A Phase 2a Study to Evaluate Safety and Tolerability After Single Administration of PER-001 Intravitreal Implant in Participants with Diabetic Retinopathy

This is a Phase 2a, randomized, single-masked (participant), sham controlled clinical study.

Start Date05 Aug 2023

Sponsor / Collaborator

Perfuse Therapeutics, Inc.Startup

NCT05822245 / Active, not recruitingPhase 1/2

A Phase 1/2a Study to Evaluate Safety, Tolerability, and Pharmacodynamic Effect After Single Administration of PER-001 Intravitreal Implant in Participants with Open-Angle Glaucoma

This clinical study has two phases: Phase 1 and Phase 2a. Phase 1 is an open-label, single ascending dose (SAD), while Phase 2a is a randomized, single-masked (participant) with a sham control.

Start Date25 May 2023

Sponsor / Collaborator

Perfuse Therapeutics, Inc.Startup

100 Clinical Results associated with PER-001

100 Translational Medicine associated with PER-001

100 Patents (Medical) associated with PER-001

Literatures (Medical) associated with PER-001

12 Jun 2019·Endocrine, Metabolic & Immune Disorders - Drug Targets

Prevalence of Extended-Spectrum β-Lactamases in Multi-drug ResistantPseudomonas aeruginosafrom Diabetic Foot Patients

Article

Author: Sehgal, Sheikh Arslan ; Khan, Momin ; Ul Hassan, Faaiz ; Mumtaz, Shahina ; Ul Haq, Khayam ; Siraj, Sami ; Arshad, Muhammad ; Qudus, Muhammad Suhaib ; Ahmed, Jawad

Introduction:Pseudomonas aeruginosa is one of the major pathogens associated with the acute tissue damage in patients having Diabetic Foot Ulcer (DFU). The treatment of such infections can be an uphill battle due to the serious resistance to all the mainstay antibiotics, owing to overzealous production of Extended-Spectrum Beta-Lactamases (ESBLs). Pakistan also has a high prevalence of diabetes and complications related to it, however genetic disposition of the pathogens remains underinvestigated.Aim:The main objective of the study was to determine the frequency of ESBLs in Multi-drug resistant P. aeruginosa from diabetic foot patients.Methods:The duration of the present study was one year and 100 patients having DFU were enrolled. All the pus samples were subjected to the bacterial culture, gram staining, catalase test, oxidase test and antimicrobial susceptibility pattern to various antibiotics for the confirmation of P. aeruginosa. Of 23 positive isolates of P. aeruginosa, 10 were ESBLs positive as detected by double disk diffusion test. The positive ESBL strain shows an increase of ≥5mm in the zone of inhibition of the combination discs in comparison to the alone ceftazidime disc.Results:The ESBLs positive strains were also tested for TEM-1, SHV-1, PER-1, and VEB-1, where: (07/10) strains carried SHV-1, (05/10) strains were positive for TEM-1, while none of the isolates were PCR-positive for PER-1 and VEB-1.Conclusion:The findings of the current study show a difference in the pattern of ESBL genes compared to that of other such endeavors. The present study also warrants the PCR-based detection of the type of ESBL as a potential factor to consider in deciding the therapeutic strategy at any point during the treatment.

01 Dec 1998·Journal of Hospital InfectionQ3 · MEDICINE

An outbreak of extended-spectrum, β-lactamase-producing Salmonella senftenberg in a burns ward

