Suramin

PaxMedica Provides Company Update and Continues to Advance PAX-101 Regulatory Strategy

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星期二, 五月 7, 2024
IBN, FDA, DSM-IV codes, Suramin, OTC, Spectrum, ASD, HAT, NDA, Medical device

The company is preparing to file a New Drug Application (NDA) with the FDA for the use of suramin in treating Human African Trypanosomiasis (HAT) as it has previously reported.

Key Points: 
  • The company is preparing to file a New Drug Application (NDA) with the FDA for the use of suramin in treating Human African Trypanosomiasis (HAT) as it has previously reported.
  • Suramin has been recognized for nearly a century as a standard treatment for HAT in East Africa.
  • In April 2024, PaxMedica responded to an urgent request from Malawi for an emergency release of suramin, underscoring the company’s commitment to addressing global health crises.
  • "We are on track to submit an NDA for PAX-101, and potentially secure an FDA Priority Review Voucher if approved."

PaxMedica Receives Emergency Request for IV Suramin from African Health Ministry for Use in Treating Fatal Sleeping Sickness

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星期二, 四月 16, 2024
FDA, Public, NDA, Food, Trial of the century, Neglected tropical diseases, MOH, IBN, Trypanosoma brucei, Patient, Incidence, Ministry, DSM-IV codes, Priority review, Infection, Standard of care, Real World, Ministry (collective executive), TBR, Suramin, Pharmaceutical industry

TARRYTOWN, New York, April 16, 2024 (GLOBE NEWSWIRE) -- via IBN -- PaxMedica , Inc. (NASDAQ: PXMD ), a biopharmaceutical company focused on advancing treatments for neurological disorders, today announced it has received an urgent request from the Ministry of Health (MOH) of Malawi, asking for emergency access to IV suramin to avert a potential humanitarian crisis brought on by dwindling supplies of drugs used routinely to save lives in that region of Africa.

Key Points: 
  • TARRYTOWN, New York, April 16, 2024 (GLOBE NEWSWIRE) -- via IBN -- PaxMedica , Inc. (NASDAQ: PXMD ), a biopharmaceutical company focused on advancing treatments for neurological disorders, today announced it has received an urgent request from the Ministry of Health (MOH) of Malawi, asking for emergency access to IV suramin to avert a potential humanitarian crisis brought on by dwindling supplies of drugs used routinely to save lives in that region of Africa.
  • PaxMedica, which just last week announced that it has completed execution of its three pivotal registration/validation batches of PAX-101 (an IV form of suramin), has brought this emergency request to the attention of the U.S. Food and Drug Administration (FDA) to determine potential impact, if any, on the ongoing development program and NDA submission plans for PAX-101.
  • PaxMedica has previously announced the completion of its recent Type B meeting with FDA in preparation for submitting an NDA for the use of PAX-101 in the treatment of the rare and fatal trypanosomal infection, Trypanosoma brucei rhodesiense, caused by the bite of a tsetse fly.
  • ( PaxMedica - A Promising Path in Autism ) “Having the highest incidence of TBr HAT in the world, the Malawi Ministry of Health enabled PaxMedica to conduct the first and only analysis of efficacy in the actual setting where historically the vast majority of these infections have been successfully treated”, said Weisman.

PaxMedica Achieves Key Milestone in the Development of PAX-101 And Provides Update on Potential NDA Submission

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星期四, 四月 11, 2024
FDA, Tropical disease, PRV, NDA, Food, CDC, HAT, Research, IBN, Trypanosoma brucei, DSM-IV codes, Suramin, Autism spectrum, Pharmaceutical industry

A successful review and approval of the NDA could further qualify the company for a Tropical Disease Priority Review Voucher (PRV).

Key Points: 
  • A successful review and approval of the NDA could further qualify the company for a Tropical Disease Priority Review Voucher (PRV).
  • PaxMedica plans to fund a sustainable global supply chain for PAX-101, and further advance research and clinical trials to address Autism Spectrum Disorder.
  • “This is a very significant milestone for PaxMedica as it endeavors to move PAX-101 towards an NDA submission,” said Howard Weisman, chairman and CEO of PaxMedica.
  • “The long-term vision for PaxMedica is to further clinical investigation of PAX-101 as a treatment for individuals who struggle with Autism Spectrum Disorder.

PaxMedica Inc. Featured in Syndicated Broadcast Highlighting FDA Type-B Meeting to Review PAX-101 Pivotal Trial Data

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星期五, 十一月 17, 2023
NDA, CMC, DSM-IV codes, News, Suramin, IBN, Trypanosoma brucei, FDA, Pharmaceutical industry

The audio news release covers PaxMedica’s recent announcement of the completion of a type-B meeting with the FDA.

