FirstString Research, Inc. is a clinical stage biotech firm that is dedicated to developing innovative drugs and medical applications based on cell-cell communication and cell-cell contact/adhesion science. The company holds an exclusive worldwide license from the Medical University of South Carolina (MUSC) for a portfolio of peptides that can modulate junctional proteins crucial for inter-cellular communication.

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Other Diseases

Eye Diseases

Skin and Musculoskeletal Diseases

Synthetic peptide

Recombinant polypeptide

Interleukins

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Nervous System Diseases	3
Endocrinology and Metabolic Disease	3

Top 5 Drug Type	Count

Synthetic peptide	2
Interleukins	1
Recombinant polypeptide	1

Top 5 Target	Count

TJP1(tight junction protein 1)	1
IL-6RA(Interleukin-6 receptor alpha subunit)	1

Drugs associated with Xequel Bio, Inc.

Zifogaptide

Target

TJP1

Mechanism

TJP1 inhibitors

Active Org.

Xequel Bio, Inc. [+1]

Originator Org.

Medical University of South Carolina

Active Indication

Cicatrix [+4]

Inactive Indication

Diabetic foot ulcer [+2]

Drug Highest PhasePhase 3

First Approval Ctry. / Loc.-

First Approval Date-

iNEXIN

Target-

Mechanism-

Active Org.

Xequel Bio, Inc.

Originator Org.

Xequel Bio, Inc.

Active Indication

Corneal Injuries [+3]

Inactive Indication

Dry Eye Syndromes

Drug Highest PhasePhase 2

First Approval Ctry. / Loc.-

First Approval Date-

Atexakin alfa

Target

IL-6RA

Mechanism

IL-6R agonists

Active Org.

RELIEF THERAPEUTICS Holding SA [+7]

Originator Org.

Merck Serono SA

Active Indication

Peripheral Nervous System Diseases [+2]

Inactive Indication

Peripheral Nerve Injuries

Drug Highest PhasePhase 2

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Xequel Bio, Inc.

NCT04684121 / WithdrawnPhase 2

A Phase 2, Prospective, Randomized, Double-Blind, Parallel-Group, Within-Subject Vehicle Controlled Multicenter Study of the Efficacy and Safety of Granexin® Gel to Improve Burn Wound Healing

To evaluate the efficacy of Granexin® gel to promote accelerated healing of second-degree (deep partial thickness) thermal burns.

Start Date01 Aug 2022

Sponsor / Collaborator

Xequel Bio, Inc.

[+1]

NCT05031806 / CompletedPhase 1

A Single-Center, Randomized, Double Masked, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of iNexin™ Eye Drops Compared to Vehicle in Subjects With Dry Eye Disease

The primary objective of this study is to evaluate the safety and tolerability of iNexin™ The secondary objective is to compare the efficacy of iNexin™ to Vehicle for the treatment of the signs and symptoms associated with dry eye disease.

Start Date28 Sep 2021

Sponsor / Collaborator

Xequel Bio, Inc.

[+1]

NCT04331080 / CompletedPhase 2/3

A Phase 2b/3 Randomized, Prospective, Double Blind, Within-Subject Vehicle Controlled, Multi-Center Study to Determine the Efficacy and Safety of Granexin® Gel in Reducing Scar Formation in Surgical Wounds Following Bilateral Anchor Incision Breast Surgery

The purpose of this study is to evaluate effectiveness of Granexin® gel in reducing scar formation in surgical incisional wounds.

Start Date01 Jul 2020

Sponsor / Collaborator

Xequel Bio, Inc.

100 Clinical Results associated with Xequel Bio, Inc.

0 Patents (Medical) associated with Xequel Bio, Inc.

Literatures (Medical) associated with Xequel Bio, Inc.

01 Nov 2022·Heliyon

Evaluation of a connexin-based peptide for the treatment of age-related macular degeneration

