PaxMedica Reports First Patient Treated with PAX-101 for Fatal African Sleeping Sickness Infection
PaxMedica (OTC: PXMD) has announced a significant milestone in its global health efforts. The first patient with Human African Trypanosomiasis (HAT), or African Sleeping Sickness, has been treated with PAX-101, an intravenous form of Suramin, in Malawi. This comes after the Malawi Ministry of Health made an emergency request for PaxMedica to provide access to PAX-101 due to a critical global shortage of Suramin.
The company has also received feedback from the U.S. FDA on plans to establish a patient registry in Malawi to document treatment outcomes with PAX-101. This registry will support the upcoming New Drug Application (NDA) for PAX-101 in treating Stage 1 HAT. PaxMedica expects to submit the NDA in the near future, using data from the PAX-HAT-301 Real World Evidence Phase 3 study as a historical control.
PaxMedica (OTC: PXMD) ha annunciato un traguardo significativo nei suoi sforzi per la salute globale. Il primo paziente affetto da Tripanosomiasi Africana Umana (HAT), o Malattia del sonno africano, è stato trattato con PAX-101, una forma endovenosa di Suramina, in Malawi. Questo arriva dopo che il Ministero della Salute del Malawi ha fatto una richiesta d'emergenza a PaxMedica per fornire accesso a PAX-101 a causa di una grave carenza globale di Suramina.
La compagnia ha anche ricevuto riscontri dalla FDA degli Stati Uniti sui piani per stabilire un registro dei pazienti in Malawi per documentare gli esiti del trattamento con PAX-101. Questo registro supporterà la prossima Domanda di Nuovo Farmaco (NDA) per PAX-101 nel trattamento della HAT di Stadio 1. PaxMedica prevede di presentare la NDA nel prossimo futuro, utilizzando i dati dello studio PAX-HAT-301 Evidence del Mondo Reale di Fase 3 come controllo storico.
PaxMedica (OTC: PXMD) ha anunciado un hito significativo en sus esfuerzos de salud global. El primer paciente con Tripanosomiasis Africana Humana (HAT), o Enfermedad del Sueño Africana, ha sido tratado con PAX-101, una forma intravenosa de Suramina, en Malawi. Esto ocurre después de que el Ministerio de Salud de Malawi hiciera una solicitud de emergencia a PaxMedica para proporcionar acceso a PAX-101 debido a una grave escasez mundial de Suramina.
La compañía también ha recibido comentarios de la FDA de EE. UU. sobre los planes para establecer un registro de pacientes en Malawi para documentar los resultados del tratamiento con PAX-101. Este registro apoyará la próxima Solicitud de Nuevo Medicamento (NDA) para PAX-101 en el tratamiento de HAT de Etapa 1. PaxMedica espera presentar la NDA en un futuro cercano, utilizando datos del estudio PAX-HAT-301 de Evidencia del Mundo Real de Fase 3 como control histórico.
PaxMedica(OTC: PXMD)는 글로벌 건강 노력에서 중요한 이정표를 발표했습니다. 말라위에서 수연주사 형태의 수라민인 PAX-101으로 아프리카 수면병(HAT) 환자 첫 명이 치료되었습니다. 이는 말라위 보건부가 수라민의 심각한 글로벌 부족으로 인해 PaxMedica에 PAX-101 접근을 긴급 요청한 후에 이루어진 일입니다.
회사는 또한 PAX-101로 치료 결과를 문서화하기 위해 말라위에서 환자 등록부를 설립할 계획에 대해 미국 FDA로부터 피드백을 받았습니다. 이 등록부는 HAT 1단계 치료를 위한 PAX-101의 신약 신청(NDA)에 대한 지원을 할 것입니다. PaxMedica는 PAX-HAT-301 실제 증거 3상 연구의 데이터를 역사적 대조군으로 활용하여 가까운 미래에 NDA를 제출할 계획입니다.
