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We are developing our lead drug candidate (acALY-18) as a wholly new class of anti-infective agents that are 'pathogen-agnostic'. Formulated as an injectable, acALY-18 will significantly reduce the risk of patients acquiring serious infections while hospitalized or undergoing out-patient surgical procedures.
Other products currently under development include
- An antagonist of inflammasome activation for the treatment of Scleroderma,
- A formulation of acALY-18 for the treatment of chronic Hepatitis B infection, and
- A formulation of acALY-18 for the treatment of late-onset Alzheimer's Disease.
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| Drug Development Pipeline |
The Company's lead drug candidate is in the pre-clinical stage of development. We anticipate filing an IND with the U.S. FDA within the next two years to commence clinical trial studies.
Our other drug candidates are in the development stage to optimize the drug substances and their formulation for non-parental routes of administration.
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TherimuneX retains the services of one of the leading FDA regulatory consulting firms - Biologics Consulting Group, LLC (Alexandria, VA). Resumes of the key personnel from BCG that are assigned to TherimuneX are provided.
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Melanie T. Hartsough, PhD
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David T. Lin, PhD
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Reginald D. Neal
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Nadine M. Ritter, PhD
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TherimuneX intends to retain a seasoned team of product development and commercial biopharmaceutical experts to advise and guide Management through the product development and commercialization pathway. Currently, we are discussing this role with the team from Altheln, Inc. (San Diego, CA), a multi-disciplinary life science consulting firm. Atheln provides integrated, cross-functional strategic and operational capabilities necessary during the early stage product development and commercialization phases. Atheln background information in the attached PDF.
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