CMTX BIOTECH, INC.

2024-07-09

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Department of Health and Human Services

A NOVEL, HOST-DIRECTED THERAPEUTIC FOR THE TREATMENT OF SULFUR MUSTARD INDUCED LUNG INJURY - PROJECT SUMMARY/ABSTRACT CMTX BIOTECH IS A DRUG DEVELOPMENT COMPANY WORKING TO COMMERCIALIZE A PIPELINE OF PROPRIETARY, NON- ANTIBIOTIC, CHEMICALLY-MODIFIED TETRACYCLINE (CMT) COMPOSITIONS AND FORMULATIONS FOR THE HOST-MODULATORY TREATMENT OF DISEASES WITH HIGH UNMET NEEDS, INCLUDING A PROPRIETARY, CLINICAL-STAGE, ORALLY-ADMINISTERED SMALL- MOLECULE DRUG CANDIDATE, INCYCLINIDE (CMT-3 / COL-3), AS A MEDICAL COUNTERMEASURE FOR THE TREATMENT OF EXPOSURE TO VESICANTS (BLISTER AGENTS) THAT MAY OCCUR IN CHEMICAL WARFARE, TERRORISM OR INDUSTRIAL ACCIDENTS. VESICATING AGENTS, INCLUDING DISTILLED MUSTARD (HD), MUSTARD GAS (H), MUSTARD/LEWISITE, MUSTARD/T, NITROGEN MUSTARD, SESQUI MUSTARD, AND SULFUR MUSTARD, CAN CAUSE MODERATE TO DEBILITATING INJURIES AND PAIN TO THE EYE, SKIN, AND MUCOUS MEMBRANES. THE PRIMARY MODES OF EXPOSURE ARE THROUGH CONTACT, INHALATION AND INGESTION. DEPENDING ON THE DOSE, ROUTE, AND DURATION OF EXPOSURE, TOXIC SYMPTOMS CAN RANGE IN VARYING DEGREES OF OCULAR AND DERMAL BURNS, BLISTER FORMATION, BRONCHOSPASM, DYSPNEA, PULMONARY EDEMA, BRONCHITIS, AND IMMUNE- AND BONE MARROW SUPPRESSION. SULFUR MUSTARD IS A HUMAN-MADE CHEMICAL WARFARE AGENT THAT CAUSES BLISTERING OF THE SKIN AND MUCOUS MEMBRANES ON CONTACT. VESICATING CHEMICALS HAVE BEEN IDENTIFIED BY THE U.S. DEPARTMENT OF HOMELAND SECURITY (DHS) AND THE DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) AS HIGHLY TOXIC CHEMICALS OF CONCERN TO PUBLIC HEALTH SECURITY DUE TO THE DEVASTATING HEALTH EFFECTS OF EXPOSURE. UNFORTUNATELY, NO KNOWN ANTIDOTE EXISTS FOR SULFUR MUSTARD EXPOSURE. TREATMENT CONSISTS OF REMOVING SULFUR MUSTARD FROM THE BODY AS SOON AS POSSIBLE AND PROVIDING SUPPORTIVE MEDICAL CARE IN A HOSPITAL SETTING OR BY TRAINED EMERGENCY PERSONNEL. THERE REMAINS A CRITICAL NEED FOR SAFE AND EFFECTIVE MEDICAL COUNTERMEASURES FOR THE TREATMENT OF ACUTE AND CHRONIC LUNG INJURIES CAUSED BY THE INHALATION OF SM. THE MARKET FOR TREATMENTS SPECIFICALLY TARGETING SULFUR MUSTARD EXPOSURE IS RELATIVELY LIMITED TO