Q3 · MEDICINE

Review

Author: P.D. Stapleton ; G. Revathi ; B.K. Jain ; G.L French ; K.P. Shannon

A strain of Salmonella senftenberg resistant to ceftazidime, gentamicin, chloramphenicol and ciprofloxacin was isolated from burn wounds of eight patients on a burns ward of a hospital in Delhi, India. The organism, which had probably been spread from patient to patient on staff hands, produced the extended-spectrum beta-lactamase SHV-5 and the aminoglycoside-modifying enzymes AAC(3)II + AAC(6'). The strain was not isolated from stool cultures of any of the patients or staff, apart from the index patient who had a history of diarrhoea and fever before admission. The outbreak ended in three weeks, after the implementation of strict handwashing. This is the first report of SHV-5 beta-lactamase in Salmonella spp. and also the first report of SHV-5 in India. The extended-spectrum beta-lactamases that have been reported in Salmonella spp. now include the Group 2 be enzymes SHV-2, SHV-5, TEM-3, TEM-25, TEM-27, CTX-M2, PER-1 and PER-2, and the Group 1 enzymes DHA-1 and CMY-2. The types of extended-spectrum beta-lactamases produced by salmonellas, their association with aminoglycoside resistance and their geographical distribution are now similar to those seen in klebsiella. Increasing antibiotic resistance in these organisms is reducing therapeutic options for the treatment of invasive disease.

01 Mar 1974·Molecular and General Genetics MGG

A perithecial color mutant of Neurospora crassa

Article

Author: Ernest W. Benson ; H. Branch Howe

A mutation, per-1, was found in N. crassa which caused orange instead of black perithecia when the protoperithecial parent contained the per-1 allele. No effect of per-1 was found on vegetative morphology or nutritional requirements. The per-1 locus was mapped proximal to iv (?6201) in the right arm of linkage group V.

News (Medical) associated with PER-001

03 Aug 2023

·www.prnewswire.com

Perfuse Therapeutics Announces Initiation of Enrollment to the Phase 2A Clinical Trial of PER001 Intravitreal Implant in Diabetic Retinopathy

SAN FRANCISCO, Aug. 3, 2023 /PRNewswire/ -- Perfuse Therapeutics, a biopharmaceutical company pioneering transformational therapies to treat ischemia-induced ocular diseases is pleased to announce the initiation of enrollment into the Ph2a clinical trial of PER-001 intravitreal implant in Diabetic Retinopathy. The Phase 2a trial is a patient masked, randomized, sham-controlled study that will evaluate the safety and tolerability of two doses of PER-001 Intravitreal Implant in patients with Diabetic Retinopathy. The Company is also evaluating PER-001 intravitreal implant in a Ph1/2a clinical trial in patients with Glaucoma. "The initiation of this trial is a significant milestone for patients, the retina community and Perfuse, as we continue to advance in the clinic with a potentially disease-modifying treatment for diabetic retinopathy. Rapid advancement into multiple Ph2a studies is a testament to the skill and dedication of our team and underscores the broad potential of our intravitreal sustained release PER-001 implant in all retinal diseases driven by ischemia", said Sevgi Gurkan, M.D., Founder and CEO of Perfuse. PER-001 is a first-in-class small molecule in a sustained release proprietary delivery platform that selectively targets inhibition of the endothelin pathway. Endothelin is the most potent vasoconstrictor in the human body and is a key regulator of vascular tone. Endothelin signaling is also involved in inflammation and cell death through its receptors expressed in vascular and non-vascular neuroretinal cells. Many studies have demonstrated that the endothelin pathway is upregulated in a wide range of ocular diseases, including diabetic retinopathy, glaucoma, age-related macular degeneration, and retinal vein occlusion. "Pathologic endothelin signaling in diabetes leads to microvascular complications and ischemia in many tissues, including the retina. Current therapies for diabetic retinopathy do not address the underlying ischemic vascular disease and the absence of a safe and effective treatment of ischemia in the retina represents a significant unmet medical need. In multiple preclinical models, treatment with PER-001 has demonstrated potent and selective inhibition of endothelin signaling, leading to improved retinal blood flow and hypoxia as well as reduction in neovascularization." said Phil Lai, M.D., Chief Medical Officer of Perfuse. About PER-001 Intravitreal Implant PER-001 is a novel (NCE), first-in-class small molecule endothelin receptor antagonist. The PER-001 intravitreal implant is a 4 mm, bio-erodible cylindrical implant, administered into the vitreous cavity of the eye using a single use, 25-gauge applicator and designed to provide a sustained release of PER-001 for 6 months. About Perfuse Therapeutics, Inc. Perfuse Therapeutics is a clinical-stage biotechnology company pioneering first-in-class therapies to treat ischemia-mediated ocular diseases. Enabled by its proprietary molecules and sustained release drug delivery platform, the company is developing a robust pipeline of novel assets against validated targets. Headquartered in San Francisco, California and with R&D facilities in North Carolina, Perfuse Therapeutics has established a strong team committed to advancing disease modifying therapies to patients with ocular diseases around the world. More information on Perfuse can be found at and on LinkedIn. Investor Relations and Media Contact Please contact us for more information or questions at – [email protected].com SOURCE Perfuse Therapeutics

