Bimagrumab

Bimagrumab
Monoclonal antibody
Type	?
Source	Human
Target	ACVR2B
Clinical data
Other names	BYM338
ATC code	none;
Identifiers
CAS Number	1356922-05-8;
ChemSpider	none;
UNII	N15SW1DIV8;
KEGG	D10620 ;
Chemical and physical data
Formula	C6306H9732N1684O1990S46
Molar mass	142451.78 g·mol−1

Bimagrumab (BYM338) is a human monoclonal antibody developed by Novartis to treat pathological muscle loss and weakness. It binds to and inhibits activin receptor type-2B.[1]

On August 20, 2013, it was announced that bimagrumab had received a breakthrough therapy designation for sporadic inclusion body myositis (sIBM) by the US Food and Drug Administration.[2]

In 2014, Bimagrumab entered Phase II development, with some research indicating clinical effects.[3] Novartis planned to apply in 2016 for FDA approval to treat sIBM patients with bimagrumab.[4]

In April 2016, Novartis announced that bimagrumab had failed a Phase IIb/III study for sporadic inclusion body myositis.[5]

In January 2021, a new study confirmed that treatment with Bimagrumab is safe and effective for treating excess adiposity and metabolic disturbances of adult patients with obesity and type 2 diabetes.[6]

In January 2023 the medication entered phase IIb trials for obesity.[7]

Bimagrumab must be administered intravenously at a hospital or clinic. The medication has a long half life and is administered once a month.[7]

References

Garito, Tania; Zakaria, Marjorie; Papanicolaou, Dimitris A.; Li, Yifang; Pinot, Pascale; Petricoul, Olivier; Laurent, Didier; Rooks, Daniel; Rondon, Juan Carlos; Roubenoff, Ronenn (June 2018). "Effects of bimagrumab, an activin receptor type II inhibitor, on pituitary neurohormonal axes". Clinical Endocrinology. 88 (6): 908–919. doi:10.1111/cen.13601. ISSN 1365-2265. PMID 29566437.
"Novartis receives FDA breakthrough therapy designation for BYM338 (bimagrumab) for sporadic inclusion body myositis (sIBM)". Retrieved 20 August 2013.
Amato AA, Sivakumar K, Goyal N, David WS, Salajegheh M, Praestgaard J, et al. (December 2014). "Treatment of sporadic inclusion body myositis with bimagrumab". Neurology. 83 (24): 2239–46. doi:10.1212/WNL.0000000000001070. PMC 4277670. PMID 25381300.
Novartis: Planned filings 2015 to >=2019. Retrieved 27 May 2015.
Novartis’ ‘breakthrough’ muscle drug bimagrumab flunks a late-stage trial
"Medication shows promise for weight loss in patients with obesity, diabetes". EurekAlert!. Retrieved 2021-01-20.
Healthcare, GlobalData (2023-01-17). "Versanis' bimagrumab, first-in-class obesity therapy, enters Phase IIb of development". Pharmaceutical Technology. Retrieved 2023-05-27.

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[1] Garito, Tania; Zakaria, Marjorie; Papanicolaou, Dimitris A.; Li, Yifang; Pinot, Pascale; Petricoul, Olivier; Laurent, Didier; Rooks, Daniel; Rondon, Juan Carlos; Roubenoff, Ronenn (June 2018). "Effects of bimagrumab, an activin receptor type II inhibitor, on pituitary neurohormonal axes". Clinical Endocrinology. 88 (6): 908–919. doi:10.1111/cen.13601. ISSN 1365-2265. PMID 29566437.

[2] "Novartis receives FDA breakthrough therapy designation for BYM338 (bimagrumab) for sporadic inclusion body myositis (sIBM)". Retrieved 20 August 2013.

[3] Amato AA, Sivakumar K, Goyal N, David WS, Salajegheh M, Praestgaard J, et al. (December 2014). "Treatment of sporadic inclusion body myositis with bimagrumab". Neurology. 83 (24): 2239–46. doi:10.1212/WNL.0000000000001070. PMC 4277670. PMID 25381300.

[4] Novartis: Planned filings 2015 to >=2019. Retrieved 27 May 2015.

[5] Novartis’ ‘breakthrough’ muscle drug bimagrumab flunks a late-stage trial

[6] "Medication shows promise for weight loss in patients with obesity, diabetes". EurekAlert!. Retrieved 2021-01-20.

[:0-7] Healthcare, GlobalData (2023-01-17). "Versanis' bimagrumab, first-in-class obesity therapy, enters Phase IIb of development". Pharmaceutical Technology. Retrieved 2023-05-27.