PURCHASES BY THE U.S. STRATEGIC NATIONAL STOCKPILE AND INTERNATIONAL EQUIVALENTS. HOWEVER, COMPANIES THAT SECURE FDA APPROVAL FOR A MEDICAL COUNTERMEASURE (MCM) AGAINST CERTAIN CHEMICAL, BIOLOGICAL, RADIOLOGICAL OR NUCLEAR (CBRN) THREATS ARE ELIGIBLE TO RECEIVE A PRIORITY REVIEW VOUCHER (PRV), WHICH ALLOWS THE RECIPIENT TO EXPEDITE THE REVIEW OF A FUTURE NEW DRUG APPLICATION (NDA) OR BIOLOGICS LICENSE APPLICATION (BLA) FOR A DIFFERENT PRODUCT OF THEIR CHOICE. PRVS CAN BE SOLD OR TRANSFERRED TO OTHER COMPANIES, WITH AN AVERAGE VALUE OF APPROXIMATELY $100M. OUR LEAD DRUG CANDIDATE IS A PLEIOTROPIC MATRIX METALLOPROTEINASE (MMP) MODULATOR WHICH INHIBITS PATHOLOGICALLY-EXCESSIVE COLLAGENOLYSIS AND RESOLVES SYSTEMIC INFLAMMATION. SAFETY OF THE COMPOUND HAS ALREADY BEEN DEMONSTRATED IN INVESTIGATIONAL NEW DRUG (IND)-ENABLING STUDIES. THE DRUG HAS BEEN EVALUATED IN SEVERAL CLINICAL TRIALS FOR THE TREATMENT OF DISEASES AS DISPARATE AS AIDS-RELATED KAPOSI’S SARCOMA, RECURRENT HIGH-GRADE GLIOMAS, REFRACTORY METASTATIC CANCER, ACNE, ROSACEA AND PERIODONTITIS. THE SPECIFIC AIMS OF THIS STTR ARE (A) TO DEMONSTRATE A DOSE-DEPENDENT SURVIVAL BENEFIT OF INCYCLINIDE (25MG/KG, 50MG/KG, OR 100MG/KG BY ORAL GAVAGE) IN AN ESTABLISHED RAT MODEL OF SULFUR MUSTARD (SM) INHALATION WITH DAILY TREATMENT INITIATED 24-HOURS POST-SM EXPOSURE AND CONTINUED FOR 28 DAYS, AND (B) TO EVALUATE THE EFFECT OF ORALLY-ADMINISTERED INCYCLINIDE ON THE PATHOGENESIS OF SM-INDUCED LUNG INJURY, PULMONARY FIBROSIS AND INFLAMMATORY BIOMARKERS. OUR LONG-TERM GOAL IS TO SECURE FDA APPROVAL FOR INCYCLINIDE AS A SAFE AND EFFECTIVE MEDICAL COUNTERMEASURE FOR SM-INDUCED LUNG INJURY. WE ANTICIPATE THAT OUR DRUG CANDIDATE WILL IMPROVE SURVIVAL AND MITIGATE SM-INDUCED LUNG INJURY IN EXPOSED RATS, REDUCE SM-INDUCED INJURY PARAMETERS AS ASSESSED THROUGH HISTOPATHOLOGY, AS WELL AS LUNG FIBROSIS AND KEY INFLAMMATORY BIOMARKERS. SUCCESSFUL COMPLETION OF THESE STUDIES WILL ALLOW CMTX BIOTECH TO (A) EVALUATE OUR DRUG CANDIDATE IN NON-RODENT ANIMAL MODEL OF SM-INDUCED LUNG INJURY, (B) PREPARE AND SUBMIT A PRE-IND MEETING REQUEST AND BRIEFING DOCUMENT, AND (C) SCALE-UP PRODUCTION OF THE DRUG SUBSTANCE AND DRUG PRODUCT UNDER CURRENT GOOD MANUFACTURING PRACTICES (CGMP).

