Delving into the Latest Updates on Silk derived protein 4(Silk Technologies, Inc.) with Synapse

Overview

Basic Info

Drug Type

Protein drugs

Synonyms

Amlisimod, SDP-4 Ophthalmic Solution, Silk derived protein 4

+ [1]

Target

NF-κB

Action

inhibitors

Mechanism

NF-κB inhibitors(Nuclear factor NF-kappa-B complex inhibitors)

Therapeutic Areas

Eye Diseases

Active Indication

Xerophthalmia

Inactive Indication-

Originator Organization

Silk Technologies, Inc.

Active Organization

Silk Technologies, Inc.

Inactive Organization

Silk Technologies Ltd.

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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SDP-4-CS202 is a Phase 2, multicenter, double-masked, randomized, vehicle-controlled, parallel group study designed to evaluate the ocular efficacy of SDP-4 ophthalmic solution in subjects with moderate to severe dry eye disease over an 8-week treatment period. Once concentration (1%) of SDP-4 ophthalmic solution will be given in a parallel group to vehicle via topical ocular instillation BID.

Start Date14 Aug 2020

Sponsor / Collaborator

Silk Technologies Ltd.

NCT03889886

/ CompletedPhase 2

A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel Group, Dose-Response Study of SDP-4 Ophthalmic Solution in Subjects With Dry Eye Disease (DED)

SDP-4-CS201, is a Phase 2, multi-center, double-masked, randomized, vehicle-controlled, dose-response, parallel-group study designed to evaluate the ocular and systemic safety and efficacy of SDP-4 ophthalmic solution in subjects with moderate to severe dry eye disease over a 12-week treatment period. Three concentrations (0.1%, 1.0% and 3.0%) of SDP-4 ophthalmic solution will be given to parallel groups via topical ocular instillation BID.

Start Date16 Apr 2019

Sponsor / Collaborator

Silk Technologies Ltd.

100 Clinical Results associated with Silk derived protein 4(Silk Technologies, Inc.)

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100 Translational Medicine associated with Silk derived protein 4(Silk Technologies, Inc.)

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100 Patents (Medical) associated with Silk derived protein 4(Silk Technologies, Inc.)

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4

Literatures (Medical) associated with Silk derived protein 4(Silk Technologies, Inc.)

28 Jan 2025·ACS Omega

Comprehensive Physicochemical Characterization and in Vitro Human Cell Culture Studies of an Innovative Biocompatible and Biodegradable Silk-Derived Protein Hydrolysate, SDP-4

Article

Author: Infanger, David W. ; Aggarwal, Saurabh ; Mansour, Heidi M. ; Lora, Andrea J. ; Shafi, Hasham ; Lawrence, Brian D.

SDP-4 is a soluble silk fibroin-derived protein hydrolysate extracted from the Bombyx mori silkworm cocoon and is a novel first-in-class biopolymer that is biodegradable, biocompatible, and shown to have regenerative properties. SDP-4 is currently used as a commercial wetting agent in topical eye drops, but it has also been shown to have anti-inflammatory properties that could be utilized in other biomedical applications. The purpose of this study was to comprehensively characterize the physicochemical properties that are necessary to design formulations and examine cell viability in response to varying doses of SDP-4 on different human cell types, with a particular attention toward respiratory applications. Lyophilized SDP-4 powder was characterized by scanning electron microscopy (SEM), energy-dispersive X-ray (EDX) spectroscopy, differential scanning calorimetry (DSC), hot-stage microscopy (HSM), Karl Fisher (KF) coulometric titration, Raman spectrometry, confocal Raman microscopy (CRM), and Fourier transform infrared microscopy. The lyophilized powder exhibited a nonuniform, angular glassy flake morphology with uniform chemical composition and minimal moisture uptake when tested under varying humidity conditions. Crystalline character was evident through birefringence at ambient temperature which changed during phase transitions, as evidenced through qualitative and quantitative assessments. Dose ranging SDP-4 biocompatibility studies on different human lung cells, nasal cells, skin cells, and brain cells was assessed by the in vitro cell viability assay. Assay results showed that cell viability was maintained at the various doses studied for different human cell types. The transepithelial resistance (TEER) assay showed that SDP-4 leads to transient fluctuations in cell membrane integrity and barrier tightness, followed by a recovery phase as cells adapt or repair the junctions. These findings demonstrate that SDP-4 is biocompatible with different types of human cells and safe at all of the doses studied. The unique physicochemical properties of SDP-4 revealed in this study demonstrate its favorable formulating ability for a variety of potential therapeutic applications.

