Suramin

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

Retrieved on: 
Friday, November 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

Retrieved on: 
Tuesday, October 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

Retrieved on: 
Thursday, October 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

Retrieved on: 
Wednesday, August 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

Retrieved on: 
Monday, July 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

Retrieved on: 
Wednesday, June 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

Retrieved on: 
Thursday, June 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.”

PaxMedica, Inc. Provides First Quarter 2023 Business Update; Phase 3 HAT-301 Top Line Results Expected in Second Half 2023

Retrieved on: 
Monday, May 15, 2023
HAT, Suramin, PRV, Priority review, Spectrum, Tropical disease, Clinical trial, NDA, Coronavirus Scientific Advisory Board, Disorder, Food and Drug Administration Amendments Act of 2007, ASD, Security (finance), FDA, IND, Food, Pharmaceutical industry, Cryptocurrency

Howard Weisman, Chief Executive Officer of PaxMedica, commented, “During the first quarter we’ve continued working hard to advance the ongoing retrospective Phase 3 HAT-301 trial and we continue to expect to announce top line results in the second half of 2023.

Key Points: 
  • Howard Weisman, Chief Executive Officer of PaxMedica, commented, “During the first quarter we’ve continued working hard to advance the ongoing retrospective Phase 3 HAT-301 trial and we continue to expect to announce top line results in the second half of 2023.
  • PaxMedica had 13,920,234 million common shares issued and outstanding at March 31, 2023.
  • Subsequent to quarter end, the Company received proceeds of approximately $1.1 million from the issuance of approximately 0.6 million shares of the Company’s common stock.
  • For PaxMedica’s complete financial results for the three-month period ended March 31, 2023, see the Company’s Quarterly Form 10-Q that will be filed with the Securities and Exchange Commission on May 15, 2023.

PaxMedica, Inc. Provides Business Update and Reports Fourth Quarter 2022 Financial Results

Retrieved on: 
Thursday, March 30, 2023
HAT, Suramin, Clinical trial, NDA, Disorder, ASD, Security (finance), FDA, TBR, IND, Pharmaceutical industry

TARRYTOWN, NY, March 29, 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 fourth quarter and year ended December 31, 2022.

Key Points: 
  • Howard Weisman, Chief Executive Officer of PaxMedica, commented, “The fourth quarter capped a strong year for PaxMedica.
  • The final results are expected to be announced in the second half of 2023.
  • During the year ahead we also expect to complete any remaining necessary pre-clinical, non-clinical and clinical studies to support our NDA submission for the HAT indication.
  • For PaxMedica’s complete financial results for the twelve-month period ended December 31, 2022, see the Company’s Annual Form 10-K filed with the Securities and Exchange Commission on March 29, 2023.

PaxMedica Holds Meeting of Scientific Advisory Board

Retrieved on: 
Monday, March 20, 2023
University of California, San Diego Performance-Based Skills Assessment, Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, Suramin, University, Pediatrics, State University of New York Upstate Medical University, Autism spectrum, Spectrum, Baylor University, Coronavirus Scientific Advisory Board, Doctor of Philosophy, Disorder, MD, Pathology, ASD, Behavioural sciences, Baylor College of Medicine, VCU School of Medicine, Pharmaceutical industry, Psychiatry, Medicine

TARRYTOWN, NY, March 20, 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 announced that it held a Scientific Advisory Board meeting on March 10-12, 2023.  A number of new members have been added to the board, which consists of many key opinion leaders in autism spectrum disorder (ASD) in the United States including:

Key Points: 
  • Board Includes Several Key Opinion Leaders on Autism Spectrum Disorder in U.S.
    TARRYTOWN, NY, March 20, 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 announced that it held a Scientific Advisory Board meeting on March 10-12, 2023.
  • We continue to be very excited about studying a product for the potential treatment of the core symptoms of autism spectrum disorder.”
    Dr. Robert Naviaux added, “At the scientific advisory board meeting this weekend, experts from many different areas of medicine came together to share their thoughts on how suramin may work in ASD and how it might work in several other complex disorders.
  • What emerged was a clear vision for the next steps needed to test suramin in autism.
  • This is expected to be done in a series of international, multicenter, clinical trials that are projected to begin in 2024.”