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HEALTH CENTER CLUSTER

LONG-ACTING PTH FOR HYPOPARATHYROIDISM

VA IS PROVIDING PER DIEM FUNDING TO ASSIST WITH THE OPERATIONAL COSTS ASSOCIATED WITH TRANSITIONAL HOUSING BEDS FOR HOMELESS VETERANS.

LONG-ACTING GHRELIN FOR THE TREATMENT OF CANCER CACHEXIA

LONG-ACTING PTH FOR HYPOPARATHYROIDISM - PROJECT SUMMARY HYPOPARATHYROIDISM IS A RARE DISEASE THAT RESULTS FROM A DEFICIENCY OR INABILITY TO MAKE SUFFICIENT AMOUNTS OF PARATHYROID HORMONE (PTH). UNTREATED OR INADEQUATELY TREATED HYPOPARATHYROIDISM LEADS TO CLINICALLY SIGNIFICANT MINERAL-RELATED METABOLIC ISSUES INCLUDING HYPOCALCEMIA, WHICH LEADS TO HEART ARRHYTHMIAS, SPASMS OF THE VOCAL CORDS, AND SEIZURES. CURRENT MANAGEMENT OF THE DISEASE FOR THE MAJORITY OF PATIENTS CONSISTS OF SUPPLEMENTAL DOSES OF CALCIUM AND ACTIVE VITAMIN D TO MANAGE THE HYPOCALCEMIA. WHILE THIS APPROACH IS INTENDED TO MAINTAIN SERUM CALCIUM, IT DOES NOT CORRECT THE UNDERLYING PTH DEFICIENCY AND THE PHYSIOLOGICAL ASPECTS OF HYPOPARATHYROIDISM CAN STILL OCCUR. MOREOVER, SUPPLEMENTATION IS ASSOCIATED WITH LONG-TERM COMPLICATIONS FROM THE USE OF SUPRAPHYSIOLOGICAL DOSES OF CALCIUM IN THE ABSENCE OF ENDOGENOUS PTH HORMONE, WHICH CONTRIBUTE TO RENAL FUNCTION DETERIORATION, KIDNEY STONES, SOFT TISSUE CALCIFICATIONS AND ABNORMALITIES IN BONE REMODELING. NATPARA (PTH 1-84), IS APPROVED BY THE FDA FOR A SUBSET OF HYPOPARATHYROIDISM PATIENTS, BUT ONLY PARTIALLY ALLEVIATES THE NEED FOR VITAMIN SUPPLEMENTATION DUE TO ITS SHORT HALF-LIFE, AND SOME PATIENTS STILL MUST TAKE >10 PILLS/DAY. CLINICAL TRIALS HAVE DEMONSTRATED THAT IF PTH(1-34) IS DOSED CONTINUOUSLY VIA A PUMP IN HUMANS, IT CAN MIMIC PHYSIOLOGICAL LEVELS OF PTH TO RESTORE NORMAL LEVELS OF CALCIUM, PHOSPHORUS AND MARKERS OF BONE TURNOVER. HOWEVER, A PUMP-MEDIATED, CONTINUOUS INFUSION OF PTH WOULD BE COSTLY AND INCONVENIENT FOR PATIENTS. EXTEND BIOSCIENCES HAS DEVELOPED A LONG-ACTING VERSION OF PTH(1-34) (EXT608) THAT COULD BE DOSED ONCE A WEEK AND ACHIEVE A PROLONGED PHARMACOKINETIC PROFILE THAT APPROXIMATES ENDOGENOUS PTH LEVELS. SBIR PHASE II RESULTS SHOWED THAT EXT608 IS MORE EFFICACIOUS THAN NATIVE PTH, AND BASED ON THE RETENTION TIME IN RAT AND NHP, EXT608 IS PROJECTED TO BE DOSED ONCE-WEEKLY IN HUMANS. IN OUR ONGOING PHASE 1 CLINICAL TRIAL IN HEALTHY VOLUNTEERS, THE DRUG HAS BEEN WELL TOLERATED WITH NO ADVERSE EVENTS. THE STUDIES PROPOSED IN THIS DIRECT TO PHASE II APPLICATION WILL FOCUS ON A SECOND CLINICAL STUDY IN HEALTHY VOLUNTEERS LOOKING AT THE EFFECT OF MULTIPLE DOSES. WE WILL BEGIN A PHASE 2 CLINICAL TRIAL TO DETERMINE SAFETY AND TOLERABILITY OF EXT608 IN PATIENTS FOLLOWING THIS STUDY. THIS LONG-ACTING PTH(1-34) DERIVATIVE WILL PROVIDES A TRUE REPLACEMENT THERAPY TO TREAT HYPOPARATHYROIDISM THAT RETURNS SERUM AND URINARY CALCIUM AND PHOSPHATE TO PHYSIOLOGICAL LEVELS THAT WILL SIGNIFICANTLY IMPROVE THE QUALITY OF LIFE FOR PATIENTS.