Article

Author: Grek, Christina ; Rohrer, Bärbel ; Obert, Elisabeth ; Ghatnekar, Gautam

A critical target in age-related macular degeneration (AMD) is the retinal pigment epithelium (RPE), which forms the outer blood-retina barrier (BRB). RPE-barrier dysfunction might result from the disruption of intercellular tight junctions (TJs). A Connexin43 (Cx43)-based peptide, aCT1, has been shown to prevent VEGF-induced loss of transepithelial resistance, choroidal neovascularization (CNV) and RPE-cell damage via the stabilization of TJs. Here, we probe the relative efficacies of aCT1 alone, anti-VEGF alone, and aCT1 with anti-VEGF in treating AMD pathologies. aCT1 monotherapy administered as topical eye drops with and without a VEGF blocking antibody administered systemically was tested in a mouse model of laser-induced CNV. The CNV mouse is the standard neovascular AMD model, reproducing hallmarks of its pathology. CNV lesion size and fluid accumulation were assessed using optical coherence tomography. During the angiogenesis phase of CNV lesion development, single applications of anti-VEGF or aCT1 reduced lesion and fluid dome size equally. The combinatorial aCT1/anti-VEGF strategy demonstrated lack of additive effects in this model. These data suggest that TJ stabilization by aCT1 is effective in ameliorating RPE dysfunction in a model of AMD-like angiogenesis, and that this strategy is as effective as the current clinical standard of care, anti-VEGF therapy. Critically, aCT1 holds potential as a new neovascular AMD treatment that can be administered using eye drops, which is preferable to the intravitreal injections required for standard anti-VEGF therapy.

01 May 2022·BRITISH JOURNAL OF DERMATOLOGY

HSP90 inhibitor RGRN-305 for oral treatment of plaque-type psoriasis: efficacy, safety and biomarker results in an open-label proof-of-concept study.

Article

Author: Litman, T ; Emmanuel, T ; Ghatnekar, G S ; Johansen, C ; Bregnhøj, A ; Thuesen, K K H ; Grek, C L ; Iversen, L

BACKGROUND:

HSP90 is a downstream regulator of tumour necrosis factor (TNF)-α and interleukin (IL)-17A signalling and may therefore serve as a novel target in the treatment of psoriasis.

OBJECTIVES:

This phase Ib proof-of-concept study was undertaken to evaluate the safety and efficacy of a novel HSP90 inhibitor (RGRN-305) in the treatment of plaque psoriasis.

METHODS:

We conducted an open-label, single-arm, dose-selection, single-centre proof-of-concept study. Patients with plaque psoriasis were treated with 250 mg or 500 mg RGRN-305 daily for 12 weeks. Efficacy was evaluated clinically using the Psoriasis Area and Severity Index (PASI), body surface area (BSA), Physician's Global Assessment (PGA) scores and the Dermatology Life Quality Index (DLQI). Skin biopsies collected at baseline and at 4, 8 and 12 weeks after initiation of treatment were used for immunohistochemical staining and for gene expression analysis. Safety was monitored via laboratory tests, vital signs, electrocardiogram and physical examinations.

RESULTS:

Six of the 11 patients who completed the study responded to RGRN-305 with a PASI improvement between 71% and 94%, whereas five patients were considered nonresponders with a PASI response < 50%. No severe adverse events were reported. Four of seven patients treated with 500 mg RGRN-305 daily experienced a mild-to-moderate exanthematous drug-induced eruption owing to the study treatment. Two patients chose to discontinue the study because of this exanthematous eruption. RGRN-305 treatment resulted in pronounced inhibition of the IL-23, TNF-α and IL-17A signalling pathways and normalization of both histological changes and psoriatic lesion gene expression profiles in patients who responded to treatment.

CONCLUSIONS:

Treatment with RGRN-305 showed acceptable safety, especially in the low-dose group, and was associated with clinically meaningful improvement in a subset of patients with plaque psoriasis, indicating that HSP90 may serve as a novel future target in psoriasis treatment.

01 Aug 2021·FASEB journal : official publication of the Federation of American Societies for Experimental BiologyQ2 · BIOLOGY

The connexin 43 carboxyl terminal mimetic peptide αCT1 prompts differentiation of a collagen scar matrix in humans resembling unwounded skin

Q2 · BIOLOGY

Article

Author: Grek, Christina L. ; Gourdie, Robert G. ; Rhett, J. Matthew ; Bustos, Francis ; Degen, Katherine ; Ghatnekar, Gautam S. ; Marsh, Spencer ; Jourdan, L. Jane ; Holmes, Jeffrey W. ; Montgomery, Jade ; Richardson, William J.

Phase II clinical trials have reported that acute treatment of surgical skin wounds with the therapeutic peptide alpha Connexin Carboxy-Terminus 1 (αCT1) improves cutaneous scar appearance by 47% 9-month postsurgery. While Cx43 and ZO-1 have been identified as molecular targets of αCT1, the mode-of-action of the peptide in scar mitigation at cellular and tissue levels remains to be further characterized. Scar histoarchitecture in αCT1 and vehicle-control treated skin wounds within the same patient were compared using biopsies from a Phase I clinical trial at 29-day postwounding. The sole effect on scar structure of a range of epidermal and dermal variables examined was that αCT1-treated scars had less alignment of collagen fibers relative to control wounds-a characteristic that resembles unwounded skin. The with-in subject effect of αCT1 on scar collagen order observed in Phase I testing in humans was recapitulated in Sprague-Dawley rats and the IAF hairless guinea pig. Transient increase in histologic collagen density in response to αCT1 was also observed in both animal models. Mouse NIH 3T3 fibroblasts and primary human dermal fibroblasts treated with αCT1 in vitro showed more rapid closure in scratch wound assays, with individual cells showing decreased directionality in movement. An agent-based computational model parameterized with fibroblast motility data predicted collagen alignments in simulated scars consistent with that observed experimentally in human and the animal models. In conclusion, αCT1 prompts decreased directionality of fibroblast movement and the generation of a 3D collagen matrix postwounding that is similar to unwounded skin-changes that correlate with long-term improvement in scar appearance.