299993.00

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2023-05-03

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Department of Health and Human Services

NOVEL SMALL MOLECULE DRUG CANDIDATE FOR THE PREVENTION OF BRONCHOPULMONARY DYSPLASIA - PROJECT SUMMARY/ABSTRACT CMTX BIOTECH IS A DRUG DEVELOPMENT COMPANY WORKING TO COMMERCIALIZE A PROPRIETARY, CLINICAL-STAGE, SMALL- MOLECULE DRUG CANDIDATE FOR THE PREVENTION OF RESPIRATORY DISTRESS SYNDROME (RDS) AND ITS LONG-TERM SEQUELAE, BRONCHOPULMONARY DYSPLASIA (BPD), IN PRETERM INFANTS. BPD IS A CHRONIC RESPIRATORY DISEASE THAT OCCURS IN PRETERM INFANTS WHO DEVELOP RDS FROM A COMBINATION OF LUNG IMMATURITY, INFLAMMATION, AND MECHANICAL INJURY FROM VENTILATION. BPD IS THE MOST COMMON ADVERSE OUTCOME OF PRETERM DELIVERY, AFFECTING UP TO 75% OF INFANTS BORN BEFORE 28 WEEKS OF GESTATION WORLDWIDE. EVERY YEAR IN THE U.S., APPROXIMATELY 380,000 OF THESE INFANTS ARE BORN, OF WHICH 50,000 ARE EXTREMELY LOW GESTATIONAL AGE NEWBORNS (ELGANS), 35% (18,000) OF WHICH DEVELOP BPD. THE MEDIAN COST OF HOSPITALIZATION ASSOCIATED WITH BPD DURING THE FIRST YEAR IN VERY LOW BIRTH WEIGHT INFANTS IS $377,871 PER INFANT, COMPARED TO $175,836 PER INFANT WITHOUT BPD. THERE ARE CURRENTLY NO FDA-APPROVED DRUGS SPECIFICALLY FOR THE PREVENTION AND TREATMENT OF BPD. THE CURRENT STANDARD OF CARE IS FOCUSED ON MINIMIZING LUNG DAMAGE AND PROVIDING RESPIRATORY SUPPORT WITH THE USE OF BRONCHODILATORS, DIURETICS, ANTIBIOTICS, SURFACTANT, AND STEROIDS, INCLUDING ANTENATAL STEROID TREATMENT OF THE MOTHER BEFORE PRETERM BIRTH. MOST AGENTS THAT ARE PRESCRIBED TO PREVENT BPD ARE ALSO USED FOR THE MANAGEMENT OF ESTABLISHED BPD, AND THESE THERAPIES LACK SOLID EVIDENCE OF EFFICACY. A RECENT CLINICAL STUDY CONCLUDED THAT HYDROCORTISONE IS NOT EFFECTIVE AT PREVENTING BPD IN PREMATURE INFANTS OR IMPROVING THEIR SURVIVAL. THERE REMAINS A CRITICAL UNMET NEED FOR SAFE AND EFFECTIVE THERAPEUTICS FOR THE PREVENTION OF BPD. OUR LEAD DRUG CANDIDATE IS A PLEIOTROPIC MATRIX METALLOPROTEINASE (MMP) MODULATOR WHICH INHIBITS PATHOLOGICALLY- EXCESSIVE COLLAGENOLYSIS AND RESOLVES SYSTEMIC INFLAMMATION. SAFETY OF THE COMPOUND HAS ALREADY BEEN DEMONSTRATED IN INVESTIGATIONAL NEW DRUG (IND)-ENABLING STUDIES. THE DRUG HAS BEEN EVALUATED IN A NUMBER OF CLINICAL TRIALS FOR THE TREATMENT OF DISEASES AS DISPARATE AS AIDS-RELATED KAPOSI’S SARCOMA, RECURRENT HIGH- GRADE GLIOMAS, REFRACTORY METASTATIC CANCER, ACNE, ROSACEA AND PERIODONTITIS. THE SPECIFIC AIMS OF THIS STTR ARE TO DETERMINE THE ABILITY OF OUR LEAD DRUG CANDIDATE TO PREVENT THE ONSET OF BPD IN A PRETERM PIGLET MODEL, AND TO EVALUATE ITS EFFECT ON THE PATHOGENESIS OF BPD AND INFLAMMATORY PATHWAYS. OUR LONG-TERM GOAL IS TO OBTAIN APPROVAL FROM THE FDA AND COMPARABLE INTERNATIONAL REGULATORY AUTHORITIES TO MARKET OUR DRUG CANDIDATE AS A SAFE AND EFFECTIVE INTERVENTION. WE ANTICIPATE THAT OUR DRUG CANDIDATE WILL INHIBIT BPD PROGRESSION, MITIGATE ACUTE LUNG INJURY AND RESPIRATORY DISTRESS, REDUCE THE NEED FOR INTENSIVE CARE AND INTUBATION, AND IMPROVE CLINICAL OUTCOMES FOR PRE-TERM INFANTS, INCLUDING OVERALL SURVIVAL. SUCCESSFUL COMPLETION OF THESE STUDIES WILL ALLOW CMTX BIOTECH TO ADVANCE OUR LEAD DRUG CANDIDATE TOWARDS CLINICAL TRIALS FOR THE PREVENTION OF BPD.