A PHASE 2 STUDY INVESTIGATING THE SAFETY, TOLERABILITY AND EFFICACY OF EXT608 IN ADULTS WITH HYPOPARATHYROIDISM (IND146180; OCTOBER 14, 2022) - PROJECT SUMMARY HYPOPARATHYROIDISM IS A RARE DISEASE THAT RESULTS FROM A DEFICIENCY OR INABILITY TO MAKE SUFFICIENT AMOUNTS OF PARATHYROID HORMONE (PTH). UNTREATED OR INADEQUATELY TREATED HYPOPARATHYROIDISM LEADS TO CLINICALLY SIGNIFICANT MINERAL-RELATED METABOLIC ISSUES INCLUDING HYPOCALCEMIA, WHICH LEADS TO HEART ARRHYTHMIAS, SPASMS OF THE VOCAL CORDS, AND SEIZURES. CURRENT MANAGEMENT OF THE DISEASE FOR THE MAJORITY OF PATIENTS CONSISTS OF SUPPLEMENTAL DOSES OF CALCIUM AND ACTIVE VITAMIN D TO MANAGE THE HYPOCALCEMIA. WHILE THIS APPROACH IS INTENDED TO MAINTAIN SERUM CALCIUM, IT DOES NOT CORRECT THE UNDERLYING PTH DEFICIENCY AND THE PHYSIOLOGICAL ASPECTS OF HYPOPARATHYROIDISM CAN STILL OCCUR. MOREOVER, SUPPLEMENTATION IS ASSOCIATED WITH LONG-TERM COMPLICATIONS FROM THE USE OF SUPRAPHYSIOLOGICAL DOSES OF CALCIUM IN THE ABSENCE OF ENDOGENOUS PTH HORMONE, WHICH CONTRIBUTE TO RENAL FUNCTION DETERIORATION, KIDNEY STONES, SOFT TISSUE CALCIFICATIONS AND ABNORMALITIES IN BONE REMODELING. NATPARA (PTH 1-84), WAS APPROVED BY THE FDA FOR A SUBSET OF HYPOPARATHYROIDISM PATIENTS, BUT ONLY PARTIALLY ALLEVIATES THE NEED FOR VITAMIN SUPPLEMENTATION DUE TO ITS SHORT HALF-LIFE, AND IT WAS RECENTLY ANNOUNCED THAT MANUFACTURING WILL CEASE IN 2024. CLINICAL TRIALS HAVE DEMONSTRATED THAT IF PTH(1-34) IS DOSED CONTINUOUSLY VIA A PUMP IN HUMANS, IT CAN MIMIC PHYSIOLOGICAL LEVELS OF PTH TO RESTORE NORMAL LEVELS OF CALCIUM, PHOSPHORUS AND MARKERS OF BONE TURNOVER. HOWEVER, A PUMP-MEDIATED, CONTINUOUS INFUSION OF PTH WOULD BE COSTLY AND INCONVENIENT FOR PATIENTS. EXTEND BIOSCIENCES HAS DEVELOPED A LONG-ACTING VERSION OF PTH(1-34) (EXT608) THAT ACHIEVES A PROLONGED PHARMACOKINETIC PROFILE THAT APPROXIMATES ENDOGENOUS PTH LEVELS. BASED ON AN INTERIM DATA ANALYSIS OF PHASE 1 RESULTS PRIOR TO DATABASE LOCK, EXT608 WAS SAFE AND WELL-TOLERATED AND IS PROJECTED TO BE DOSED ONCE-WEEKLY IN HUMANS. THE STUDIES PROPOSED IN THIS GRANT APPLICATION WILL FOCUS ON A PHASE 2 DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL IN PATIENTS. THIS TRIAL WILL HELP DEMONSTRATE THAT THIS LONG-ACTING PTH(1-34) DERIVATIVE IS PROVIDES A SUPERIOR PTH BASED THERAPY TO TREAT HYPOPARATHYROIDISM THAT RETURNS SERUM AND URINARY CALCIUM AND PHOSPHATE TO PHYSIOLOGICAL LEVELS AND MAINTAINS IT OVER THE COURSE OF WEEK, THEREBY SIGNIFICANTLY IMPROVING COMPLIANCE AND QUALITY OF LIFE FOR PATIENTS.