PaxMedica (OTC: PXMD) a annoncé un jalon important dans ses efforts de santé mondiale. Le premier patient atteint de Trypanosomiasis humaine africaine (HAT), ou de la maladie du sommeil africaine, a été traité avec PAX-101, une forme intraveineuse de Suramine, au Malawi. Cela fait suite à la demande d'urgence du ministère de la Santé du Malawi pour que PaxMedica fournisse un accès à PAX-101 en raison d'une pénurie mondiale critique de Suramine.
L'entreprise a également reçu des retours de la FDA des États-Unis concernant ses projets d'établir un registre des patients au Malawi pour documenter les résultats des traitements avec PAX-101. Ce registre soutiendra la prochaine Demande de Nouveau Médicament (NDA) pour PAX-101 dans le traitement de la HAT au stade 1. PaxMedica prévoit de soumettre la NDA dans un avenir proche, en utilisant les données de l'étude PAX-HAT-301 Evidence Réelle de Phase 3 comme témoin historique.
PaxMedica (OTC: PXMD) hat einen bedeutenden Meilenstein in seinen globalen Gesundheitsanstrengungen bekannt gegeben. Der erste Patient mit der humanen afrikanischen Trypanosomiasis (HAT), auch bekannt als afrikanische Schlafkrankheit, wurde in Malawi mit PAX-101, einer intravenösen Form von Suramin, behandelt. Dies geschah, nachdem das Gesundheitsministerium von Malawi eine Notfallanfrage an PaxMedica gestellt hatte, um Zugang zu PAX-101 zu erhalten, aufgrund eines kritischen globalen Mangels an Suramin.
Das Unternehmen hat auch Feedback von der US-amerikanischen FDA zu den Plänen erhalten, ein Patientenregister in Malawi einzurichten, um die Behandlungsergebnisse mit PAX-101 zu dokumentieren. Dieses Register wird die bevorstehende Neurologische Arzneimittelanwendung (NDA) für PAX-101 zur Behandlung der Stage 1 HAT unterstützen. PaxMedica plant, die NDA in naher Zukunft einzureichen, wobei Daten aus der PAX-HAT-301-Studie als historische Kontrolle genutzt werden.
- First patient successfully treated with PAX-101 for African Sleeping Sickness in Malawi
- Positive response from Malawi's Ministry of Health regarding PAX-101's effectiveness
- Progress towards NDA submission for PAX-101 as a treatment for HAT
- Establishment of a patient registry in Malawi to support NDA application
- None.
Company provides update on regulatory progress towards US NDA submission
TARRYTOWN, NY / ACCESSWIRE / August 27, 2024 / PaxMedica, Inc. (OTC: PINKPXMD), a clinical-stage biopharmaceutical company dedicated to advancing treatments for neurological disorders, is pleased to announce a significant milestone in its global health efforts. The Malawi Ministry of Health has informed the company that a patient suffering from the potentially fatal parasitic infection known as Human Africa Trypanosomiasis Brucei Rhodesiense, (HAT), commonly referred to as African Sleeping Sickness, has recently received treatment with PAX-101, an intravenous form of Suramin, and is recovering at home. The Rhodesiense strain of Human African Trypanosomiasis is nearly
In April, the company announced that the Ministry of Health of Malawi made an emergency request for PaxMedica to provide immediate access to the recently completed validation and registration batches of PAX-101 (IV Suramin). This urgent request set in motion several important steps to rapidly respond to a critical global shortage of Suramin which is used routinely to combat HAT in Malawi. PaxMedica informed the U.S. FDA Office of Global Policy and Strategy that the company had provided a limited quantity of its formulation of IV Suramin, PAX-101, to Malawi's Ministry of Health, for immediate use.
Howard Weisman, CEO of PaxMedica, commented, "This first use of PAX-101 to treat a critically ill patient with Stage 1 HAT infection is an important milestone for the company following years of investment in the formulation and commercial scale-up of Suramin, the active pharmaceutical ingredient of PAX-101, with the company's supply chain partners. We were contacted by the government of Malawi after sustained shortages of IV Suramin in the region in the past year, and we could not ignore their pleas for help. Responding to this extraordinary request demonstrates our commitment to provide this essential medicine to some of the world's most vulnerable people."
