Safety of TCMCB07, a melanocortin‐4 antagonist peptide, in dogs with naturally occurring cachexia

Author:

Axiak‐Bechtel Sandra M.1ORCID,Leach Stacey B.2ORCID,Newton‐Northup Jessica R.3,Milner Rowan J.1ORCID,Fox‐Alvarez Stacey A.1,Fagman Lana I.1,Young Kaylee A.1,Tate Deborah J.2,Wright Zachary M.4,Chretin John D.5,Allen Justin W.5ORCID,Yoshimoto Sean K.5,Selting Kimberly A.2,Flesner Brian K.2,White Carrie R.6,Mills Tracy7,Aherne Michael1ORCID,Bergman Philip J.7,Qi LeAnn3,Gruber Kenneth A.38,Callahan Michael F.8

Affiliation:

1. Department of Small Animal Clinical Sciences University of Florida Gainesville Florida USA

2. Department of Veterinary Medicine and Surgery University of Missouri Columbia Missouri USA

3. TCI Peptide Therapeutics Columbia Missouri USA

4. VCA Animal Diagnostic Clinic Dallas Texas USA

5. VCA West Los Angeles Los Angeles California USA

6. VCA Family and Oahu Veterinary Specialty Center Pearl City Hawaii USA

7. VCA Clinical Studies Los Angeles California USA

8. Department of Medical Pharmacology & Physiology and the Dalton Cardiovascular Research Center University of Missouri Columbia Missouri USA

Abstract

AbstractBackgroundThe melanocortin 4 antagonist TCMCB07 is safe and effective in reversing cachexia caused by sepsis or cancer in rodents. The safety and pharmacokinetics of TCMCB07 are demonstrated in healthy beagle dogs.Hypothesis/ObjectivesThe objectives of this study were to investigate the safety, peak plasma concentrations, and potential for efficacy of TCMCB07 in pet dogs with naturally occurring cachexia over a 4‐week time period.AnimalsFourteen dogs with cachexia of any underlying cause, except cancer of the oral cavity or gastrointestinal tract, were eligible for enrollment with informed client consent.MethodsThis study was a prospective, 1‐armed open‐label trial. Physical examination, complete blood count, chemistry panel, and owner‐assessed quality of life surveys were checked at weeks 1, 2, and 4. Due to potential for bradycardia and hypotension, Holter monitoring and blood pressure evaluations were scheduled at pre‐enrollment and week 4.ResultsFourteen dogs completed the trial. Significant changes detected included increased mean body weight (18.6‐19.5 kg, P < .02), increased body condition score (median Tufts 5‐point thin dog scale score P < .004 and WSAVA muscle condition score P < .02) and increased mean blood urea nitrogen (21.79‐30.43 mg dL−1, P < .004). On quality of life surveys, pet owners perceived their dog appeared to be panting less (P < .002) and that the general health improved (P < .03). Four dogs had a change in coat pigmentation. The peak plasma concentration of TCMCB07 in cachectic dogs was similar to that in healthy beagle dogs.Conclusions and Clinical ImportanceTCMCB07 was safe and has potential efficacy in pet dogs with cachexia.

Publisher

Wiley

Subject

General Veterinary

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