VA IS PROVIDING PER DIEM FUNDING TO ASSIST WITH THE OPERATIONAL COSTS ASSOCIATED WITH TRANSITIONAL HOUSING BEDS FOR HOMELESS VETERANS.

SBIR PHASE II: A PLATFORM TECHNOLOGY THAT SIGNIFICANTLY IMPROVES DRUG DELIVERY

VA IS PROVIDING PER DIEM FUNDING TO ASSIST WITH THE OPERATIONAL COSTS ASSOCIATED WITH TRANSITIONAL HOUSING BEDS FOR HOMELESS VETERANS.

VA IS PROVIDING PER DIEM FUNDING TO ASSIST WITH THE OPERATIONAL COSTS ASSOCIATED WITH TRANSITIONAL HOUSING BEDS FOR HOMELESS VETERANS.

LONG-ACTING GHRELIN FOR THE TREATMENT OF ARS

LONG-ACTING GHRELIN FOR NEUROPATHY

RURAL HEALTH CARE SERVICES OUTREACH GRANT PROGRAM

A SYSTEMICALLY DELIVERABLE RNAI-BASED APPROACH FOR ALCOHOLIC LIVER DISEASE

ARRA - CAPITAL IMPROVEMENT PROGRAM

ULTRALONG-ACTING INSULIN FOR DIABETES

ACCESS TRANSITIONAL HOUSING PROGRAM

LONG ACTING PTH FOR HYPOPARATHYROIDISM

LONG LASTING GHRELIN DERIVATIVES FOR THE TREATMENT OF CANCER CACHEXIA

SBIR PHASE I: DEVELOPMENT OF A PLATFORM FOR RAPID "PLUG AND PLAY" CHEMO-ENZYMATIC CONJUGATION OF BIO-THERAPEUTICS

ARRA - INCREASE SERVICES TO HEALTH CENTERS

SBIR PHASE I: CARRIERS FOR IMPROVED DRUG DELIVERY OF BIOPHARMACEUTICALS

AFFORDABLE CARE ACT (ACA) GRANTS FOR SCHOOL-BASED HEALTH CENTERS CAPITAL PROGRAM

VA IS PROVIDING PER DIEM FUNDING TO ASSIST WITH THE OPERATIONAL COSTS ASSOCIATED WITH TRANSITIONAL HOUSING BEDS FOR HOMELESS VETERANS.

REAP RENEWABLE ENERGY SYSTEM (RES) GRANT UNRESTRICTED AMOUNT

VA IS PROVIDING PER DIEM FUNDING TO ASSIST WITH THE OPERATIONAL COSTS ASSOCIATED WITH TRANSITIONAL HOUSING BEDS FOR HOMELESS VETERANS.

DIRECT COMMUNITY FACILITY LOANS

RURAL HEALTH CLINIC VACCINE CONFIDENCE PROGRAM

RURAL HEALTH CARE SERVICES OUTREACH GRANT PROGRAM