Marshal Lemerani, Director of Neglected Tropical Diseases at the Ministry of Health in Malawi, expressed the nation's gratitude, stating, "We know that access to IV Suramin is necessary for us to save lives in our fight against HAT and, through the generosity of PaxMedica, we are now able to respond to the desperate need for this treatment. The results we've seen so far are very promising, and having a company committed to produce this vital drug offers renewed hope for our patients, and strengthens our ability to combat this devastating disease."
PaxMedica has also received feedback from U.S. Food and Drug Administration (FDA) on proposed plans to work with the Malawi Neglected Tropical Disease Program to establish a patient registry in Malawi for documenting treatment outcomes with PAX-101. This registry will be used to support the upcoming New Drug Application (NDA) for the use of PAX-101 in the treatment of Stage 1 HAT with data from the landmark PAX-HAT-301 Real World Evidence Phase 3 African Sleeping Sickness Study as previously reported by the company as a historical control. The company expects to submit an NDA for PAX-101 as a treatment for HAT in the near future.
About PaxMedica
PaxMedica, Inc. is a forward-looking clinical-stage biopharmaceutical firm specializing in cutting-edge anti-purinergic drug therapies (APT) aimed at addressing a range of challenging neurologic disorders. Our comprehensive portfolio encompasses a spectrum of conditions, including neurodevelopmental disorders such as Autism Spectrum Disorder (ASD), as well as other critical areas within the neurology field. Additionally, we intend to provide the rest of the world with an additional, reliable source of suramin, the accepted standard of care for Stage 1, Trypanosoma Brucei Rhodesiense.
We are dedicated to the continuous development and evaluation of our pioneering program, PAX-101, an intravenous suramin formulation that lies at the heart of our efforts, particularly focused on innovative ASD treatment solutions. Our ongoing research initiatives not only prioritize the needs of ASD patients, but also extend to exploring potential therapeutic applications for related conditions. To learn more about our transformative work, please visit www.paxmedica.com.
Interested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for Email Alerts at https://www.paxmedica.com/email-alerts and by following PaxMedica on Twitter and LinkedIn.
Forward-Looking Statements
This press release contains "forward-looking statements." Forward-looking statements reflect our current view about future events. Investors can identify these forward-looking statements by words or phrases such as "may," "will," "could," "expect," "anticipate," "aim," "estimate," "intend," "plan," "believe," "is/are likely to," "propose," "potential," "continue" or similar expressions. These forward-looking statements include our anticipated clinical program, the timing and success of our anticipated data announcements, pre-clinical and clinical trials and regulatory filings, and distribution and demand for our product candidates. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company's current expectations and projections about future events that the Company believes may affect its financial condition, results of operations, business strategy and financial needs. Such risks and uncertainties include, but are not limited to, risks associated with the Company's development work, including any delays or changes to the timing, cost and success of the Company's product development and clinical trials, risk of insufficient capital resources, cash funding and cash burn, regulatory approvals and risks associated with intellectual property and infringement claims. The Company undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results described in the Company's "Risk Factors" section and other sections in its most recent Annual Report on Form 10-K, and subsequent quarterly and other filings with the U.S. Securities and Exchange Commission.
Contacts
PaxMedica, Inc.
303 S Broadway,
Suite 125.
Tarrytown, NY 10591
www.paxmedica.com
Media Contact
media@paxmedica.com
Investor Contact
Scott McGowan
InvestorBrandNetwork (IBN)
Phone: 310.299.1717
ir@paxmedica.com
www.paxmedica.com/investors
SOURCE: PaxMedica, Inc.
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FAQ
What is the significance of PaxMedica's PAX-101 treatment for African Sleeping Sickness?
How is PaxMedica progressing with the FDA approval process for PAX-101?
What is the current status of Suramin availability for treating African Sleeping Sickness?
How will PaxMedica's patient registry in Malawi support their NDA for PAX-101?
