Randomized Controlled Phase 2a Study of RPh201 in Previous Nonarteritic Anterior Ischemic Optic Neuropathy

Rath, Eitan Z.; Hazan, Zadik; Adamsky, Konstantin; Solomon, Arieh S.; Segal, Zvi; Levin, Leonard A.

doi:10.1097/wno.0000000000000786

Cited by 14 publications

(14 citation statements)

References 23 publications

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“…Results from the Phase 2a study were consistent with improvement in visual acuity in the RPh201 arm compared to placebo. 37 A phase 3 clinical trial is ongoing (NCT03547206).…”

Section: Discussionmentioning

confidence: 99%

A First‐in‐Human Phase 1 Randomized Single and Multiple Ascending Dose Study of RPh201 in Healthy Volunteers

Hazan

Adamsky

Lucassen

et al. 2019

Clinical Pharm in Drug Dev

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RPh201 is a drug extracted from gum mastic that has been studied for its anti‐inflammatory and antibacterial properties. Preclinical studies of RPh201 demonstrated neuroprotective and neuroenhancing effects. Toxicology studies in animals did not reveal safety concerns or genotoxic effects. This single‐center, phase 1, randomized, placebo‐controlled, double‐masked study in healthy volunteers assessed the safety and tolerability of RPh201, and determined the highest tolerated dose. There were 2 parts: a single ascending dose (SAD) stage, followed by a multiple ascending dose (MAD) stage. Three dosing arms were included in each stage (5 mg, 10 mg, and 20 mg). Safety data in the lower dosing arms were evaluated before higher doses were initiated. Eighteen participants were randomized in the SAD stage: 12 to RPh201 (4 at each dose) and 4 to placebo. Twenty‐one participants were randomized in the MAD stage, of which 13 received RPh201. All 18 participants in the SAD stage completed treatment. Sixteen of the 21 participants in the MAD stage completed treatment. The most frequently reported adverse events were local injection site pain and erythema. No deaths or adverse events related to changes in vital signs or electrocardiograms were reported. No occurrences of suicidal behavior or ideation were reported.

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“…Results from the Phase 2a study were consistent with improvement in visual acuity in the RPh201 arm compared to placebo. 37 A phase 3 clinical trial is ongoing (NCT03547206).…”

Section: Discussionmentioning

confidence: 99%

A First‐in‐Human Phase 1 Randomized Single and Multiple Ascending Dose Study of RPh201 in Healthy Volunteers

Hazan

Adamsky

Lucassen

et al. 2019

Clinical Pharm in Drug Dev

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“…The results of the phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT02045212) are already available. Patients showed an improvement in visual function after the treatment [294]. Dalfampridine is used to improve the walking ability in multiple sclerosis patients and is in a phase 4 clinical trial for non-arteritic ischemic optic neuropathy (ClinicalTrials.gov Identifier: NCT01975324).…”

Section: Clinical Trials Targeting Rgcs Neuroprotectionmentioning

confidence: 99%

Neuroprotective Strategies for Retinal Ganglion Cell Degeneration: Current Status and Challenges Ahead

Boia

Ruzafa

Aires

et al. 2020

IJMS

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The retinal ganglion cells (RGCs) are the output cells of the retina into the brain. In mammals, these cells are not able to regenerate their axons after optic nerve injury, leaving the patients with optic neuropathies with permanent visual loss. An effective RGCs-directed therapy could provide a beneficial effect to prevent the progression of the disease. Axonal injury leads to the functional loss of RGCs and subsequently induces neuronal death, and axonal regeneration would be essential to restore the neuronal connectivity, and to reestablish the function of the visual system. The manipulation of several intrinsic and extrinsic factors has been proposed in order to stimulate axonal regeneration and functional repairing of axonal connections in the visual pathway. However, there is a missing point in the process since, until now, there is no therapeutic strategy directed to promote axonal regeneration of RGCs as a therapeutic approach for optic neuropathies.

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“…As a result, improvement in visual acuity was reported in the RPh201 group compared to placebo. The phase 3 clinical trial is in recruiting status (NCT03547206) [134].…”

Section: Masticadienonic Acidmentioning

confidence: 99%

Pistacia Genus as a Potential Source of Neuroprotective Natural Products

et al. 2019

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Neuroprotective agents are able to defend the central nervous system against acute or chronic neuronal injuries. Even with the progress made over the last decades, most of the medications prescribed for the management of neurodegenerative diseases can only reduce their symptoms and slow down their progression. Based on natural product research, there are potential effective medicinal plants and phytochemicals for modulating neuronal functions and protecting against neurodegeneration. Plants in the genus Pistacia are also among valuable natural resources for neuroprotection research based on experiences in traditional medicine. Studies have supported the value of bioactive compounds of the genus Pistacia for central nervous system disorders such as Alzheimerʼs, Parkinsonʼs, multiple sclerosis, cerebral ischemia, depression, and anxiety. Related literature has also revealed that most of the evidence on neuroprotection in the genus Pistacia is in the form of preliminary studies, mainly including models of behavior, motor function, and memory impairments in animals, neural toxicity, cerebral ischemia and seizure models, evaluation of their effects on antioxidant and inflammatory biomarkers, amyloid β aggregation, and acetylcholinesterase as well as investigations into some cellular pathways. Along with the phytonutrients in kernels such as pistachios, various phytochemicals, mostly terpenes, and phenolic compounds have also been identified in different plant parts, in particular their oleoresins, of species in the genus Pistacia. In this review, the pharmacology of neurological effects and related molecular mechanisms of the plants belonging to the genus Pistacia and its active constituents, as well as pharmacokinetics aspects, are discussed.

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Randomized Controlled Phase 2a Study of RPh201 in Previous Nonarteritic Anterior Ischemic Optic Neuropathy

Cited by 14 publications

References 23 publications

A First‐in‐Human Phase 1 Randomized Single and Multiple Ascending Dose Study of RPh201 in Healthy Volunteers

A First‐in‐Human Phase 1 Randomized Single and Multiple Ascending Dose Study of RPh201 in Healthy Volunteers

Neuroprotective Strategies for Retinal Ganglion Cell Degeneration: Current Status and Challenges Ahead

Pistacia Genus as a Potential Source of Neuroprotective Natural Products

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