Stealth BioTherapeutics

MA - Needham

Biotechnology

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Focus: Mitochondrial disease therapies

Stealth BioTherapeutics is a life sciences company focused on Mitochondrial disease therapies.

UnknownRare Diseases

Funding Stage

PUBLIC

Open Jobs

7

Products & Portfolio (1)

elamipretide hydrochloride

SUBCUTANEOUS · SOLUTION

12.1 Mechanism of Action FORZINITY is a mitochondrial cardiolipin binder that localizes to the inner mitochondrial membrane and improves mitochondrial morphology and function. 12.2 Pharmacodynamics Effects on QTc Interval Cardiac electrophysiology Clinically significant QTc interval prolongation was not observed at 3 times the peak concentration of the maximum recommended FORZINITY dose. 12.3 Pharmacokinetics Elamipretide exposure increases proportionally over a dose range of 2 to 80 mg following daily subcutaneous injections with minimal accumulation. Absorption Maximum elamipretide concentrations were reached between 0.5 to 1 hour after subcutaneous administration. The absolute bioavailability following subcutaneous administration is approximately 92%. FORZINITY exposure is comparable after subcutaneous injection to the thigh or to the abdomen. Distribution Elamipretide is distributed throughout total body water with an approximate volume of distribution of 0.5 L/kg. There is low binding to plasma proteins (approximately 39%). Elimination Metabolism Elamipretide is metabolized via sequential C-terminal degradation to the M1 tripeptide and M2 dipeptide metabolites, which do not have pharmacological activity. Excretion Elamipretide and its metabolites M1 and M2 are excreted in the urine. At 48 hours post-dose, approximately 100% of the FORZINITY dose was recovered in the urine as either elamipretide, M1, or M2 in patients with normal renal function. Specific Populations Patients with Renal Impairment Elamipretide exposure (AUC) increased by 39% in subjects with creatinine clearance 60 to 89 mL/min, 75% in subjects with creatinine clearance 30 to 59 mL/min, and 125% in subjects with creatinine clearance less than 30 mL/min not on dialysis. Renal impairment was categorized based on 24-hour measured urinary creatinine clearance. There was minimal accumulation of elamipretide with daily dosing, regardless of the severity of renal impairment. There was a significant increase in exposure of the M1 and M2 metabolites, up to 280% and 640%, respectively, in subjects with severe renal impairment not on dialysis (creatinine clearance less than 30 mL/min). While the effect of renal impairment on elamipretide pharmacokinetics was characterized using 24-hour measured urinary creatinine clearance, analyses conducted with estimated glomerular filtration (CKD-EPI equation) support the recommendations for use in this specific population [see and ] . Patients with Hepatic Impairment No hepatic metabolism was observed for elamipretide in vitro. Hepatic impairment is not expected to alter the pharmacokinetics (PK) of elamipretide. Drug Interaction Studies In Vitro Studies CYP enzymes: Elamipretide does not inhibit CYP1A, CYP2D6, CYP2E1, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP3A. Elamipretide does not induce metabolism by CYP1A2, CYP2B6, or CYP3A4. Drug transporters: Elamipretide does not inhibit the activity of OCT2, BCRP, OAT1, OAT3, OATP1B1, OATP1B3, P-gp, or MATE2

muscle strength in adult

Open Jobs (7)

Regional Account Manager – Mitochondria, Midwest

Midwest Region (preferably residing in OH, MI, MN, MO, WI, NE)

$100K - $120K/yr

Regional Account Manager – Mitochondria, West Coast

Regional Account Manager – Mitochondria, Mid-Atlantic

Regional Account Manager – Mitochondria, Northeast

Director/Sr. Director, Program Management

Program Management

Director/Sr. Director, Clinical Operations

Clinical Operations

Contracts Attorney

Interview Prep Quick Facts

Portfolio: 1 approved product

Open Roles: 7 active jobs

Portfolio Health

Launch1 (100%)

1 total products