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March 9, 2022 / eMedClub PR News / -- Urovant Sciences, a clinical-stage biopharmaceutical company focused on developing treatments to improve urinary conditions, announced today that its first gene therapy, URO, for the treatment of overactive bladder (OAB) Phase 2a trials of -902 yielded positive results
.
OAB is a syndrome characterized by urinary urgency, often accompanied by symptoms of frequent urination and nocturia, which may lead to urge urinary incontinence (UUI).
Its prevalence is high and increases significantly with age.
high
.
In the United States, more than 30 million people over the age of 40 suffer from OAB symptoms
.
With the acceleration of the aging process of China's population, the number of people suffering from this symptom is also increasing year by year
.
OAB symptoms can cause anxiety and depression, and have a negative impact on the patient's physical and mental health and quality of life.
It is a hidden "social cancer"
.
URO-902, developed by Urovant, is a novel gene therapy based on a "naked" DNA plasmid for patients with OAB who have failed oral drug therapy
.
For patients with OAB symptoms and UUI, URO-902 was injected directly into the bladder wall under local anesthesia
.
The Phase 2a trial in 80 female patients was designed to evaluate the efficacy, safety and tolerability of single-administration doses of 24 mg and 48 mg of URO-902 compared to placebo
.
Results showed clinically meaningful and statistically significant improvements in a number of relevant measures of OAB, including urination frequency, emergent events, and quality of life, with URO-902 compared to placebo at week 12 post-dose
.
In addition, URO-902 was well tolerated, and the most common adverse event in both treatment groups was urinary tract infection
.
"These promising results demonstrate that URO-902 may offer a new treatment option for patients with overactive bladder who have not responded well to oral medications," said lead investigator and chief of urology at Royal Oak Beaumont Hospital, Dr.
Kenneth Peters
.
The company plans to present top-line results from the trial at the annual meeting of the American Urological Association in New Orleans, Louisiana, May 13-16, 2022
.
OAB ushered in a new era of gene therapy OAB is considered to be a smooth muscle disease of the genitourinary system, and by regulating smooth muscle tension, the organs with high tension can be relaxed to achieve therapeutic purposes
.
In 2018, the OAB therapeutic field welcomed Mirabegron Extended-Release Tablets (Betantril®), which selectively stimulates the β-3 adrenergic receptors in the bladder, relaxes the detrusor, increases urine storage capacity and urination The interval, while not affecting bladder emptying, avoids the risk of urinary retention
.
In 2019, the updated OAB diagnosis and treatment guidelines of the Chinese Medical Association Urology Branch (CUA) included β-3 receptor agonists as first-line drugs for OAB treatment for the first time
.
In December 2020, Urovant's lead product GEMTSA (vibegron) (an oral small molecule beta-3 agonist) was approved by the US FDA and launched in the US in April 2021, becoming the first FDA-approved product since 2012.
It is a new OAB prescription drug and the company's first FDA-approved innovative drug
.
▲ R&D pipeline (Image source: Urovant official website) In August 2018, Urovant obtained the global development and promotion authorization of hMaxi-K, an investigational gene therapy for the treatment of OAB, from Ion Channel Innovations (ICI)
.
hMaxi-K is a "naked" DNA plasmid that carries the cDNA of the human hSlo gene, which encodes the alpha subunit of the smooth muscle high conductance potassium (Maxi-K) channel
.
The Maxi-K channel is a 4-mer formed by 2 alpha subunits and 2 beta subunits, where the alpha subunit forms the channel pore through which potassium ions can pass through the cytoplasmic membrane, and the beta subunit regulates potassium ions in and out in response to intracellular calcium levels
.
Preclinical studies have shown that expressing a channel composed of only α subunits can achieve cell membrane hyperpolarization, reduce smooth muscle cell tension, and have physiological effects of organ relaxation
.
The "naked" DNA plasmid can be absorbed into the nucleus of smooth muscle cells, and then a large number of Maxi-K potassium channels are synthesized on the smooth muscle cell membrane
.
ICI completed a Phase 1b trial involving 13 patients in 2017
.
Trial results showed dose-dependent improvement in symptoms of urgency and frequency, reaching statistical significance in the high-dose group (p<0.
05), and hMaxi-K was generally well tolerated
.
▲ When Maxi-K channels open, it results in hyperpolarization of the cell membrane, a reduction in calcium influx and a reduction in smooth muscle cell tone (Image source: Reference 3) Currently, there is no FDA-approved gene therapy for the treatment of OAB , URO-902 is expected to be the first
.
If approved, this innovative therapy may address an unmet need for patients who have failed oral drug therapy and are concerned that other minimally invasive therapies or surgical interventions associated with existing third-line OAB treatments may contribute to urinary retention
.
