BiologicsMD is an early stage, therapeutic research and development company focused on developing highly-targeted, human therapeutics and therapeutic-device combinations for the treatment of bone and hair-loss disorders.
The Company’s core technology relies on targeting physiologically active agents to Type I collagen, found in bone and skin, via fusion to a proprietary collagen-binding domain. BiologicsMD has developed a series of recombinant fusion proteins that specifically target the parathyroid hormone (PTH) receptor pathway with sustained activity at a low total dose (bioactive for a period of months from a single application). Importantly, for the lead indications of spinal fusion and fracture repair, targeting the PTH receptor pathway activates multiple components of bone formation and remodeling, providing a more complete repair response than other osteobiologic agents. BiologicsMD’s approach minimizes off-target effects (e.g. hypercalcemia and kidney stones) and increases the time of exposure at the targeted sites, thereby reducing both the frequency of dosing and the total amount of drug required.
BiologicsMD’s lead program, BMD-1231, is a therapeutic-device combination that has a proven and potent profile in bone osteogenesis, and is being developed to facilitate spinal fusions in degenerative disk disease and reduce the number of incomplete fusions (pseudarthrosis). Despite current surgical techniques and advanced surgical hardware, further clinical advances are needed to reduce the number of incomplete unions, provide faster fracture healing, and greatly reduce the need for secondary interventions and additional surgeries. The company is initially focusing on spinal fusion surgical procedures to aid in the complete fusion of the targeted vertebrae, which currently has only a 70-75% success rate with the first surgery.
Products / Services
BMD-1231 is a bone graft substitute that includes (i) recombinant PTH-CBD which is a fusion of PTH(1-33) to a collagen binding domain (CBD) from ColH collagenase and (ii) a ß-tricalcium phosphate and collagen putty used for spinal fusion procedures in lieu of autologous bone grafts. The osteogenic and bone-remodeling effects of the PTH-CBD protein have been demonstrated to last 4-6 months from a single dose in rodent models. The protein manufacturing process is nearing completion and the program is in pre-IDE development.
BMD-2341 is a topical formulation of the agonist PTH-PKD-CBD, and is being developed to facilitate hair growth in alopecia areata and other hair-loss disorders. PTH-PKD-CBD binds more tightly to collagen, and when applied topically, remains resident in the dermal layer, stimulating the anagen (growth) phase of the hair cycle. Efficacy has been demonstrated in animal models of chemotherapy-induced alopecia and alopecia areata. The program is in the formulation development stage.
BMD-3151 is a subcutaneous injection of the PTHrP antagonist, PTH(7-33)-CBD, and is being studied for the prevention and treatment of breast cancer metastasis to the bone. The program is in early preclinical development with preclinical animal efficacy data suggesting that the compound will prevent breast cancer bone metastases.
BMD-1111 is the subcutaneous injection of the agonist, PTH-CBD, for the treatment of post-menopausal osteoporosis. Efficacy lasting >6 months has been demonstrated for a single injection in the ovarectomized rat model. The program is in the preclinical toxicology phase working towards IND filing, and is on hold pending market developments in the osteoporosis drug space.