Key Points: 
  • The audio news release covers PaxMedica’s recent announcement of the completion of a type-B meeting with the FDA.
  • To hear the audio production, visit: https://nnw.fm/SZ3e2
    To read the original press release, visit: https://nnw.fm/LNWCG
    "This marks a pivotal moment for PaxMedica, and we are encouraged by the constructive feedback from the FDA in our recent type-B meeting.
  • We are particularly focused on completing the production of commercial lots under CMC regulatory guidelines, anticipating substantial time and cost savings.
  • We are committed to advancing efficiently in the months ahead to bring PAX-101 closer to those in need."

PaxMedica Acquires Suramin Research Assets from Rediscovery Life Sciences to Accelerate NDA Submission for PAX-101

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星期二, 十月 31, 2023
FDA, IBN, African trypanosomiasis, CMC, Acquisition, Acute kidney injury, Research, Chronic kidney disease, Suramin, DSM-IV codes, NDA, RLS, Pharmaceutical industry

TARRYTOWN, New York, Oct. 31, 2023 (GLOBE NEWSWIRE) -- via IBN -- PaxMedica , Inc. (Nasdaq: PXMD ), a pioneering biopharmaceutical company specializing in cutting-edge treatments for neurological disorders, announced today the successful acquisition of certain suramin research assets from Rediscovery Life Sciences (RLS).

Key Points: 
  • TARRYTOWN, New York, Oct. 31, 2023 (GLOBE NEWSWIRE) -- via IBN -- PaxMedica , Inc. (Nasdaq: PXMD ), a pioneering biopharmaceutical company specializing in cutting-edge treatments for neurological disorders, announced today the successful acquisition of certain suramin research assets from Rediscovery Life Sciences (RLS).
  • These assets were previously dedicated to the study of suramin's potential efficacy in treating acute kidney injury resulting from chronic kidney disease.
  • The integration of the valuable data from Rediscovery Life Sciences will serve as a complementary component in the planned submission for the NDA, further solidifying the company's progression toward this critical milestone.
  • In a recent statement, Howard Weisman , Chairman and CEO of PaxMedica, emphasized the significance of this acquisition, stating, "Acquiring the research assets from Rediscovery Life Sciences marks a significant leap forward in our journey to expedite the NDA submission process for PAX-101.

PaxMedica's Research on Low Dose Suramin for Autism Spectrum Disorder Accepted for Publication

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星期四, 十月 26, 2023
Spectrum, IBN, Manuscript, Health, Autism spectrum, MD, Psychiatry, Research, Evidence-based medicine, Suramin, Annals, ASD, Constance, Pharmaceutical industry

TARRYTOWN, N.Y. , Oct. 26, 2023 (GLOBE NEWSWIRE) -- via IBN -- PaxMedica , Inc. (Nasdaq: PXMD ) a clinical-stage biopharmaceutical company, is excited to announce that the Annals of General Psychiatry, an internationally recognized scientific psychiatry publication, has accepted the manuscript titled "Randomized clinical trial of low dose suramin intravenous infusions for treatment of autism spectrum disorder" for publication.

Key Points: 
  • TARRYTOWN, N.Y. , Oct. 26, 2023 (GLOBE NEWSWIRE) -- via IBN -- PaxMedica , Inc. (Nasdaq: PXMD ) a clinical-stage biopharmaceutical company, is excited to announce that the Annals of General Psychiatry, an internationally recognized scientific psychiatry publication, has accepted the manuscript titled "Randomized clinical trial of low dose suramin intravenous infusions for treatment of autism spectrum disorder" for publication.
  • This groundbreaking research, authored by PaxMedica’s Chief Medical Officer, Dr. David Hough, MD, along with nine co-authors, highlights the potential of monthly suramin intravenous infusions as a safe and potentially efficacious treatment for the core symptoms of Autism Spectrum Disorder (ASD).
  • "The acceptance of this manuscript represents a significant milestone in PaxMedica's continued dedication to pioneering innovative treatments for Autism Spectrum Disorder.
  • As the manuscript progresses toward publication, PaxMedica extends its gratitude to the Annals of General Psychiatry for their support in sharing this essential research with the global scientific community.

PaxMedica, Inc. Announces Second Quarter 2023 Financial Results and Business Update

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星期三, 八月 9, 2023
Suramin, IV, Spectrum, African, NDA, Disorder, SAHPRA, US, Patient, ASD, South African Health Products Regulatory Authority, Emodin, Security (finance), TBR, Hand, US FDA, Common, Pharmaceutical industry

TARRYTOWN, NY, Aug. 09, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – PaxMedica, Inc. (Nasdaq: PXMD), a clinical stage biopharmaceutical company focusing on the development of novel anti-purinergic drug therapies (“APT”) for the treatment of disorders with intractable neurologic symptoms, today provided a business update and reported financial results for the second quarter 2023, ended June 30, 2023.