News (Medical) associated with Xequel Bio, Inc.

08 May 2023

·www.globenewswire.com

Societal CDMO Selected by Xequel Bio to Provide CDMO Services to Support Ongoing Clinical Development of iNexin™

Activities Focused on Xequel’s Ophthalmic Solution Containing aCT1 Peptide, Being Developed for the Treatment of Persistent Corneal Epithelial Defect and Recurrent Corneal ErosionsSAN DIEGO and GAINESVILLE, Ga., May 08, 2023 (GLOBE NEWSWIRE) -- Societal CDMO, Inc. (“Societal CDMO”; NASD: SCTL), a contract development and manufacturing organization (CDMO), today announced that it has been selected by Xequel Bio, Inc. (“Xequel”) to provide CDMO services to support the ongoing clinical development of a patented new chemical entity based on its aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide) platform. The agreement spans a range of Societal CDMO’s offerings including process development and clinical trial services, culminating in cGMP manufacturing of the compound and placebo for upcoming Phase 2 clinical trials of iNexin™ (aCT1 ophthalmic solution). iNexin is a sterile, preservative-free ophthalmic solution containing aCT1 peptide that is currently being evaluated by Xequel for the potential treatment of persistent corneal epithelial defects (PCED). “We are pleased to have been selected by Xequel to continue our support of this important investigational drug candidate in the ophthalmology space. It is gratifying to be able to grow this relationship in lockstep with the advancement of iNexin into the next phase of its clinical development, demonstrating our ability to meet the evolving needs of our customers as they mature their development pipelines,” said David Enloe, chief executive officer of Societal CDMO. “This new agreement is the latest highlight in what has been an active period for our business development, project management, and operations teams. In just the past six weeks, we have announced new customer agreements with Longboard Pharmaceuticals and Xequel, project expansion agreements with several existing customers, and an approval from FDA for manufacturing of a commercial tablet at our Georgia facility. We continue to deliver against our growth strategy and look forward to maintaining the momentum as we move through 2023.” About Societal CDMOSocietal CDMO (NASDAQ: SCTL) is a bi-coastal contract development and manufacturing organization (CDMO) with capabilities spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms with a primary focus in the area of small molecules. With an expertise in solving complex manufacturing problems, Societal CDMO is a leading CDMO providing therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market. In addition to our experience in handling DEA controlled substances and developing and manufacturing modified-release dosage forms, Societal CDMO has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, which total 145,000 square feet, in Gainesville, Georgia and San Diego, California. Societal CDMO: Bringing Science to Society. For more information about Societal CDMO’s customer solutions, visit societalcdmo.com. About Xequel Bio, Inc.Xequel Bio, Inc. is a clinical stage biopharmaceutical company advancing its proprietary aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide) technology platform to develop drugs that will enable physicians to better manage a variety of indications involving inflammation and the body’s response to injury. aCT1 is a patented new chemical entity currently in development for multiple indications. Xequel’s lead clinical programs include Granexin® gel in dermatology and iNexin™ ophthalmic solution in ophthalmology. For more information, please visit www.xequel.com. Forward-Looking StatementsThis press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements, among other things, relate to the Company’s expectations regarding the completion of the proposed public offering, the Company’s use of proceeds from the proposed offering, and other statements. The words “anticipate”, “believe”, “could”, “estimate”, “upcoming”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “will” and similar terms and phrases may be used to identify forward-looking statements in this press release. Our operations involve risks and uncertainties, many of which are outside our control, and any one of which, or a combination of which, could materially affect our results of operations and whether the forward-looking statements ultimately prove to be correct. Factors that could cause the company’s actual outcomes to differ materially from those expressed in or underlying these forward-looking statements include risks and uncertainties associated with demand for the company’s services, which depends in part on customers’ research and development and the clinical plans and market success of their products; customers’ changing inventory requirements and manufacturing plans; customers and prospective customers decisions to move forward with the company’s manufacturing services; the average profitability, or mix, of the products the company manufactures; the company’s ability to enhance existing or introduce new services in a timely manner; fluctuations in the costs, availability, and suitability of the components of the products the company manufactures, including active pharmaceutical ingredients, excipients, purchased components and raw materials, or the company’s customers facing increasing or new competition. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results presented herein along with those risks and uncertainties discussed in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.

