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Thursday, June 1, 2023

PaxMedica Inc (NASDAQ: PXMD) in Focus as Company Advances PAX-101 (Suramin) Through Phase 3 HAT-301 Trials

PaxMedica Inc (NASDAQ: PXMD) is a biotech Company trading just below the $2 mark that continues to be brought up on the subreddit short squeeze. The stock hit $10.48 after its IPO in October of last year but has traded as low as $1.30 since then.  

PXMD initiated a pivotal Phase 3 HAT-301 trial in November that is a retrospective, controlled analysis of suramin for the treatment of the rare and fatal tropical disease, Stage 1 Trypanosoma Brucei Rhodesiense Human African Trypanosomiasis (Stage 1 TBR HAT) with results expected in 2nd half of 2023. We will be updating on PXMD when more details emerge so make sure you are subscribed to newsytrends.com by entering your email below.

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PaxMedica Inc (NASDAQ: PXMD) is a clinical stage biopharmaceutical company focusing on the development of anti-purinergic drug therapies for the treatment of disorders with intractable neurologic symptoms, ranging from neurodevelopmental disorders, including Autism Spectrum Disorder (“ASD”), to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (“ME/CFS”), a debilitating physical and cognitive disorder believed to be viral in origin and now with rising incidence globally due to the long term effects of SARS-CoV-2 (“COVID-19”). 

PaxMedica lead programs PAX-101 and PAX-102 utilize its proprietary source of suramin sodium, a broadly acting APT that has been around for over 100 years. Given suramin’s historical use as a treatment for Human African Trypanosomiasis (HAT), or African Sleeping Sickness, PaxMedica is also developing PAX-101 as a treatment for HAT. The Company expects that FDA approval in HAT could confer, upon PaxMedica, a potential Priority Review Voucher (PRV). 

PAX-101 (IV Suramin) for ASD completed a Phase 2B study for ASD in 2021. Suramin is a broadly acting anti-purinergic therapy and has reported positive results from a dose range study. The results of our Phase 2B study, which targeted 52 subjects across six sites in South Africa, were presented to AACAP in October 2021. 

PAX-101 (IV Suramin) for FXTAS has been evaluated in several preclinical studies of Fragile X related animal models. PaxMedica intends to submit an Investigational New Drug (IND) application and start a Phase 2 study in 2021. PAX-101 for FXTAS is expected to qualify for Orphan Drug exclusivity. 

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PAX-102 (Intranasal Suramin) PaxMedica has developed a proprietary intranasal formulation of suramin that is currently being evaluated in ASD and other neurodevelopmental conditions. The Company has also conducted several preclinical studies to evaluate other anti-purinergic therapies (APTs) that are more selective to specific purinergic receptors and may offer additional benefits over suramin. 

PAX-101 (IV Suramin) for HAT PaxMedica’s most advanced program is the pursuit of PAX-101 for early-stage East African HAT. Suramin has been in continuous use as the standard of care for the treatment of early-stage East African sleeping sickness for more than 100 years. The Company seeks to leverage this history of use, as well as patient data that we have exclusively licensed, in order to obtain an FDA approval for PAX-101. We believe that an approval of PAX-101 in HAT would qualify for New Chemical Entity exclusivity, Orphan Drug exclusivity, and could confer upon us the receipt of a Priority Review Voucher (PRV) by the FDA. 

PXMD is pursuing an FDA program that provides valuable incentives for achieving an initial NDA approval as an orphan designated drug. One of the most critical steps in this process is a Phase 3 trial for HAT-301, that PaxMedica initiated in November. This trial, which uses existing retrospective data that PaxMedica has exclusively licensed from key hospitals in Malawi and Uganda, is expected to advance PAX-101 towards FDA submission for the treatment of Stage 1 Trypanosoma Brucei Rhodesiense Human African Trypanosomiasis, (sometimes referred to as HATr, Human African Trypanosomiasis rhodesiense). This rare and fatal form of sleeping sickness has been the clinical target indication for suramin since it was first discovered in the early 1900s. PaxMedica expects final results for the HAT-301 study in the second half of 2023. 

This is important because, if this trial is successful, PaxMedica expects to seek accelerated approval for an NDA for PAX-101 as the first treatment for HATr approved under the U.S. Rare Tropical Disease Priority Review Voucher program. The Company expects to monetize a Priority Review Voucher, if received. PaxMedica believes that this has the potential to be the fastest route to generate funding to complete a comprehensive clinical program for the use of PAX-101 for core symptoms of autism spectrum disorder and other neurodevelopmental conditions. 

In a recent update PXMD CEO Howard Weisman stated: “The fourth quarter capped a strong year for PaxMedica. Most importantly, we initiated a pivotal Phase 3 HAT-301 trial in November that is a retrospective, controlled analysis of suramin for the treatment of the rare and fatal tropical disease, Stage 1 Trypanosoma Brucei Rhodesiense Human African Trypanosomiasis (Stage 1 TBR HAT). The final results are expected to be announced in the second half of 2023. To support our work, we signed a committed equity investment agreement for up to $20 million, also in November, and in February 2023, raised an additional $2.5 million in growth capital. 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. All of this work is to advance us toward the achievement of our most important objective – the submission of an IND to the FDA for a PAX-101 (suramin) clinical trial for the treatment of ASD in the U.S. which we intend to submit in 2024.”

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Currently trading at a $22 million market valuation PXMD os is 11,779,475 shares. PXMD is a biotech Company trading just below the $2 mark that continues to be brought up on the subreddit short squeeze as a potential squeeze. The stock hit $10.48 after its IPO in October of last year but has traded as low as $1.30 since then. PXMD initiated a pivotal Phase 3 HAT-301 trial in November that is a retrospective, controlled analysis of suramin for the treatment of the rare and fatal tropical disease, Stage 1 Trypanosoma Brucei Rhodesiense Human African Trypanosomiasis (Stage 1 TBR HAT) with results expected in 2nd half of 2023.  We will be updating on PXMD when more details emerge so make sure you are subscribed to newsytrends.com by entering your email below.

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Disclosure: we hold no position in PXMD either long or short and we have not been compensated for this article.

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