CBP-4888 / Comanche Biopharma - LARVOL DELTA

CUREPE-01 (CBP-4888 Use to tREat PreEclampsia): A study to investigate the safety, pharmacodynamic and pharmacokinetic characteristics of CBP-4888 in hospitalized participants with preterm preeclampsia and the safety and tolerability of CBP-4888 on their children. (ANZCTR) - P1 | N=60 | Not yet recruiting | Sponsor: Comanche Biopharma (AU) Pty Ltd

New P1 trial • Gynecology

Study of CBP-4888 in Healthy, Non-Pregnant Female Subjects (clinicaltrials.gov) - P1 | N=45 | Completed | Sponsor: Comanche Biopharma | Recruiting ➔ Completed | N=15 ➔ 45

Enrollment change • Trial completion

Comanche Biopharma Announces European Medicines Agency (EMA) Has Granted Orphan Drug Designation for CBP-4888 in sFlt1-mediated Preterm Preeclampsia (GlobeNewswire) - "Comanche Biopharma Corp. today announced that the European Medicines Agency (EMA) has granted orphan drug designation for CBP-4888 for the treatment of sFlt1-mediated preterm preeclampsia. A serious obstetric complication, preeclampsia is estimated to impact approximately four in 10,000 pregnancies in the European Union each year. A novel siRNA drug candidate, CBP-4888 is designed to downregulate overexpression of the protein sFlt1, a known pathogenic mediator of preeclampsia, in the placenta. Currently an investigational drug candidate, CBP-4888 has the potential to be the first precision medicine for an obstetrical indication."

Orphan drug • Women's Health

Comanche Biopharma Awarded Innovation Passport Designation by the U.K. Innovative Licensing and Access Pathway (ILAP) Steering Group for CBP-4888, an Investigational siRNA Drug Candidate for the Treatment of sFlt1-mediated Preterm Preeclampsia (GlobeNewswire) - "Comanche Biopharma Corp. today announced that the U.K. Innovative Licensing and Access Pathway (ILAP) Steering Group has awarded an Innovation Passport to CBP-4888, Comanche Biopharma’s investigational drug candidate for the treatment of sFlt1-mediated preterm preeclampsia....We look forward to collaborating with U.K. regulators to help accelerate the development of this important therapeutic for pregnant patients..."

European regulatory • Hypertension • Women's Health

Gene therapy in preeclampsia: the dawn of a new era. (PubMed, Hypertens Pregnancy) - "Notably, CBP-4888, a siRNA drug delivered subcutaneously to knock down sFLT1 expression in the placenta, has recently obtained Fast Track approval from the Food and Drug Administration (FDA) and is undergoing a phase 1 clinical trial. Such advance highlights a growing interest and significant potential in gene therapy to manage preeclampsia. This review summarizes the advances and prospects of gene therapy in treating placental dysfunction and illustrates crucial challenges and considerations for these emerging treatments."

Gene therapy • Journal • Review • Cardiovascular • CNS Disorders • Epilepsy • Gene Therapies • Gynecology • Hypertension • FLT1

Study of CBP-4888 in Healthy, Non-Pregnant Female Subjects (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Comanche Biopharma | Trial completion date: Dec 2023 ➔ Apr 2024 | Trial primary completion date: Nov 2023 ➔ Mar 2024

Trial completion date • Trial primary completion date

Study of CBP-4888 in Healthy, Non-Pregnant Female Subjects (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Comanche Biopharma | Trial completion date: Aug 2023 ➔ Dec 2023 | Trial primary completion date: Jul 2023 ➔ Nov 2023

Trial completion date • Trial primary completion date

Study of CBP-4888 in Healthy, Non-Pregnant Female Subjects (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Comanche Biopharma

New P1 trial