Delving into the Latest Updates on SHJ-002 with Synapse

Overview

Basic Info

Drug Type

ASO

Synonyms

microRNA-328 antisense oligonucleotide - Sunhawk Vision Biotech, SHJ 002, SHJ-002

Target

miR-328

Action

inhibitors

Mechanism

miR-328 inhibitors(microRNA 328 inhibitors), Epigenetic drug

Therapeutic Areas

Immune System DiseasesInfectious DiseasesEye Diseases+ [2]

Active Indication

Myopia, DegenerativeCorneal UlcerSjogren's Syndrome

Inactive Indication-

Originator Organization

Sunhawk Vision Biotech, Inc.

Active Organization

Sunhawk Vision Biotech, Inc.

Inactive Organization

DreamHawk Vision Biotech, Inc.

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Structure/Sequence

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This was a single-center, open-label, first-in-human trial in healthy children (NCT04928144). All subjects received the study medication. The trial had 2 stages. Stage 1 was an intrasubject dose-escalation study, and stage 2 was the highest tolerable dose study. The SHJ002 ophthalmic solution was instilled in a randomly selected study eye in each participant, whereas the other untreated eye served as a negative control. Three participants were assigned to stage 1, and they received eye drops of 3 concentrations (0.025%, 0.08%, and 0.25%), each of which was used for 3 consecutive days. The highest tolerable dose from stage 1 was used in stage 2 where another 9 participants were recruited for 28-day treatment. Ocular assessments, physical examination, and vital signs were measured to evaluate safety and tolerability.

FINDINGS:

There were 4 boys and 8 girls with a mean age of 12.3 years and a SD of 1.56. All participants were Asians. All 3 concentrations used in stage 1 were well tolerated, and the dose of 0.25% was used in stage 2. There were no reports of discomfort. There was only 1 mild adverse event (punctate keratitis) in the untreated eye in 1 participant, which was deemed as "unrelated to study drug."

IMPLICATIONS:

SHJ002 is a novel microRNA therapy that uses eye drop instillation. SHJ002 ophthalmic solution is generally safe and tolerable, which warrants further investigations in Phase II and III trials.

CLINICALTRIALS:

gov identifier: NCT04928144.

RSC advancesQ3 · CHEMISTRY

A simple colorimetric and ratiometric fluoride ion probe with large color change

Q3 · CHEMISTRY

ArticleOA

Author: Li, Xiangguo ; Liu, Jian ; Zhang, Gang ; Shi, Heng ; Chen, Hongjin ; Zhang, Rui ; Xing, Jieni

Two colorimetric and ratiometric fluoride ion probes SHJ-1 and SHJ-2 based on the acylhydrazone skeleton have been developed.

Graefe's Archive for Clinical and Experimental Ophthalmology

Quintessence of currently approved and upcoming treatments for dry eye disease

Review

Author: Sawale, Gayatri ; Ghuge, Santosh ; Patil, Sunanda ; Sathaye, Sadhana

Dry eye disease (DED), also known as dry eye syndrome, is a multifactorial ocular surface disease. The aim of this review is to present the details of currently approved and upcoming treatment options for DED in a nutshell. We conducted a thorough literature search using PubMed and searched US FDA website, clinicaltrials.gov, and data available in public domain for currently approved and upcoming treatment options for DED. Currently, the US Food and Drug Administration (FDA)-approved medical treatments for treatment of DED include cyclosporine formulations (RESTASIS^® [cyclosporine 0.05% ophthalmic emulsion], VEVYE^® [cyclosporine 0.1% ophthalmic solution], and CEQUA™ [cyclosporine 0.09% ophthalmic solution]), XIIDRA^® (lifitegrast), a leukocyte function-associated antigen-1 (LFA-1)/intracellular adhesion molecule-1(ICAM-1) inhibitor, EYSUVIS™ (loteprednol etabonate ophthalmic suspension 0.25%), a corticosteroid, and MIEBO™ (perfluorohexyloctane ophthalmic solution), a semifluorinated alkane. TYRVAYA™ (varenicline solution nasal spray), a cholinergic agonist, is another formulation approved for the treatment of the signs and symptoms of DED. The medical devices approved for treating DED due to meibomian glands dysfunction (MGD) include Lumenis OptiLight™ (intense pulsed light [IPL] device), TearCare^® system, and TearScience™ LipiFlow™ thermal pulsation system. Punctal plugs are another treatment option approved for management of DED. There are hundreds of clinical studies evaluating newer treatments for managing the signs and symptoms. Cyclosporine formulations TJO-087 (cyclosporine A nanoemulsion 0.08%), SCAI-001 eye drops (cyclosporine 0.01%, 0.02%) are being evaluated against RESTASIS^® and other approved treatments. The potential treatments being assessed include IC 265, OK-101, PL9643, SYL1001 (tivanisiran), SHJ002, OXERVATE^® (cenegermin-bkbj ophthalmic solution 0.002%), HBM9036 (tanfanercept ophthalmic solution), OCS-02 (licaminlimab), MIM-D3 (tavilermide ophthalmic solution 5%), AR-15,512, BRM421, reproxalap, and AZR-MD-001 (selenium sulphide ointment 0.5%). The pathophysiology of DED is complex and multifactorial; there is a need to understand it even deeper. The new treatments and different delivery systems seem promising and provide a hope of effective treatment for DED.

100 Deals associated with SHJ-002

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Myopia, Degenerative	Phase 2	United States	Sunhawk Vision Biotech, Inc.	22 Jan 2025
Myopia, Degenerative	Phase 2	Taiwan Province	Sunhawk Vision Biotech, Inc.	22 Jan 2025
Corneal Ulcer	Phase 2	Taiwan Province	Sunhawk Vision Biotech, Inc.	28 Jun 2024
Sjogren's Syndrome	Phase 2	Taiwan Province	Sunhawk Vision Biotech, Inc.	28 Jun 2024
Dry Eye Syndromes	Phase 2	Australia	DreamHawk Vision Biotech, Inc.	08 Feb 2023
Dry Eye Syndromes	Phase 2	Taiwan Province	DreamHawk Vision Biotech, Inc.	08 Feb 2023
Dry Eye Syndromes	Phase 2	Thailand	DreamHawk Vision Biotech, Inc.	08 Feb 2023

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05486728 (CTgov)	Phase 2	Dry Eye Syndromes	85	SHJ002/Vehicle (SHJ002)	njzrxwaizo(cvhzdmohgg) = ppvfdwltyq siogkykkfc (jflqstdnyl, sujpratlna - knyztkmyds) View more	-	14 Oct 2025
				SHJ002/Vehicle (Vehicle)	njzrxwaizo(cvhzdmohgg) = awwtonxnyq siogkykkfc (jflqstdnyl, euonljmdky - mcuhrdrwqm) View more
NCT06381986 (CTgov)	Phase 2	Corneal Ulcer \| Sjogren's Syndrome	116	SHJ002 (SHJ002)	emdsbgzznh(gqcctxofxr) = wfswnztmpp kwijrnondf (mdoaodkxof, utbyeziavh - esigiqfbjj) View more	-	22 Aug 2025
				Vehicle (Vehicle)	emdsbgzznh(gqcctxofxr) = xxxntrldwm kwijrnondf (mdoaodkxof, azbnrcgptn - dtefyuwcmr) View more