Antiaging Treatments that are Closest to FDA Approval

There are a few dozen antiaging rejuvenation treatments that are progressing through pre-clinical and clinical trials.

Lifespan.io is tracking the antiaging rejuvenation treatments on a rejuvenation roadmap.

Two treatments are in phase 3 clinical trial.

Samumed is developing drugs for multiple degenerative diseases, including osteoarthritis, alopecia (baldness), and degenerative disc disease. While these therapies differ from each other, they all focus on restoring the Wnt signaling pathway. Samumed has multiple therapies in human clinical trials, two of which have returned positive results from Phase 2 testing. If these therapies succeed in Phase 3 trials and are found to be effective in clinical practice, they will demonstrate the viability of targeting signaling pathways, potentially paving the way for a broad range of similar therapies. In 2018, Samumed raised $438 million in funding.

Mitotech S.A, based in Luxembourg, is developing SkQ1, a powerful antioxidant that directly targets mitochondria.

There are ten antiaging rejuvenation treatments in phase 2 clinical trials.

UNITY is a biotech company working on the removal of senescent cells, which accumulate with age, drive chronic inflammation, and spur various age-related diseases. UBX0101, is designed to treat musculoskeletal disease, with an initial focus on osteoarthritis. The candidate is a uniquely senolytic small molecule inhibitor of the MDM2/p53 protein interaction. Disruption of this protein interaction triggers the destruction of senescent cells.

The Mayo Clinic, in partnership with the Scripps Research Institute, has discovered a combination of drugs (dasatinib and quercetin) that destroy harmful senescent cells, greatly increasing healthspan in a mouse model. These drugs, called senolytics, offer a novel method of treating age-related diseases.

University of Minnesota Medical School faculty member Paul D. Robbins and Laura J. Niedernhofer and Mayo Clinic investigators James L. Kirkland and Tamara Tchkonia published “Fisetin is a senotherapeutic that extends health and lifespan” in the journal EBioMedicine in October 2018 Fisetin is undergoing human clinical trials to test its ability to remove harmful senescent cells which accumulate with age. A phase 2 study to address age-related frailty was conducted from February 2018 to December 2019 with some positive initial results.

Dr. Greg Fahy has been working on rejuvenation of the thymus for a number of years, and, in 2015, conducted a small-scale human trial to see if the earlier results in animals would translate to people. Human growth hormone (HGH) and dehydroepiandrosterone (DHEA) are in phase 2 to see if they can regrow the thymus.

In 2017 a phase 2 clinical trial for Mesenchymal stem cell (MSCs) therapy to treat age-related frailty was launched.

Longeveron is developing allogeneic human mesenchymal stem cells (MSCs) for a variety of diseases, some of which are age-related. Currently, the company is in multiple clinical trial stages with its flagship product, including a phase 2b trial for frailty, a phase 1 trial for Alzheimer’s disease, a phase 1/2 trial for vaccine immune response, a phase 2b trial for metabolic syndrome, and a phase 1/2 trial for hypoplastic left heart syndrome in infants to be given alongside standard heart surgery.

Rejenevie Therapeutics is developing a heterochronic cell culture model in order to stimulate the function of hematopoietic stem cells (HSCs). The goal is to promote the rejuvenation of aging cells by providing them with youthful blood factors, a technique that is related to parabiosis, the connection of old and young vascular systems.

Stealth BioTherapeutics is investigating the potential of elamipretide, a drug that has been shown to bind to the inner mitochondrial membrane, aiding in mitochondrial respiration and ATP production while protecting against reactive oxygen species (ROS). A phase 3 trial did not achieve desired results but they are still working on it.

ResTORbio, Inc. is developing RTB101, an oral medication that inhibits target of rapamycin complex 1 (TORC1). Concluding the successful Phase 2 and 2b studies the company has agreed with the FDA to proceed to a large scale phase 3 clinical trial scheduled to begin later in 2019. On Friday 15th November 2019, resTORbio announced that the phase 3 trial had failed to meet its primary goal for the reduction of respiratory tract infections in people aged 65 and older. This is a setback for the approach. They are continuing to test the drug for other age-related diseases including Parkinson’s and the company expects to release data from its mid-stage Parkinson’s trial in mid-2020.

Alkahest is currently developing multiple therapies based on these plasma fractions. AKST4290 is in a phase 2 trial for macular degeneration and will soon be in phase 2 trials for neurodegenerative disease and inflammatory disease. GRF6019 and GRF6021 are in phase 2 trials for neurodegenerative diseases, including Parkinson’s and Alzheimer’s,

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