PaxMedica, Inc. today announced that it has received approval from the South African Health Products Regulatory Agency (SAHPRA) for its clinical trial application to study the effects of PAX-101.
- Study has been approved by the South African Health Authority for individuals with documented COVID-19 infections who develop debilitating physical and neuropsychiatric symptoms that persist for more than 12 weeks after the viral infection has passed
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| [07-January-2022] |
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TARRYTOWN, N.Y., Jan. 7, 2022 /PRNewswire/ -- PaxMedica, Inc. ("PaxMedica" or the "Company"), a biopharmaceutical company focused on developing medicines that help overcome the challenges of living with complex neurological conditions, today announced that it has received approval from the South African Health Products Regulatory Agency (SAHPRA) for its clinical trial application to study the effects of PAX-101 (suramin intravenous (IV) infusions) in patients with Long COVID-19 Syndrome (LCS), also known as post-acute sequelae of SARS-CoV-2 infection. The study, PAX-LCS-101, will be a Phase 1B, prospective, randomized, placebo-controlled, double-blind, multiple-dose study. The study is expected to start enrolling patients in the first quarter of this year after obtaining South African National Ethics Committee approval. LCS is a serious, multi-system illness that results in significant impairment of functioning in many individuals after acute infection with COVID-19. The diagnosis of LCS is challenging as there are no specific tests to establish the diagnosis. Although there are many definitions proposed in the medical literature, most researchers define LCS as a syndrome that includes a protracted course of various physical and neuropsychiatric symptoms that persist for 12 weeks or more without an alternative explanation. The study is expected to enroll patients with persistent signs and symptoms of LCS, after a previously documented infection with the COVID-19 virus. The symptoms of LCS in each patient can vary but often include fatigue, "brain fog", pain, headaches, shortness of breath, difficulty with concentration and attention, sleep disturbance, orthostasis and dizziness, and decreased functioning as well as many associated symptoms such as joint and muscle pain, depression and anxiety. LCS has been observed to closely resemble another post-acute infection disorder known as myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS). In both disorders, fatigue is a prominent symptom and many of the other observed symptoms overlap. Both conditions may result in an inability to work or perform normal activities and in extreme cases of ME/CFS, have been documented to last for years, resulting in those affected becoming home-, if not bed-bound. PaxMedica plans to study PAX-101 as a treatment for both LCS and ME/CFS. "People who suffer from Long COVID Syndrome and ME/CFS have nearly identical physical symptoms and there may be a similarity in the underlying pathophysiology related to mitochondria and purinergic signaling. Using a purinergic antagonist, like suramin, may play an important role in addressing both of these syndromes," commented Robert Naviaux, MD, PhD and co-Director of the Mitochondrial and Metabolic Disease Center at the UCSD School of Medicine. This clinical trial is planned to study the safety and tolerability, efficacy, and PK of two doses of suramin (5 mg/kg and 10 mg/kg) in adults, 18 years and older, with LCS. Despite the significant unmet medical need for treatments of LCS, there are no currently approved medications for this disorder. There is growing consensus in the scientific and medical communities of the need for more research into the causes of LCS, and the potentially related disorder ME/CFS PAX-101 is also currently in Phase 2 for Autism Spectrum Disorder ("ASD"). The Company is also developing PAX-102, a proprietary intranasal formulation of suramin, for ASD and other neurologic disorders. About PaxMedica, Inc. Forward-Looking Statements These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential, "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. For more information, contact: Media Relations:
SOURCE PaxMedica |
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