Phase 2

20 Jul 2023

·www.prnewswire.com

Perfuse Therapeutics Announces Initiation of Enrollment to Ph2a portion of the Phase 1/2a Clinical Trial of PER-001 Intravitreal Implant in Patients with Glaucoma

SAN FRANCISCO, July 20, 2023 /PRNewswire/ -- Perfuse Therapeutics, a biopharmaceutical company pioneering transformational therapies to treat ischemia-induced ocular diseases is pleased to announce the successful clearance of Phase 1 safety for the low dose PER-001 intravitreal implant. This significant milestone allows the initiation of enrollment to the Ph2a portion of the Phase 1/2a clinical study of PER-001 intravitreal implant in patients with glaucoma. The low-dose cohort in the first-in human, single-arm, open label, Phase 1 portion of the study evaluating the safety and tolerability of PER-001 intravitreal implant in patients with advanced glaucoma is fully enrolled. To date, the low-dose PER-001 intravitreal implant has been found to be safe and well-tolerated allowing the advancement to the Ph2a portion of this study. The Phase 2a trial is a patient masked, randomized, sham-controlled study that will evaluate the safety, tolerability, and pharmacodynamics of two doses of PER-001 in patients with progressing glaucoma starting with the low-dose. PER-001 is a first-in-class small molecule in a sustained release proprietary delivery platform that selectively targets inhibition of the endothelin pathway. Endothelin is the most potent vasoconstrictor in the human body and is a key regulator of vascular tone. Endothelin signaling is also involved in inflammation and cell death through its receptors expressed in vascular and non-vascular cells. Many studies have demonstrated that the endothelin pathway is upregulated in a wide range of ocular diseases, including glaucoma, diabetic retinopathy, age-related macular degeneration and retinal vein occlusion. "Multiple lines of evidence implicate vascular dysregulation as a driver of glaucomatous disease progression and that excess endothelin levels play a key role in reducing ocular blood flow. Preclinical studies of PER-001 in relevant disease models, including the non-human primate model of glaucoma, have demonstrated potent and selective inhibition of endothelin signaling, with resultant increase in optic nerve head blood flow (presented at 2022 ARVO Meeting) as well as neuroprotective effects on the retinal ganglion cells", said Phil Lai, MD, Chief Medical Officer of Perfuse Therapeutics. "We are excited that the safety data supports evaluation of the low dose PER-001 intravitreal implant in the Phase 2a portion of the trial in patients with progressing glaucoma." "The initiation of the Phase 2a clinical trial is a significant milestone for both Perfuse and the glaucoma community as we continue to advance in the clinic with a novel, IOP-independent treatment for glaucoma" said Sevgi Gurkan, MD CEO and Founder of Perfuse Therapeutics. "The absence of a safe and effective treatment of ischemia in the retina represents a significant unmet medical need and we plan to evaluate PER-001 intravitreal implant in other retinal diseases driven by ischemia including diabetic retinopathy, dry age-related macular degeneration and retinal vein occlusion." About PER-001 Intravitreal Implant PER-001 is a novel (NCE), first-in-class small molecule endothelin receptor antagonist. The PER-001 intravitreal implant is a 4 mm, bio-erodible cylindrical implant, administered into the vitreous cavity of the eye using a single use, 25-gauge applicator and designed to provide a sustained release of PER-001 for 6 months. About Perfuse Therapeutics, Inc. Perfuse Therapeutics is a clinical-stage biotechnology company pioneering first-in-class therapies to treat ischemia-mediated ocular diseases. Enabled by its proprietary molecules and sustained release drug delivery platform, the company is developing a robust pipeline of novel assets against validated targets. Headquartered in San Francisco, California and with R&D facilities in North Carolina, Perfuse Therapeutics has established a strong team committed to advancing disease modifying therapies to patients with ocular diseases around the world. More information on Perfuse can be found at and on LinkedIn. Investor Relations and Media Contact – [email protected]com SOURCE Perfuse Therapeutics

