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Tharimmune's Promising FDA Feedback for TH104 Program

Tharimmune, Inc., a company publicly traded on NASDAQ under the ticker THAR, has recently made headlines with positive developments regarding its lead clinical asset, TH104. This medication aims to protect against respiratory depression linked to fentanyl and other potent opioids, a growing concern in today's opioid crisis. The company has provided an update following its engagement with the U.S. Food and Drug Administration (FDA), which has yielded favorable feedback on their proposed simulation modeling plan for this important therapeutic.

In a formal Type D meeting with the FDA, Tharimmune presented the initial results of its pharmacokinetic (PK) simulations along with plans for further detailed modeling. The FDA's approval of these plans represents a crucial milestone in advancing TH104, a buccal film designed for non-injective use and self-administration. This approval is especially significant for first responders who may need to act quickly in high-risk environments.

In conjunction with moving forward on regulatory fronts, the company is also set to initiate a comprehensive Chemistry, Manufacturing, and Controls (CMC) strategy. This CMC plan will play an essential role in ensuring that TH104 is manufactured at the highest quality and consistency necessary for clinical development and eventual commercial launch.

Key Findings from the Simulation Analysis

The simulation analysis conducted on TH104 has revealed some impressive findings:

1. Rapid Onset: The simulations suggest that a conservative concentration of nalmefene, the active ingredient in TH104, could reach levels that provide protection against respiratory depression in as little as 30 minutes post-administration.

2. Sustained Protection: The protective concentration level derived from the model indicates that it could be maintained for approximately 24 hours, significantly longer than alternatives like naloxone injections, which typically offer protection for only 30 to 90 minutes.

3. Potential Superiority: This prolonged prophylactic window positions TH104 as a potentially superior option for use in scenarios where immediate medical assistance is not readily available, such as military or emergency response situations involving high-potency opioid exposure.

The effective buccal film delivery system also enhances its usability. It allows rapid absorption and can easily be self-administered, making it a practical choice for first responders, particularly those equipped with full protective gear.

Earlier this year, Tharimmune also received confirmation from the FDA stating that no additional clinical trials are necessary prior to submitting for a 505(b)(2) New Drug Application (NDA). This not only paves the way for expedited development but also highlights the potential role TH104 could play in addressing national health security challenges. As the prevalence of opioid overdoses continues to escalate, the urgency for effective countermeasures has never been more pressing.

With the backing from the FDA and the promising findings from their product modeling plans, Tharimmune is firmly dedicated to progressing TH104. By focusing on high-quality production and addressing critical gaps in opioid overdose management, Tharimmune aims to offer an effective and patient-friendly treatment option that can significantly impact public health safety.

About Tharimmune, Inc.

Tharimmune is at the forefront of the biopharmaceutical industry, pioneering both clinical-stage biotechnology initiatives and blockchain solutions through its support for the Canton Network. As the first publicly traded entity leveraging Canton Coin, the company is dedicated to transforming financial markets along with advancing healthcare solutions. For up-to-date information on TH104 and other initiatives, please visit www.tharimmune.com.

This important development not only marks a significant achievement for Tharimmune but also offers hope for safer responses to the opioid crisis. As the company moves toward its NDA submission, the healthcare community and potential users of TH104 eagerly await what could become a groundbreaking solution to a persistent public health emergency.