References: 1.
https:// -uro-902/2.
https://urovant.
com/science#section__product-pipeline3.
https:// Statement: The contents of this article are only for exploring the frontier progress of biomedicine and do not constitute a If you need any medical advice, please go to a regular hospital for treatment
.
.
OAB is a syndrome characterized by urinary urgency, often accompanied by symptoms of frequent urination and nocturia, which may lead to urge urinary incontinence (UUI).
Its prevalence is high and increases significantly with age.
high
.
In the United States, more than 30 million people over the age of 40 suffer from OAB symptoms
.
With the acceleration of the aging process of China's population, the number of people suffering from this symptom is also increasing year by year
.
OAB symptoms can cause anxiety and depression, and have a negative impact on the patient's physical and mental health and quality of life.
It is a hidden "social cancer"
.
URO-902, developed by Urovant, is a novel gene therapy based on a "naked" DNA plasmid for patients with OAB who have failed oral drug therapy
.
For patients with OAB symptoms and UUI, URO-902 was injected directly into the bladder wall under local anesthesia
.
The Phase 2a trial in 80 female patients was designed to evaluate the efficacy, safety and tolerability of single-administration doses of 24 mg and 48 mg of URO-902 compared to placebo
.
Results showed clinically meaningful and statistically significant improvements in a number of relevant measures of OAB, including urination frequency, emergent events, and quality of life, with URO-902 compared to placebo at week 12 post-dose
.
In addition, URO-902 was well tolerated, and the most common adverse event in both treatment groups was urinary tract infection
.
"These promising results demonstrate that URO-902 may offer a new treatment option for patients with overactive bladder who have not responded well to oral medications," said lead investigator and chief of urology at Royal Oak Beaumont Hospital, Dr.
Kenneth Peters
.
The company plans to present top-line results from the trial at the annual meeting of the American Urological Association in New Orleans, Louisiana, May 13-16, 2022
.
OAB ushered in a new era of gene therapy OAB is considered to be a smooth muscle disease of the genitourinary system, and by regulating smooth muscle tension, the organs with high tension can be relaxed to achieve therapeutic purposes
.
In 2018, the OAB therapeutic field welcomed Mirabegron Extended-Release Tablets (Betantril®), which selectively stimulates the β-3 adrenergic receptors in the bladder, relaxes the detrusor, increases urine storage capacity and urination The interval, while not affecting bladder emptying, avoids the risk of urinary retention
.
In 2019, the updated OAB diagnosis and treatment guidelines of the Chinese Medical Association Urology Branch (CUA) included β-3 receptor agonists as first-line drugs for OAB treatment for the first time
.
In December 2020, Urovant's lead product GEMTSA (vibegron) (an oral small molecule beta-3 agonist) was approved by the US FDA and launched in the US in April 2021, becoming the first FDA-approved product since 2012.
It is a new OAB prescription drug and the company's first FDA-approved innovative drug
.
▲ R&D pipeline (Image source: Urovant official website) In August 2018, Urovant obtained the global development and promotion authorization of hMaxi-K, an investigational gene therapy for the treatment of OAB, from Ion Channel Innovations (ICI)
.
hMaxi-K is a "naked" DNA plasmid that carries the cDNA of the human hSlo gene, which encodes the alpha subunit of the smooth muscle high conductance potassium (Maxi-K) channel
.
The Maxi-K channel is a 4-mer formed by 2 alpha subunits and 2 beta subunits, where the alpha subunit forms the channel pore through which potassium ions can pass through the cytoplasmic membrane, and the beta subunit regulates potassium ions in and out in response to intracellular calcium levels
.
Preclinical studies have shown that expressing a channel composed of only α subunits can achieve cell membrane hyperpolarization, reduce smooth muscle cell tension, and have physiological effects of organ relaxation
.
The "naked" DNA plasmid can be absorbed into the nucleus of smooth muscle cells, and then a large number of Maxi-K potassium channels are synthesized on the smooth muscle cell membrane
.
ICI completed a Phase 1b trial involving 13 patients in 2017
.
Trial results showed dose-dependent improvement in symptoms of urgency and frequency, reaching statistical significance in the high-dose group (p<0.
05), and hMaxi-K was generally well tolerated
.
▲ When Maxi-K channels open, it results in hyperpolarization of the cell membrane, a reduction in calcium influx and a reduction in smooth muscle cell tone (Image source: Reference 3) Currently, there is no FDA-approved gene therapy for the treatment of OAB , URO-902 is expected to be the first
.
If approved, this innovative therapy may address an unmet need for patients who have failed oral drug therapy and are concerned that other minimally invasive therapies or surgical interventions associated with existing third-line OAB treatments may contribute to urinary retention
.
References: 1.
https:// -uro-902/2.
https://urovant.
com/science#section__product-pipeline3.
https:// Statement: The contents of this article are only for exploring the frontier progress of biomedicine and do not constitute a If you need any medical advice, please go to a regular hospital for treatment
.
