Kalyra Pharmaceuticals, Inc. — Department of Health and Human Services SBIR Phase II: NIDA

Description

DESCRIPTION provided by applicant Acute and chronic pain imposes a tremendous burden on society not only because of the associated human suffering but also the cost of medical treatment loss of productivity and disability payments which has been estimated to be up to $ billion per year in the USA alone Current treatments for pain are hampered by limited efficacy and acute or long term side effects Acetaminophen is an important drug in the management of pain however overdose which is quite common can lead to liver damage subsequent liver failure and even death A safe non liver toxic drug with equal or improved efficacy compared to acetaminophen would be a ground breaking new product for the treatment of pain Kalyra Pharmaceuticals has synthesized a number of structurally related acetaminophen analogs utilizing our toolbox of proprietary bioisosteres and discovered new highly potent analgesic compounds that do not form a toxic metabolite With proof of concept in hand further development of these analogues is the subject of this direct to Phase II proposal via the Specific Aims outlined below Phase II Non Clinical Development of a New Treatment for Pain Aim Further Characterization of Efficacy and In Vivo Pharmacology Aim ADMET Additional Pharmacology and Preliminary Toxicology Aim Pharmacokinetic Studies to Confirm Second Species Selection for Safety Aim Non Clinical Toxicology Studies in Support of Filing of an IND After completion of the IND enabling studies outlined in this proposal we anticipate the filing of an IND with the FDA to begin human clinical trials for the development of a novel safe effective and non addictive new treatment for the management of pain PUBLIC HEALTH RELEVANCE Pain imposes a tremendous burden on society Acetaminophen is an important drug in the management of pain however overdose can lead to liver damage subsequent liver failure and even death Kalyra has developed acetaminophen analogues that are more efficacious than acetaminophen without the risk of toxic metabolite formation With proof of concept in hand this proposal aims to conduct the additional non clinical studies required to select a development candidate and support the submission of an IND With preliminary proof of concept and efficacy data in hand we propose to develop a novel safe and non addictive therapy for the management of mild to moderate pain