Download PDF
CC BY-NC-ND 4.0 · Drug Res (Stuttg) 2023; 73(02): 95-104
DOI: 10.1055/a-1962-6834
Original Article

A Double-blind, Placebo-controlled, Randomized, Single Ascending, and Multiple Dose Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Dose Isomyosamine Capsules in Healthy Adult Subjects

Jenna Brager
1   MyMD Pharmaceuticals, Inc. Baltimore, MD, USA
,
Chris Chapman
1   MyMD Pharmaceuticals, Inc. Baltimore, MD, USA
,
Leonard Dunn
2   Clinical Research of West Florida Clearwater, FL, USA
,
Adam Kaplin
1   MyMD Pharmaceuticals, Inc. Baltimore, MD, USA
› Author Affiliations
› Further Information
Also available at
   Permissions and Reprints

Abstract

Background Aging is tightly linked to chronic disease, frailty, and death. Multi-morbidity, defined as the presence in the same patient of three or more conditions such as neoplastic, cardiovascular, neurodegenerative, metabolic, or autoimmune diseases, becomes more common with age.

Methods The study was performed in a double-blind fashion. Subjects within each dose cohort (Cohorts 1, 2, 3, and 4) were randomly assigned to receive Isomyosamine doses (between 150 mg to 600 mg or placebo) or placebo in a 3:1 ratio (6 active: 2 placebo).

Results Isomyosamine single daily doses each of 150 mg, 300 mg, and 450 mg for 3 days and multiple daily doses of 600 mg for 6 days were safe and well tolerated in healthy subjects. In one dose group, there was a decrease in TNF-α levels found in Isomyosamine treated subjects, but no change in the levels in subjects given placebo. The increase in Isomyosamine exposure was proportional to dose across the dose range of 300 mg to 600 mg when administered as a single dose. There was minimal accumulation of Isomyosamine following 5 days of once daily dosing of Isomyosamine 600 mg. Isomyosamine half-life ranged from approximately 15 minutes to 45 minutes across all doses in the single ascending dose and multiple ascending dose portion of the study. Elimination of Isomyosamine included the renal pathway as a minor route.

Conclusion Isomyosamine will continue to be investigated in phase 2 clinical trials for the treatment of sarcopenia/frailty, hashimoto’s thyroiditis and rheumatoid arthritis.

Key words

inflammation - biomarkers - pharmacokinetics

Supplementary Material



Publication History

Received: 29 April 2022

Accepted: 15 October 2022

Article published online:
11 November 2022

© 2022. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

Georg Thieme Verlag
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

  • References

  • 1 St Sauver JL, Boyd CM, Grossardt BR, Bobo WV, Finney Rutten LJ, Roger VL. et al Risk of developing multimorbidity across all ages in an historical cohort study: differences by sex and ethnicity. BMJ Open 2015; 5: e006413
    CrossrefPubMedGoogle Scholar
  • 2 Ros M, Carrascosa JM.. Current nutritional and pharmacological anti-aging interventions. Biochim Biophys Acta Mol Basis Dis 2020; 1866: 165612
    CrossrefPubMedGoogle Scholar
  • 3 Richardson NE, Konon EN, Schuster HS, Mitchell AT, Boyle C, Rodgers AC. et al Lifelong restriction of dietary branched-chain amino acids has sex-specific benefits for frailty and lifespan in mice. Nat Aging 2021; 1: 73-86
    CrossrefPubMedGoogle Scholar
  • 4 Di Dalmazi G, Chalan P, Caturegli P.. MYMD-1, a Novel Immunometabolic Regulator, Ameliorates Autoimmune Thyroiditis via Suppression of Th1 Responses and TNF-α Release. J Immunol 2019; 202: 1350-1362
    CrossrefPubMedGoogle Scholar
  • 5 Glenn JD, Pantoja IM, Caturegli P, Whartenby KA.. MYMD-1, a novel alkaloid compound, ameliorates the course of experimental autoimmune encephalomyelitis. J Neuroimmunol 2020; 339: 577115
    CrossrefPubMedGoogle Scholar
  • 6 Brandenberger C, Mühlfeld C.. Mechanisms of lung aging. Cell Tissue Res 2017; 367: 469-480
    CrossrefPubMedGoogle Scholar
  • 7 Sabini E, O'Mahony A, Caturegli P.. MyMD-1 improves health span and prolongs lifespan in old mice: A non-inferiority study to rapamycin. J Gerontol A Biol Sci Med Sci 2022; Aug 2 glac142
    CrossrefPubMedGoogle Scholar
  • 8 MyMD pharmaceuticals' lead compound MYMD-1 shows commonality in comparative study with FDA-approved anti-inflammatory and anti-autoimmune drugs used for arthritis, colitis and Dermatitis. Business Wire. (2021, July 27). Retrieved August 6, 2022, from https://www.businesswire.com/news/home/20210727005570/en/MyMD-Pharmaceuticals%E2%80%99-Lead-Compound-MYMD-1-Shows-Commonality-in-Comparative-Study-with-FDA-Approved-Anti-Inflammatory-and-Anti-Autoimmune-Drugs-Used-for-Arthritis-Colitis-and-Dermatitis
    PubMed
  • 9 Keystone Bioanalytical, Inc. (2022). The Determination of Myridine in Human K2EDTA Plasma from a Double-blind, Placebo-controlled, Randomized, Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Dose of MyMD1™ Capsules in Healthy Male and Female Adult Subjects (Sponsor Protocol No. MyMD-PK-02). Validation Method Summary. Report No. 210508.00
    PubMed