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According to foreign media reports, the South African Food and Drug Administration has recently approved a clinical study of the use of suramin sodium in the treatment of new crown sequelae, and patients will be recruited from the first quarter of this year
.
The study was filed by a biopharmaceutical company called PaxMedica
.
On January 7, 2022, the company announced that PAX-101 (suramin sodium for injection) was approved by the South African Medicines Regulatory Authority (SAHPRA) to study the therapeutic effect of patients with new crown sequelae (LCS, Long Covid Syndrome)
.
LCS is a serious multisystem disease that can lead to severe impairment of function in patients
.
The Phase 1B study, named PAX-LCS-101, will be a randomized, controlled, double-blind, multi-dose group prospective manner, specifically targeting physical and neuropsychiatric symptoms lasting more than 12 weeks after infection with the new coronavirus
.
Diagnosis of LCS is challenging because no specific test is used to confirm the diagnosis
.
Although many definitions have been proposed in the medical literature, most researchers define LCS as a syndrome that includes physical and neuropsychiatric symptoms lasting more than 12 weeks without other etiologies
.
Symptoms of LCS may vary from patient to patient, but typically include fatigue, short-circuiting of the brain, body aches, headache, shortness of breath, difficulty concentrating, sleep disturbance, orthostatic dizziness, joint and muscle pain, depression and anxiety, and many related symptoms
.
The currently observed LCS is highly similar to the symptoms known as Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS), including physical fatigue and other similar symptoms
.
In addition, both disorders can prevent work or normal activities
.
In the extreme case of ME/CFS, according to past data, affected individuals are confined to their homes even if they are not bedridden
.
PaxMedica plans to use suramin sodium as a treatment for LCS and ME/CFS
.
"People with LCS and ME/CFS have nearly identical physical symptoms and similar pathophysiology related to mitochondrial and purinergic signaling
.
Suramin, as a purinergic receptor antagonist, may play a role in addressing Both diseases play an important role in the syndrome,
"
commented Robert K.
Naviaux, MD, co-director of the Center for Mitochondrial and Metabolic Diseases at the University of California at San Diego School of Medicine
.
A clinical trial is planned to investigate the safety, tolerability, efficacy and in vivo dynamics of the drug in two doses of suramin sodium (5mg/kg and 10mg/kg) in adults 18 years and older with LCS
.
There is clearly an unmet medical need for LCS, but there are currently no approved drugs to treat the disease
.
There is a growing consensus in the scientific and medical communities that more research is needed on the causes of LCS and potentially related ME/CFS
.
PAX-101 Suramin sodium for injection in the treatment of autism spectrum disorder (ASD, Autism Spectrum Disorder) is in Phase II
.
Additionally, the company is developing PAX-102 as a suramin sodium nasal drop for ASD and other neurological disorders
.
PaxMedica is a clinical-stage pharmaceutical company leading the development of PAX-101 to advance its use in ASD, ME/CFS, LCS and Fragile X-related tremor/ataxia syndrome
.
Although ASD is common in many communities, no FDA-approved treatment for its core symptoms exists
.
PaxMedica's most advanced clinical treatment, PAX-101, is currently being evaluated in clinical trials to support the treatment of core and related symptoms in children with ASD
.
Naviaux studies using suramin sodium for the treatment of autism for decades have achieved statistical significance in two animal models of ASD and a small clinical trial [1,2,3]
.
In order to further reveal the pharmacodynamic mechanism, Naviaux also measured the time series of various biomarkers [4]
.
Naviaux believes that purinergic antagonist therapy (typically suramin sodium) is the underlying logic to solve a class of neurological diseases (typically ASD), which is why he believes that suramin sodium has the potential to treat the sequelae of the new crown
.
References [1]Naviaux, Robert K.
, et al.
"Antipurinergic therapy corrects the autism-like features in the poly (IC) mouse model.
" PloS one 8.
3 (2013): e57380.
[2]Naviaux, Jane C.
, et al.
"Antipurinergic therapy corrects the autism-like features in the Fragile X (Fmr1 knockout) mouse model.
" Molecular autism 6.
1 (2015): 1-20.
[3]Naviaux, Robert K.
, et al.
"Low ‐dose suramin in autism spectrum disorder: a small, phase I/II, randomized clinical trial.
" Annals of clinical and translational neurology 4.
7 (2017): 491-505.
[4]Zolkipli-Cunningham, Zarazuela, et al.
"Metabolic and behavioral features of acute hyperpurinergia and the maternal immune activation mouse model of autism spectrum disorder.