376752.00

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2023-06-21

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Department of Health and Human Services

AEROSOLIZED CHEMICALLY MODIFIED TETRACYCLINE NANOFORMULATION FOR THE TREATMENT OF ACUTE RESPIRATORY DISTRESS SYNDROME - PROJECT SUMMARY/ABSTRACT CMTX BIOTECH IS A DRUG DEVELOPMENT COMPANY WORKING TO RESCUE, DEVELOP AND COMMERCIALIZE A PROPRIETARY CLINICAL-STAGE DRUG CANDIDATE, INCYCLINIDE (CMT-3 / COL-3), FOR THE TREATMENT OF SEPSIS PATIENTS AT RISK OF ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS). ACCORDING TO THE U.S. CENTERS FOR DISEASE CONTROL (CDC), AT LEAST 1.7 MILLION AMERICAN ADULTS DEVELOP SEPSIS ANNUALLY, RESULTING IN NEARLY 270,000 DEATHS. SEPSIS ACCOUNTS FOR MORE THAN 50% OF HOSPITAL DEATHS, AND MORTALITY INCREASES DRAMATICALLY WITH GREATER DISEASE SEVERITY: 10–20% FOR SEPSIS, 20–40% FOR SEVERE SEPSIS, AND 40–80% FOR SEPTIC SHOCK. SEPSIS IS A MEDICAL EMERGENCY CHARACTERIZED BY SEVERE IMMUNE DYSREGULATION WITH A VERY COMPLEX IMMUNOPATHOGENESIS. ARDS IS A DEVASTATING COMPLICATION OF SEVERE SEPSIS, BOTH WITH SIMILAR UNDERLYING MECHANISMS CHARACTERIZED BY INFLAMMATION AND ENDOTHELIAL DYSFUNCTION. SEPSIS IS THE LEADING CAUSE OF ARDS AND ACCOUNTS FOR 32% OF THE ETIOLOGY OF THE CONDITION. APPROXIMATELY 6-7% OF SEPSIS PATIENTS RAPIDLY PROGRESS TO ARDS, WHICH IS ASSOCIATED WITH A SIGNIFICANTLY INCREASED RISK OF IN-HOSPITAL MORTALITY. THERE IS CURRENTLY NO SPECIFIC TREATMENT FOR SEPSIS-INDUCED ARDS. MOREOVER, RESEARCHERS HAVE NOT YET ELUCIDATED THE MULTIFACTORIAL MECHANISMS BY WHICH SEPSIS INDUCES ARDS, OR WHY THE INFLAMMATORY CYTOKINE STORM EVENTUALLY INDUCES DIFFUSE ALVEOLAR DAMAGE AND SEVERE HYPOXIA. THOUGH ADVANCES IN TREATMENT MODALITIES HAVE IMPROVED THE OUTCOME OVER RECENT DECADES, INCLUDING LUNG PROTECTIVE VENTILATION, PRONE POSITIONING, USE OF NEUROMUSCULAR BLOCKADE, AND EXTRACORPOREAL MEMBRANE OXYGENATION, THE MORTALITY RATE STILL REMAINS HIGH. THERE REMAINS A CRITICAL UNMET NEED FOR THE DEVELOPMENT OF SAFE AND EFFICACIOUS THERAPEUTICS TO PREVENT THE ONSET OF SEPSIS-INDUCED ARDS, PROTECT AGAINST LUNG INJURY AND IMPROVE SURVIVAL. CMTX BIOTECH IS WORKING TO DEVELOP AND