy Subjects

This study is a single-center, randomized, single-blind, placebo-controlled, multiple ascending dose study of SM04755 solution applied topically once daily for 14 days to intact skin overlying the inner thigh of healthy subjects at an estimated body surface area (BSA) of 80 cm^2. Dosing cohorts will consist of 8 subjects who will be randomized 3:1 (SM04755:placebo).

Start Date03 Nov 2016

Sponsor / Collaborator

Biosplice Therapeutics, Inc.

100 Clinical Results associated with SM-04755

100 Translational Medicine associated with SM-04755

100 Patents (Medical) associated with SM-04755

Literatures (Medical) associated with SM-04755

01 Sep 2021·Journal of Orthopaedic ResearchQ3 · MEDICINE

SM04755, a small‐molecule inhibitor of the Wnt pathway, as a potential topical treatment for tendinopathy

Q3 · MEDICINE

Article

Author: Deshmukh, Vishal ; Ghias, Abdullah ; O'Green, Alyssa L. ; Hood, John ; Yazici, Yusuf ; Ibanez, Maureen ; Barroga, Charlene ; KC, Sunil ; Hofilena, Brian ; Seo, Tim ; Kennedy, Sarah ; Dellamary, Luis ; Chiu, Kevin ; Tambiah, Jeyanesh ; Stewart, Joshua

AbstractThe Wnt pathway is upregulated in tendinopathy, affecting inflammation and tenocyte differentiation. Given its potential role in tendinopathy, this signaling pathway may be a relevant target for treatment. The current study examined the therapeutic potential of SM04755, a topical, small‐molecule Wnt pathway inhibitor, for the treatment of tendinopathy using in vitro assays and animal models. In vitro, SM04755 decreased Wnt pathway activity, induced tenocyte differentiation, and inhibited catabolic enzymes and pro‐inflammatory cytokines in human mesenchymal stem cells, rat tendon‐derived stem cells, and human peripheral blood mononuclear cells. Evaluation of the mechanism of action of SM04755 by biochemical profiling and computational modeling identified CDC‐like kinase 2 (CLK2) and dual‐specificity tyrosine phosphorylation‐regulated kinase 1A (DYRK1A) as molecular targets. CLK and DYRK1A inhibition by siRNA knockdown or pharmacological inhibition induced tenocyte differentiation and reduced tenocyte catabolism. In vivo, topically applied SM04755 showed therapeutically relevant exposure in tendons with low systemic exposure and no detectable toxicity in rats. Moreover, SM04755 showed reduced tendon inflammation and evidence of tendon regeneration, decreased pain, and improved weight‐bearing function in rat collagenase‐induced tendinopathy models compared with vehicle control. Together, these data demonstrate that CLK2 and DYRK1A inhibition by SM04755 resulted in Wnt pathway inhibition, enhanced tenocyte differentiation and protection, and reduced inflammation. SM04755 has the potential to benefit symptoms and modify disease processes in tendinopathy.

100 Deals associated with SM-04755

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Tendinopathy	Phase 1	US	Biosplice Therapeutics, Inc.	03 Nov 2016
Colorectal Cancer	Phase 1	US	Biosplice Therapeutics, Inc.	19 Jun 2014
Liver Cancer	Phase 1	US	Biosplice Therapeutics, Inc.	19 Jun 2014
Pancreatic Cancer	Phase 1	US	Biosplice Therapeutics, Inc.	19 Jun 2014
Stomach Cancer	Phase 1	US	Biosplice Therapeutics, Inc.	19 Jun 2014
Scleroderma, Systemic	Phase 1	US	Biosplice Therapeutics, Inc.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EULAR2018	Not Applicable	Psoriasis	-	SM04755	(ytemnfcwxy) = kudiyayozf buswhgbabf (mavcyprxbh ) View more	Positive	13 Jun 2018
EULAR2018	Not Applicable	Psoriasis	-	Vehicle	(ytemnfcwxy) = tgdzapvlqf buswhgbabf (mavcyprxbh ) View more	Positive	13 Jun 2018
ACR2016	Not Applicable	Tendinopathy	-	SM04755	pusyyfokfw(zpzjahjzvt) = zxjpykvgka bfhnjdhozi (iijneqccho )	Positive	14 Nov 2016

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