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Details:
MTP-131 (elamipretide) is an investigational mitochondrial-targeting peptide agent, which is being evaluated for the treatment of patients with barth syndrome.
Lead Product(s): Elamipretide
Therapeutic Area: Rare Diseases and Disorders Product Name: MTP-131
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 2024
Details:
MTP-131 (elamipretide) is an investigational mitochondrial protective agent which is readily penetrates cell membranes and transiently localizes to the inner membrane of the mitochondria where it interacts with cardiolipin and investigated in Patients with Dry AMD.
Lead Product(s): Elamipretide
Therapeutic Area: Ophthalmology Product Name: MTP-131
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 12, 2023
Details:
Pharmanovia will commercialize MTP-131 (elamipretide), an investigational mitochondrial protective agent, in Europe for the treatment of Barth syndrome, an ultra-rare cardiac condition caused by mitochondrial cardiolipin deficiency for which there are no approved treatments.
Lead Product(s): Elamipretide
Therapeutic Area: Rare Diseases and Disorders Product Name: MTP-131
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Pharmanovia
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement May 30, 2023
Details:
ReCLAIM-2 analyses demonstrate that MTP-131 (elamipretide) ameliorated progressive decline, or attenuation, of the mitochondrial rich ellipsoid zone layer of photoreceptors and showed a categorical >2-line improvement in low luminance visual acuity in patients with GA.
Lead Product(s): Elamipretide
Therapeutic Area: Ophthalmology Product Name: MTP-131
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 23, 2022
Details:
MTP-131 (elamipretide), is a peptide compound that readily penetrates cell membranes, and targets the inner mitochondrial membrane where it binds reversibly to cardiolipin.
Lead Product(s): Elamipretide
Therapeutic Area: Genetic Disease Product Name: MTP-131
Highest Development Status: Phase IProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2022
Details:
Elamipretide has been shown to improve frataxin levels in Friedreich's ataxia patient-derived cells and to improve frataxin levels and motor and cardiac function in an animal model of Friedreich's ataxia.
Lead Product(s): Elamipretide
Therapeutic Area: Genetic Disease Product Name: MTP-131
Highest Development Status: Phase I/ Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 28, 2022
Details:
Results from the 7-week study demonstrated that the combination of weekly PMO and daily MTP-131 (elamipretide) therapies produced more than double the mean level of dystrophin protein in muscles of affected mice compared to treatment with PMO alone.
Lead Product(s): Elamipretide
Therapeutic Area: Genetic Disease Product Name: MTP-131
Highest Development Status: IND EnablingProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2022
Details:
Presentation will show, preclinical data demonstrating MTP-131 (elamipretide), effect in models of ophthalmic disease in addition to clinical data showing that degree of baseline function may predict therapeutic response in patients with dry AMD.
Lead Product(s): Elamipretide
Therapeutic Area: Ophthalmology Product Name: MTP-131
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2022
Details:
Final patient in ReCLAIM-2 phase 2 clinical trial of MTP-131 for extra-foveal GA associated with dry AMD has completed treatment, demonstrated improvement from baseline in low-light visual function and a lower-than-expected rate of GA progression in Phase 1 clinical trial.
Lead Product(s): Elamipretide
Therapeutic Area: Ophthalmology Product Name: MTP-131
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 15, 2022
Details:
MTP-131 (Elamipretide), new data anaylsis showed significantly increased dystrophin expression in muscle to almost twice the level, which may help in addressing the unmet need for therapies in DMD.
Lead Product(s): Elamipretide,Phosphorodiamidate Morpholino Oligomer
Therapeutic Area: Genetic Disease Product Name: MTP-131
Highest Development Status: PreclinicalProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 13, 2021
Details:
U.S. Patent were granted on August 10, 2021, and include claims for the administration of elamipretide for treating Barth syndrome and Barth syndrome-related cardiomyopathy, respectively.
Lead Product(s): Elamipretide
Therapeutic Area: Genetic Disease Product Name: MTP-131
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 23, 2021
Details:
TAZPOWER is a randomized, double-blind, placebo-controlled phase 2/3 crossover study to evaluate the safety, tolerability and efficacy of 12 weeks’ treatment with daily subcutaneous injections of elamipretide in individuals with genetically confirmed Barth syndrome.
Lead Product(s): Elamipretide
Therapeutic Area: Genetic Disease Product Name: MTP-131
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2021
Details:
ReCLAIM-2 is a phase 2 randomized, double-masked, placebo-controlled study to evaluate the efficacy and pharmacokinetics of elamipretide in patients with dry age-related macular degeneration (AMD) with geographic atrophy (GA).
Lead Product(s): Elamipretide
Therapeutic Area: Ophthalmology Product Name: Bendavia
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 23, 2021
Details:
The Company intends to use the net proceeds from this offering to fund the continued clinical development of elamipretide and for working capital and general corporate purposes.
Lead Product(s): Elamipretide
Therapeutic Area: Rare Diseases and Disorders Product Name: MTP-131
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: H.C. Wainwright & Co
Deal Size: $4.7 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 10, 2021
Details:
DCN suggested that, based on the short half-life of elamipretide, a short-term withdrawal period could be sufficient to measure durable effect on functional or structural cardiac endpoints by demonstrating that improvement is not dependent on continuous exposure to the drug.
Lead Product(s): Elamipretide
Therapeutic Area: Rare Diseases and Disorders Product Name: MTP-131
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 06, 2021
Details:
The agreement will enable company's clinical development of elamipretide, Phase 2b study in geographic atrophy and prepare to file our first NDA for elamipretide for the treatment of Barth syndrome.
Lead Product(s): Elamipretide
Therapeutic Area: Ophthalmology Product Name: MTP-131
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Morningside Ventures
Deal Size: $35.0 million Upfront Cash: Undisclosed
Deal Type: Financing November 04, 2020
Details:
The poster titled "TAZPOWER Analysis: Elamipretide Significantly Improves Disease Symptomatology versus Natural History Controls in Barth Syndrome," shows the importance of longitudinal natural history data in understanding and validating clinical trial outcomes for Barth.
Lead Product(s): Elamipretide
Therapeutic Area: Genetic Disease Product Name: MTP-131
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 19, 2020
Details:
Stealth BioTherapeutics is eligible for a voucher that can be used to obtain priority review for a subsequent human drug application.
Lead Product(s): Elamipretide
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 03, 2020
Details:
Elamipretide achieves statistical significance on key secondary endpoints
Lead Product(s): Elamipretide
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 18, 2020
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