Key Points: 
  • TARRYTOWN, NY, Aug. 09, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – PaxMedica, Inc. (Nasdaq: PXMD), a clinical stage biopharmaceutical company focusing on the development of novel anti-purinergic drug therapies (“APT”) for the treatment of disorders with intractable neurologic symptoms, today provided a business update and reported financial results for the second quarter 2023, ended June 30, 2023.
  • Importantly, this positive topline data from our retrospective HAT-301 study, demonstrated both statistically significant and clinically meaningful results.
  • Subsequent to quarter end, the Company received proceeds of approximately $0.8 million from the issuance of approximately 1.0 million shares of the Company’s common stock.
  • For PaxMedica’s complete financial results for the three-month period ended June 30, 2023, see the Company’s Quarterly Form 10-Q that will be filed with the Securities and Exchange Commission on August 9, 2023.

PaxMedica Announces Positive Top Line Results from the PAX-101 (intravenous suramin) Phase 3 African Sleeping Sickness Study, PAX-HAT-301

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星期一, 七月 24, 2023
HAT, Male, Suramin, PRV, Natural history, HIV, Diarrhea, Hospital, Priority review, Autism spectrum, Survival, African, NDA, Weakness, Record, Hope, Chest pain, Federal Food, Drug, and Cosmetic Act, Cough, GAO, TBG, Key Stage 1, Patient, ASD, Northrop Grumman B-2 Spirit, Physician, Lymph, Arsenic, Diagnosis, APT, FDA, Headache, TBR, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Roger Hawkins (drummer), Death, Somnolence, FD, Food, Safety, Fatigue, Disease, Malaria, Pharmaceutical industry, Nursing

These records included data from a few weeks of hospitalization while they were being evaluated and the diagnosis of TBR HAT confirmed.

Key Points: 
  • These records included data from a few weeks of hospitalization while they were being evaluated and the diagnosis of TBR HAT confirmed.
  • As their conditions began to deteriorate, patients were often treated with arsenic or related compounds, sent to a Sleeping Sickness Hospital, or sent home to die with their families.
  • The natural history records do not include long term outcomes data for many of the patients.
  • One suramin-treated patient tested positive for HIV (only 23% tested) and 16/76 (21%) of patients tested were positive for malaria.

PaxMedica Submits Clinical Trial Request in Autism Spectrum Disorder

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星期三, 六月 14, 2023
Suramin, Autism spectrum, API, Clinical trial, SAHPRA, ASD, South African Health Products Regulatory Authority, APT, IND, Safety, Pharmaceutical industry

TARRYTOWN, NY, June 14, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – PaxMedica, Inc. (Nasdaq: PXMD), a clinical stage biopharmaceutical company focusing on the development of novel anti-purinergic drug therapies (APT) for the treatment of Autism Spectrum Disorder (ASD) and other serious conditions with intractable neurologic symptoms, today announced that it has submitted a request to the South African Health Products Regulatory Authority (SAHPRA), seeking approval to conduct a double-blind, placebo-controlled study, PAX-ASD-101.  This trial will seek to enroll a total of 30 subjects with confirmed ASD, ages 4 to 18, at multiple sites in South Africa.  This is the first new clinical trial on the safety, tolerability, and efficacy of suramin since the Company announced the results of its prior Phase II trial in 2021. Enrollment is expected to begin in Q4 2023, following SAHPRA’s potential approval later this summer.

Key Points: 
  • This trial will seek to enroll a total of 30 subjects with confirmed ASD, ages 4 to 18, at multiple sites in South Africa.
  • This is the first new clinical trial on the safety, tolerability, and efficacy of suramin since the Company announced the results of its prior Phase II trial in 2021.
  • PaxMedica is also preparing additional submissions for planned PAX-101 trials with other regulatory authorities outside of South Africa in 2023.
  • “In 2021, PaxMedica reported that it had completed a Phase II clinical trial on the use of suramin in boys with ASD.

PaxMedica Completes HAT-301 Registrational Trial for PAX-101

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星期四, 六月 1, 2023
Real, Suramin, PRV, Natural history, Priority review, Infection, African, NDA, Federal Food, Drug, and Cosmetic Act, GAO, Patient, Standard of care, ASD, APT, FDA, TBR, FD, Food, Pharmaceutical industry, Autism spectrum

TARRYTOWN, NY, June 01, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – PaxMedica, Inc. (Nasdaq: PXMD), a clinical stage biopharmaceutical company focusing on the development of novel anti-purinergic drug therapies (APT) for the treatment of Autism Spectrum Disorder (ASD), and other serious conditions with intractable neurologic symptoms, today announced that the eligibility review and final enrollment for the company’s Real World Evidence study (HAT-301) has been completed. Patient eligibility was assessed for inclusion by an Independent Study Adjudication Committee which included a total of three subject matter expert medical reviewers.

Key Points: 
  • Patient eligibility was assessed for inclusion by an Independent Study Adjudication Committee which included a total of three subject matter expert medical reviewers.
  • Howard Weisman, Chief Executive Officer of PaxMedica, commented, “Database lock for the HAT-301 study is a significant threshold event for PAX-101.
  • With this achievement, PaxMedica has completed a critical step in filing for potential U.S. market approval for this important, life-saving treatment.
  • This remains central to our strategy to build and support sustainable long term shareholder value.”