License out/inPhase 2

11 Jun 2021

·www.globenewswire.com

Corneal Ulcer Pipeline Analysis Demonstrates Novel Therapies at the Horizon Expected to Transform the Treatment Paradigm | DelveInsight

Los Angeles, June 10, 2021 (GLOBE NEWSWIRE) -- Corneal Ulcer Pipeline Analysis Demonstrates Novel Therapies at the Horizon Expected to Transform the Treatment Paradigm | DelveInsight The majority of the drugs for Corneal Ulcer are in the early stages of development and in coming years the market is expected to grow. DelveInsight’s ‘Corneal Ulcer Pipeline Insights’ report provides the current treatment landscape and rich analysis of pipeline therapies in different stages of development from pre-clinical till late-stage, along with dormant, inactive, and abandoned therapeutic agents. Some of the key pointers from the Corneal Ulcer Pipeline report: Discover more about the pharma company and therapy expected to grab maximum share by requesting sample report @ Corneal Ulcer Emerging Therapies and Forecast Corneal Ulcer: Overview Corneal Ulcer, also known as Keratitis, is characterized by damage or loss of the epithelial layer associated with infiltration of the underlying corneal stroma. Whilst the treatment of refractory corneal ulcers is challenging, it is essential that they are resolved as they can quickly endanger the anatomical integrity of the ocular surface or the transparency of the cornea. Discover more about disease outlook, available therapies, and emerging drugs, visit Corneal Ulcer Pipeline Analysis Corneal Ulcer Drug Pipeline Assessment Request for Sample to know more @ Corneal Ulcer Pipeline Analysis, Key Companies, and Futuristic Trends Corneal Ulcer Therapeutics Assessment The Corneal Ulcer Pipeline report lays down a comprehensive coverage of the active pipeline candidates segmented by Stage, Product Type, Route of Administration (RoA), Molecule Type, Target, and Mechanism of Action (MoA). By Product Type By Stage By Molecule Type By Route of Administration By Mechanism of Action By Targets Connect with our Business Executive for Asset Prioritization Services and Consulting Solutions Scope of the Corneal Ulcer Pipeline Report Coverage: GlobalKey Players: Recordati/Mime Tech, Oyster Point Pharma, Claris Biotherapeutics, Shanghai BDgene, Neuroptika, Provectus Biopharmaceuticals, OcuNexus Therapeutics, Santen S.A.S., FirstString Research, Regeneratetx, Stuart Therapeutics, EyeGate Pharmaceuticals, Trefoil Therapeutics, AmebaGone Inc., Dobecure, Editas medicine, and others. Key Corneal Ulcer Pipeline Therapies: REC 0559, OC01, CSB-001, BD-111, NRO-1, Rose bengal sodium, and others. Reach out @ Corneal Ulcer Pipeline: Novel therapies and Emerging technologies Table of Contents Learn more about the report offerings @ Corneal Ulcer Emerging Therapies, Treatments and Ongoing Clinical Trials Related ReportsCorneal Ulcer MarketDelveInsight's "Corneal Ulcer - Market Insights, Epidemiology, and Market Forecast-2030" report.Peptic Ulcer Hemorrhage MarketDelveInsight's "Peptic Ulcer Hemorrhage - Market Insights, Epidemiology, and Market Forecast-2030" report.Varicose Ulcer MarketDelveInsight's " Varicose Ulcer - Market Insights, Epidemiology, and Market Forecast-2030" report. Venous Leg Ulcer MarketDelveInsight's "Venous Leg Ulcer - Market Insights, Epidemiology, and Market Forecast-2030" report. Related Posts Global Burden of Cytomegalovirus SeroprevalenceAnalysis of therapies and key companies such as Merck, Helocyte, Shire, Atara Biotherapeutics, ViraCyte, and others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end 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

100 Deals associated with Xequel Bio, Inc.

100 Translational Medicine associated with Xequel Bio, Inc.

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Pipeline Snapshot as of 22 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Preclinical

Phase 2

Phase 3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Atexakin alfa ( IL-6RA )	Diabetic Neuropathies More	Phase 2
Aerosolized aCT1	Acute Lung Injury More	Preclinical
Zifogaptide ( TJP1 )	Diabetic foot ulcer More	Discontinued
ACT-3	Neoplasms More	Discontinued
ACT-2	Wounds and Injuries More	Discontinued

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