Apitegromab (SRK-015) is a fully human monoclonal antibody developed to treat spinal muscular atrophy. It works by binding to and inhibiting inactive myostatin and promyostatin, which is a precursor to myostatin. Myostatin limits the size of skeletal muscle tissue. It does not bind to active myostatin, activin A, active BMP9/10 or TGFβ1 that all operate on activin type 2 receptors.[1][2][3]
Trials
In the EMBRAZE Phase 2 weight loss trial (102 people, 24 weeks) Tirzepatide + apitegromab reduced muscle lose by 55% compared to tirzepatide + placebo.[4]
References
- ^ Barrett D, Bilic S, Chyung Y, Cote SM, Iarrobino R, Kacena K, et al. (2021). “A Randomized Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Study of the Novel Myostatin Inhibitor Apitegromab (SRK-015): A Potential Treatment for Spinal Muscular Atrophy”. Advances in Therapy. 38 (6): 3203–3222. doi:10.1007/s12325-021-01757-z. ISSN 0741-238X. PMC 8189951. PMID 33963971.
- ^ Crawford T, Darras B, Day J, Song G, Nomikos G, Place A, et al. (3 May 2022). “Apitegromab in Spinal Muscular Atrophy (SMA): An Analysis of Multiple Efficacy Endpoints in the TOPAZ Trial (P15-5.005)”. Neurology. 98 (18 Supplement) 1859. doi:10.1212/WNL.98.18_supplement.1859. ISSN 0028-3878.
- ^ Crawford T, Place A, Barrett D, Cote S, Nomikos G, Song G, et al. (2021). “Relationship of pharmacokinetics and pharmacodynamics to apitegromab efficacy in patients with later-onset spinal muscular atrophy (Types 2 and 3 SMA): Results from the TOPAZ study”. Journal of the Neurological Sciences. 429 118388. doi:10.1016/j.jns.2021.118388. S2CID 238481481.
- ^ Wilding JP, Batterham RL, Calanna S, Van Gaal LF, McGowan BM, Rosenstock J, et al. (3 May 2021). “Impact of Semaglutide on Body Composition in Adults With Overweight or Obesity: Exploratory Analysis of the STEP 1 Study”. Journal of the Endocrine Society. 5 (Supplement_1): A16–A17. doi:10.1210/jendso/bvab048.030. ISSN 2472-1972. PMC 8089287.