COMMERCIALIZE A NOVEL AND PROPRIETARY NANOFORMULATION OF INCYCLINIDE (NCMT-3) THAT CAN BE AEROSOLIZED, AND WHICH CAN BE DELIVERED TO SPECIFICALLY TARGET THE LUNG AND TREAT SEPSIS- INDUCED ARDS WHILE LIMITING SYSTEMIC TOXICITY. INCYCLINIDE IS A CLINICAL-STAGE, NON-ANTIBIOTIC, CHEMICALLY-MODIFIED TETRACYCLINE THAT BELONGS TO A CLASS OF PLEIOTROPIC MATRIX METALLOPROTEINASE (MMP) MODULATORS WHICH INHIBIT PATHOLOGICALLY-EXCESSIVE COLLAGENOLYSIS AND RESOLVE SYSTEMIC INFLAMMATION. IMPORTANTLY, THE SAFETY OF INCYCLINIDE HAS ALREADY BEEN DEMONSTRATED IN INVESTIGATIONAL NEW DRUG (IND)-ENABLING STUDIES, AND INCYCLINIDE HAS BEEN EVALUATED IN A NUMBER OF HUMAN CLINICAL TRIALS FOR THE TREATMENT OF DISEASES AS DISPARATE AS AIDS-RELATED KAPOSI’S SARCOMA, RECURRENT HIGH-GRADE GLIOMAS, REFRACTORY METASTATIC CANCER, ACNE, ROSACEA AND PERIODONTITIS. PUBLISHED PRE-CLINICAL EFFICACY STUDIES HAVE SHOWN THAT SYSTEMIC ADMINISTRATION OF INCYCLINIDE PREVENTS THE DEVELOPMENT OF ARDS AND SEPTIC SHOCK, AND IMPROVES SURVIVAL IN SEVERAL CHRONIC INSIDIOUS ONSET ANIMAL MODELS OF ARDS ACROSS SEVERAL SPECIES, INCLUDING MICE, RATS, PIGS, AND SHEEP. OUR LONG-TERM GOAL IS TO OBTAIN REGULATORY APPROVAL FROM THE FDA AND COMPARABLE INTERNATIONAL REGULATORY AUTHORITIES TO MARKET AEROSOLIZED NCMT-3 FOR THE TREATMENT AND PREVENTION OF SEPSIS-INDUCED ARDS. WE STRONGLY ANTICIPATE THAT NCMT-3 WILL INHIBIT DISEASE PROGRESSION, MITIGATE ACUTE LUNG INJURY AND RESPIRATORY DISTRESS, REDUCE THE NEED FOR INTENSIVE CARE AND INTUBATION, AND IMPROVE CLINICAL OUTCOMES FOR SEPSIS PATIENTS, INCLUDING OVERALL SURVIVAL. OUR SPECIFIC AIMS ARE (A) TO DETERMINE THE PHARMACOKINETICS, BIODISTRIBUTION, AND SAFETY OF AEROSOLIZED NCMT-3 IN MECHANICALLY VENTILATED PIGS WITH HEALTHY LUNGS, (B) TO DEMONSTRATE THE EFFICACY OF AEROSOLIZED NCMT-3 IN REDUCING THE INCIDENCE AND MORTALITY OF SEPSIS- MEDIATED ARDS IN A HIGH-FIDELITY, CLINICALLY APPLICABLE PORCINE SEPSIS-INDUCED ARDS MODEL, AND (C) TO DEMONSTRATE THE EFFICACY OF AEROSOLIZED NCMT-3 AT REDUCING LOCAL AND SYSTEMIC INFLAMMATION. SUCCESSFUL COMPLETION OF THESE STUDIES WILL ALLOW CMTX BIOTECH TO ADVANCE NCMT-3 TOWARDS HUMAN CLINICAL TRIALS FOR THE TREATMENT OF ARDS PATIENTS.