Phase 2Phase 1

05 Apr 2023

·www.nsmedicaldevices.com

Perfuse Therapeutics Announces FDA Clearance of IND Application for Phase 1/2a Clinical Trial of PER-001 Intravitreal Implant in Patients with Glaucoma

This milestone marks transition of Perfuse Therapeutics to a clinical-stage company PER-001 is a first-in-class small molecule in a sustained release proprietary delivery platform that selectively targets inhibition of the endothelin pathway. (Credit: Ion Fet on Unsplash) Perfuse Therapeutics, a biopharmaceutical company pioneering transformational therapies to treat ischemia-induced ocular diseases announced today that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for a Phase 1/2a clinical study of PER-001 Intravitreal Implant in patients with glaucoma. The first-in human single-arm, open label, Phase 1 portion of the study will evaluate the safety and tolerability of PER-001 Intravitreal Implant in patients with advanced glaucoma. The Phase 2a trial, is a patient masked, randomized, sham-controlled study that will evaluate the safety, tolerability, and pharmacodynamics of two doses of PER-001 in patients with progressing glaucoma. “The initiation of this Ph1/2a clinical trial is a significant milestone for both Perfuse and the glaucoma community as we advance into the clinic with a novel, IOP-independent treatment for glaucoma” said Sevgi Gurkan, MD, CEO and Founder of Perfuse Therapeutics. “The absence of a safe and effective treatment of ischemia in the retina represents a significant unmet medical need and we plan to evaluate PER-001 Intravitreal Implant in other retinal diseases driven by ischemia including diabetic retinopathy, dry age-related macular degeneration and retinal vein occlusion.” PER-001 is a first-in-class small molecule in a sustained release proprietary delivery platform that selectively targets inhibition of the endothelin pathway. Endothelin is the most potent vasoconstrictor in the human body and is a key regulator of vascular tone. Endothelin signaling is also involved in inflammation and cell death through its receptors expressed in vascular and non-vascular cells. Many studies have demonstrated that the endothelin pathway is upregulated in a wide range of ocular diseases, including glaucoma, diabetic retinopathy, age-related macular degeneration and retinal vein occlusion. “Multiple lines of evidence implicate vascular dysregulation as a driver of glaucomatous disease progression and that excess endothelin levels play a key role in reducing ocular blood flow. Preclinical studies of PER-001 in relevant disease models, including the non-human primate model of glaucoma, have demonstrated potent and selective inhibition of endothelin signaling, with resultant increase in optic nerve head blood flow (presented at 2022 ARVO Meeting) as well as neuroprotective effects on the retinal ganglion cells”, said Phil Lai, MD, Chief Medical Officer of Perfuse Therapeutics. “We are excited to evaluate the PER-001 Intravitreal Implant in the Phase 1/2a trial.” Source: Company Press Release

Phase 2IND

100 Deals associated with PER-001

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic Retinopathy	Phase 2	US	Perfuse Therapeutics, Inc.Startup	05 Aug 2023
Glaucoma, Open-Angle	Phase 2	US	Perfuse Therapeutics, Inc.Startup	25 May 2023
dry age-related macular degeneration	Discovery	US	Perfuse Therapeutics, Inc.Startup	18 Jul 2024
Geographic Atrophy	Discovery	US	Perfuse Therapeutics, Inc.Startup	18 Jul 2024
Retinal Vein Occlusion	Discovery	US	Perfuse Therapeutics, Inc.Startup	18 Jul 2024

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