" PloS one 16.
3 (2021): e0248771
.
The study was filed by a biopharmaceutical company called PaxMedica
.
On January 7, 2022, the company announced that PAX-101 (suramin sodium for injection) was approved by the South African Medicines Regulatory Authority (SAHPRA) to study the therapeutic effect of patients with new crown sequelae (LCS, Long Covid Syndrome)
.
LCS is a serious multisystem disease that can lead to severe impairment of function in patients
.
The Phase 1B study, named PAX-LCS-101, will be a randomized, controlled, double-blind, multi-dose group prospective manner, specifically targeting physical and neuropsychiatric symptoms lasting more than 12 weeks after infection with the new coronavirus
.
Diagnosis of LCS is challenging because no specific test is used to confirm the diagnosis
.
Although many definitions have been proposed in the medical literature, most researchers define LCS as a syndrome that includes physical and neuropsychiatric symptoms lasting more than 12 weeks without other etiologies
.
Symptoms of LCS may vary from patient to patient, but typically include fatigue, short-circuiting of the brain, body aches, headache, shortness of breath, difficulty concentrating, sleep disturbance, orthostatic dizziness, joint and muscle pain, depression and anxiety, and many related symptoms
.
The currently observed LCS is highly similar to the symptoms known as Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS), including physical fatigue and other similar symptoms
.
In addition, both disorders can prevent work or normal activities
.
In the extreme case of ME/CFS, according to past data, affected individuals are confined to their homes even if they are not bedridden
.
PaxMedica plans to use suramin sodium as a treatment for LCS and ME/CFS
.
"People with LCS and ME/CFS have nearly identical physical symptoms and similar pathophysiology related to mitochondrial and purinergic signaling
.
Suramin, as a purinergic receptor antagonist, may play a role in addressing Both diseases play an important role in the syndrome,
"
commented Robert K.
Naviaux, MD, co-director of the Center for Mitochondrial and Metabolic Diseases at the University of California at San Diego School of Medicine
.
A clinical trial is planned to investigate the safety, tolerability, efficacy and in vivo dynamics of the drug in two doses of suramin sodium (5mg/kg and 10mg/kg) in adults 18 years and older with LCS
.
There is clearly an unmet medical need for LCS, but there are currently no approved drugs to treat the disease
.
There is a growing consensus in the scientific and medical communities that more research is needed on the causes of LCS and potentially related ME/CFS
.
PAX-101 Suramin sodium for injection in the treatment of autism spectrum disorder (ASD, Autism Spectrum Disorder) is in Phase II
.
Additionally, the company is developing PAX-102 as a suramin sodium nasal drop for ASD and other neurological disorders
.
PaxMedica is a clinical-stage pharmaceutical company leading the development of PAX-101 to advance its use in ASD, ME/CFS, LCS and Fragile X-related tremor/ataxia syndrome
.
Although ASD is common in many communities, no FDA-approved treatment for its core symptoms exists
.
PaxMedica's most advanced clinical treatment, PAX-101, is currently being evaluated in clinical trials to support the treatment of core and related symptoms in children with ASD
.
Naviaux studies using suramin sodium for the treatment of autism for decades have achieved statistical significance in two animal models of ASD and a small clinical trial [1,2,3]
.
In order to further reveal the pharmacodynamic mechanism, Naviaux also measured the time series of various biomarkers [4]
.
Naviaux believes that purinergic antagonist therapy (typically suramin sodium) is the underlying logic to solve a class of neurological diseases (typically ASD), which is why he believes that suramin sodium has the potential to treat the sequelae of the new crown
.
References [1]Naviaux, Robert K.
, et al.
"Antipurinergic therapy corrects the autism-like features in the poly (IC) mouse model.
" PloS one 8.
3 (2013): e57380.
[2]Naviaux, Jane C.
, et al.
"Antipurinergic therapy corrects the autism-like features in the Fragile X (Fmr1 knockout) mouse model.
" Molecular autism 6.
1 (2015): 1-20.
[3]Naviaux, Robert K.
, et al.
"Low ‐dose suramin in autism spectrum disorder: a small, phase I/II, randomized clinical trial.
" Annals of clinical and translational neurology 4.
7 (2017): 491-505.
[4]Zolkipli-Cunningham, Zarazuela, et al.
"Metabolic and behavioral features of acute hyperpurinergia and the maternal immune activation mouse model of autism spectrum disorder.
" PloS one 16.
3 (2021): e0248771