1314098.00

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2021-02-10

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Department of Health and Human Services

REPURPOSING INCYCLINIDE FOR THE TREATMENT OF HOSPITALIZED COVID-19 PATIENTS - PROJECT SUMMARY/ABSTRACT CMTX BIOTECH IS A DRUG DEVELOPMENT COMPANY WORKING TO RESCUE AND REPURPOSE A PROPRIETARY CLINICAL-STAGE DRUG CANDIDATE, INCYCLINIDE (CMT-3 / COL-3), FOR THE TREATMENT OF PATIENTS INFECTED WITH SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS-COV-2) AND SUFFERING FROM CORONAVIRUS DISEASE 2019 (COVID-19). SINCE LATE DECEMBER 2019, AN OUTBREAK OF A NOVEL ZOONOTIC CORONAVIRUS (SARS-COV-2 / COVID-19) WITH CLINICAL PRESENTATIONS GREATLY RESEMBLING VIRAL PNEUMONIA HAS CLAIMED THE LIVES OF OVER 418,000 WORLDWIDE, INCLUDING OVER 117,000 IN THE U.S. ALONE (AS OF 6/13/2020). COVID-19 IS HIGHLY CONTAGIOUS, INFECTING OVER 7.4 MILLION PATIENTS GLOBALLY SO FAR, WITH AN AVERAGE INCUBATION PERIOD OF 4 DAYS. FREQUENTLY REPORTED COVID-19 SYMPTOMS INCLUDE FEVER, COUGH, MYALGIA OR FATIGUE, AND SHORTNESS OF BREATH. APPROXIMATELY 20-30% OF HOSPITALIZED COVID- 19 PATIENTS HAVE REQUIRED INTENSIVE CARE FOR RESPIRATORY SUPPORT. COVID-19 CAN LEAD TO ACUTE LUNG INJURY, ARDS, MULTIPLE ORGAN FAILURE AND DEATH. STUDIES HAVE SHOWN THAT COVID-19 HAS A MORTALITY RATE OF UP TO 4.2%. PREDICTORS OF FATAL OUTCOMES INCLUDE AGE, THE PRESENCE OF UNDERLYING DISEASES OR SECONDARY INFECTION, AS WELL AS ELEVATED INFLAMMATORY INDICATORS IN THE BLOOD, AND MORTALITY MAY BE DUE TO VIRUS-ACTIVATED “CYTOKINE STORM SYNDROME” OR FULMINANT MYOCARDITIS. THERE IS CURRENTLY NO VACCINE FOR COVID-19, AND ONLY REMDESIVIR (GILEAD SCIENCES) HAS SHOWN EFFICACY IN A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL, ALONG WITH EMERGENCY USE AUTHORIZATION FROM THE FDA. CLINICAL MANAGEMENT OF COVID-19 PATIENTS INCLUDES PROMPT IMPLEMENTATION OF RECOMMENDED INFECTION PREVENTION AND CONTROL MEASURES, AS WELL AS SUPPORTIVE MANAGEMENT OF COMPLICATIONS, INCLUDING MECHANICAL VENTILATION AND ADVANCED ORGAN SUPPORT. CMTX BIOTECH IS WORKING TO REPURPOSE AND COMMERCIALIZE INCYCLINIDE AS A ONCE-DAILY, ORALLY-ADMINISTERED TREATMENT FOR HOSPITALIZED COVID- 19 PATIENTS. INCYCLINIDE IS A CLINICAL-STAGE, NON-ANTIBIOTIC, CHEMICALLY-MODIFIED TETRACYCLINE THAT BELONGS TO A CLASS OF PLEIOTROPIC MATRIX METALLOPROTEINASE (MMP) MODULATORS WHICH INHIBIT PATHOLOGICALLY-EXCESSIVE COLLAGENOLYSIS AND RESOLVE SYSTEMIC INFLAMMATION. TWO RECENT INDEPENDENT STUDIES PERFORMED IN SILICO HAVE SUGGESTED THAT INCYCLINIDE MAY HAVE SIGNIFICANT THERAPEUTIC BENEFIT IN PATIENTS WITH COVID-19. IMPORTANTLY, THE SAFETY OF INCYCLINIDE HAS ALREADY BEEN DEMONSTRATED IN INVESTIGATIONAL NEW DRUG (IND)-ENABLING STUDIES, AND INCYCLINIDE HAS BEEN EVALUATED IN A NUMBER OF HUMAN CLINICAL TRIALS FOR THE TREATMENT OF DISEASES AS DISPARATE AS AIDS- RELATED KAPOSI'S SARCOMA, RECURRENT HIGH-GRADE GLIOMAS, REFRACTORY METASTATIC CANCER, ACNE, ROSACEA AND PERIODONTITIS. PUBLISHED PRE-CLINICAL EFFICACY STUDIES HAVE SHOWN THAT SYSTEMIC ADMINISTRATION OF INCYCLINIDE PREVENTS THE DEVELOPMENT OF ARDS AND SEPTIC SHOCK, AND IMPROVES SURVIVAL IN SEVERAL CHRONIC INSIDIOUS ONSET ANIMAL MODELS OF ARDS ACROSS SEVERAL SPECIES, INCLUDING MICE, RATS, PIGS, AND SHEEP. OUR LONG-TERM GOAL IS TO OBTAIN EMERGENCY USE AUTHORIZATION (EUA) AND REGULATORY APPROVAL FROM THE FDA TO MARKET INCYCLINIDE FOR THE SAFE AND EFFECTIVE TREATMENT OF COVID-19 PATIENTS, AS WELL AS TO ESTABLISH A PARTNERSHIP WITH A PHARMACEUTICAL COMPANY IN THE FORM OF A LICENSE OR ACQUISITION. WE STRONGLY ANTICIPATE THAT INCYCLINIDE WILL INHIBIT COVID-19 DISEASE PROGRESSION, MITIGATE ACUTE LUNG INJURY AND RESPIRATORY DISTRESS, REDUCE THE NEED FOR INTENSIVE CARE AND INTUBATION, AND IMPROVE CLINICAL OUTCOMES FOR COVID-19 PATIENTS, INCLUDING OVERALL SURVIVAL. OUR SPECIFIC AIMS ARE TO DESIGN A PHASE II CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF INCYCLINIDE FOR THE TREATMENT OF HOSPITALIZED COVID-19 PATIENTS, DEVELOP A PRE-IND BRIEFING DOCUMENT INCLUSIVE OF A CLINICAL STUDY SYNOPSIS, AND ENGAGE THE FDA IN A PRE-IND MEETING. MOREOVER, WE INTEND TO PREPARE KEY CLINICAL STUDY DOCUMENTS,

315000.00

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