01 Jan 2025·American Journal of Ophthalmology

Silk-Derived Protein-4 Versus Vehicle Control in Treating Patients With Moderate to Severe Dry Eye Disease: A Randomized Clinical Trial

Article

Author: Karpecki, Paul M. ; Lawrence, Brian D. ; Karpecki, Paul M ; Lawrence, Brian D ; Levy, Brian ; Infanger, David W. ; Infanger, David W

PURPOSEIn this study the safety and efficacy of silk-derived protein 4 (SDP-4), also known as amlisimod, eye drops against a vehicle control formulation in patients with moderate to severe dry eye disease (DED) was assessed. SDP-4 is a novel, naturally derived, anti-inflammatory wetting agent that enhances coating on the ocular surface.DESIGNExploratory Phase 2, 12- and 8-week, serial cohort, multicenter, double-masked, randomized, vehicle-controlled study.METHODSIn the first cohort (N = 305), patients were randomized 1:1:1:1 to SDP-4 (0.1%, 1%, 3% wt./wt.) or vehicle control and dosed 2 times per day (BID), while in the second cohort patients were randomized 1:1 with 1% wt./wt. SDP-4, the best performing formulation from the first cohort, or vehicle control BID (N = 151). Diagnosed DED patients were treated in the United States between April 2019 and May 2021. The first cohort of subjects had moderate to severe baseline symptoms, while the second cohort had moderate baseline symptoms to study the impact of baseline symptoms on SDP-4 performance. Key sign and symptom end points were mean change from baseline in TBUT and total SANDE score (0-100 visual analog scale) throughout the study.RESULTSSDP-4 (1%) significantly increased TBUT vs the vehicle control (P < .05) at days 28 and 56 in the first cohort, and patient symptomatology from baseline was reduced by 46% based on subject reported SANDE VAS scores at day 84. Patients with more severe baseline DED symptoms experienced a significantly greater amount of relief than when compared to patients with moderate DED (P < .05). All treatment groups were well tolerated with a 2.6% total discontinuation rate.CONCLUSIONSTo the best of our knowledge, this was the first-in-human use of SDP-4 in a clinical trial. SDP-4 is a first-in-class protein ingredient that offers a safe and multi-modal treatment approach for alleviating severe DED symptoms within a novel formulation.

10 Oct 2022·ACS Biomaterials Science & Engineering

Efficacy Evaluation of SDF-1α-Based Polypeptides in an Acute Myocardial Infarction Model Using Structure-Based Drug Design

Article

Author: Pirzada, Rameez Hassan ; Park, Yongdoo ; Santos, Ana Rita M. P. ; Kim, Jongseong ; Shah, Masaud ; Kang, Yong Guk ; Song, Myeongjin ; Choi, Sangdun ; Chae, Yun Jin ; Lee, Kang-Gon

Stromal cell-derived factor-1 alpha (SDF-1α, CXCL12) mediates the migration of circulating cells to desired sites for tissue development, homeostasis, and regeneration and can be used to promote cardiac regeneration by recruiting stem cells. However, the use of SDF-1α in the injured heart necessitates not only higher binding affinity to its receptor, CXCR4+, but also better robustness against enzymatic degradation than other SDF-1 isoforms. Here, we conduct a screening of SDF-1α analog peptides that were designed by structure-based drug design (SBDD), a type of computer-aided drug design (CADD). We have developed in vitro and in vivo methods that enable us to estimate the effect of peptides on the migration of human mesenchymal stem cells (hMSCs) and cardiac regeneration in acute myocardial infarction (AMI)-induced animals, respectively. We demonstrate that one type of SDF-1α analog peptide, SDP-4, among the four analog peptides preselected by SBDD, is more potent than native SDF-1α for cardiac regeneration in myocardial infarction. It is interesting to note that the migratory effects of SDP-4 determined by a wound healing assay, a Transwell assay, and a 2D migration assay are comparable to those of SDF-1α. These results suggest that in vivo, as well as in vitro, screening of peptides developed by SBDD is a quintessential process to the development of a novel therapeutic compound for cardiac regeneration. Our finding also has an implication that the SDP-4 peptide is an excellent candidate for use in the regeneration of an AMI heart.

100 Deals associated with Silk derived protein 4(Silk Technologies, Inc.)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Xerophthalmia	Phase 2	-	Silk Technologies, Inc.	-
Dry Eye Syndromes	Preclinical	United States	Silk Technologies Ltd.	16 Apr 2019

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03889886 (SDP-4-CS201, CTgov)	Phase 2	Dry Eye Syndromes	305	Vehicle (Vehicle)	caiyjtynlg(qzropqhvfq) = gwqyqbiqpl iykfrbxuwd (rghnbxejrt, zwnmmeojlv - fuukjcxmao) View more	-	02 Sep 2022
				SDP-4 Ophthalmic Solution (0.1%) (SDP-4 Ophthalmic Solution (0.1%))	caiyjtynlg(qzropqhvfq) = hiixntdaqu iykfrbxuwd (rghnbxejrt, kdddxvurle - bgfofxafcg) View more
NCT04535947 (SDP-4-CS202, CTgov)	Phase 2	Dry Eye Syndromes	153	Vehicle (Vehicle)	ltjsnmrfog(gffngeaqfv) = wfhiraifvy ujiigvwxcq (vkqdwpaelw, sydtunsgkz - vvrfnqcehi) View more	-	01 Sep 2022
				SDP-4 Ophthalmic Solution (1.0%) (SDP-4 Ophthalmic Solution (1.0%))	ltjsnmrfog(gffngeaqfv) = lwmuiyngfk ujiigvwxcq (vkqdwpaelw, qggnllxsdc - ctyqcdpaeo) View more

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Biosimilar

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