Delving into the Latest Updates on Anti-rabies monoclonal antibody(MassBiologics) with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-rabies monoclonal antibody, RMab, Rabies human monoclonal antibody

+ [3]

Target

RABV-G

Mechanism

RABV-G inhibitors(RABV-G inhibitors)

Therapeutic Areas

Infectious DiseasesOther Diseases

Active Indication

Rabies

Inactive Indication

Immune System DiseasesInflammationNeoplasms

Originator Organization

MassBiologics

Active Organization

Serum Institute of India Pvt Ltd.MassBiologics

Inactive Organization

PharmaPraxis

Drug Highest PhaseApproved

First Approval Date

IN (01 Jan 2016),

Rabies

Regulation-

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Gene Sequence

Sequence Code 11821L

Sequence Code 11816H

INTRODUCTIONDenosumab (Dmab) is widely used for the treatment of post-menopausal osteoporosis. Its discontinuation is sometimes accompanied by multiple vertebral fractures. Romosozumab (Rmab) has not been tested for its ability to prevent the rebound phenomenon.CASE PRESENTATIONWe present the case of a 68-year-old female patient with post-menopausal osteoporosis under treatment with Rmab who presented with multiple vertebral fractures after denosumab discontinuation. The addition of Rmab did not prevent new-onset rebound-associated vertebral fractures. The patient discontinued Rmab and Dmab was re-initiated. After six months, no new vertebral fractures occurred, bone mineral density increased and bone turnover markers remained suppressed.DISCUSSIONOur clinical case illustrates the ineffectiveness of Rmab to prevent the multiple vertebral fracture cascade attributable to discontinuation of Dmab. We believe that treatment with Rmab might not be enough to prevent this phenomenon. Treatment with Dmab or possibly combination treatment with Dmab and Rmab could be another treatment option.

11 Mar 2024·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

Defining the volume of rabies immunoglobulins/ rabies monoclonal antibodies requirement for wound infiltration of category III animal exposures – an exploratory study

Q3 · MEDICINE

Article

Author: Prashanth, Ramya M. ; Surendran, Jithin ; Sudarshan, Mysore K. ; Narayana, D. H. Ashwath ; Haradanhalli, Ravish S. ; Kumari, Nitu

WHO recommends infiltration of rabies immunoglobulins/rabies monoclonal antibodies as anatomically possible, into or close to all category III animal bite wound(s)/exposures for post exposure prophylaxis. The volume required for wound infiltration depending upon the site/size/severity of wound is yet to be defined for guiding the treating physicians. This study aimed to determine the volume of rabies immunoglobulin/rabies monoclonal antibody required for wound infiltration depending upon the site, size, and severity. A prospective cohort study was conducted including category III animal exposures at the anti-rabies clinic, KIMS hospital and Research Center, Bangalore, India. The volume of rabies immunoglobulins/rabies monoclonal antibodies required for wound infiltration, depending on site, severity, and size was determined. All the subjects were followed for 6 months to demonstrate the safety and clinical efficacy of post exposure prophylaxis. The present study included 717 subjects having 1428 bite wounds. There was a significant difference in the median volume required for wound infiltration based on site, size, and severity of bite wounds. However, on pairwise comparison; the median volume among all the pairs for only wound size was found to be statistically significant. Supportively, a strong positive correlation was seen with the size of wound and volume infiltrated. The volume of rabies immunoglobulin/rabies monoclonal antibodies required for wound infiltration shall be determined according to size of wounds, i.e. 1 ml for <1 cm wound, 3 ml for 1-5 cm wound, and 5 ml for >5 cm wound.

12 Jan 2024·Cureus

Real-World Safety of TwinRab, the World’s First Novel Cocktail of Rabies Monoclonal Antibodies, in a Clinical Setting

Article

Author: Manna, Asis ; Mahajan, Manish ; Sharma Sarkar, Biswanath ; Dutta, Trayambak ; Kundu, Asis Kumar ; Maji, Baisakhi

OBJECTIVESEvery year, 18,000-20,000 people die from rabies in India, with children younger than the age of 15 accounting for 30%-60% of all cases. Wound cleaning, vaccination, and rabies immunoglobulin (RIG) administration are all part of treatment. TwinRab^TM, a unique combination of two monoclonal antibodies (mAbs), docaravimab and miromavimab, effectively neutralizes rabies and rabies-like viruses. We conducted this study to evaluate the safety of the cocktail in patients infected with category-III animal bites according to WHO guidelines.METHODSThis open-label observational study was conducted in patients with WHO category-III animal bites by suspected rabid animals. All participants were screened, enrolled, and were administered the TwinRab^TM manufactured by Zydus Lifesciences Ltd. at the rate of 40 IU/kg by infiltration in and around the wound along with anti-rabies vaccine (ARVs). Participants were assessed at various intervals, and any adverse events (AEs) were documented and reported to the sponsor within 24 hours.RESULTThe study enrolled 401 participants, 55.61% (n = 223) male, whose median age was 34 years. Adults made up 69.83% (n = 280) of the participants. The most exposed sites were the lower parts of the body (60.6%, n = 243); 99.75% (n = 400) of the population showed normal cardiovascular, gastrointestinal, and central nervous systems. After seven days of the last postexposure prophylaxis (PEP) dose, 9.98% of the total study population experienced 80 mild local solicited AEs and were assessed and treated.CONCLUSIONThe study concluded that TwinRab^TM when given in a 40 IU/kg dose with Essen or the updated Thai Red Cross Vaccine regimen, provides safe and effective rabies prophylaxis in WHO category III patients exposed to suspected rabied animal bites.

100 Deals associated with Anti-rabies monoclonal antibody(MassBiologics)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J06BB05	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Rabies	IN	-	01 Jan 2016

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Immune System Diseases	Preclinical	BR	PharmaPraxis	23 Apr 2012
Inflammation	Preclinical	BR	PharmaPraxis	23 Apr 2012
Neoplasms	Preclinical	BR	PharmaPraxis	23 Apr 2012

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CTRI/2012/05/002709 (Pubmed \| Clin Infect Dis)	Phase 2/3	-	200	SII RMAb	hbtynameon(pqybgopvax) = whbqdjmouj hgeflhbjhe (iqhetrqkhq, 18.94 - 32.74)	Positive	18 Jan 2018
				HRIG	hbtynameon(pqybgopvax) = ucptklqaep hgeflhbjhe (iqhetrqkhq, 4.11 - 8.41)
EULAR2003	Phase 2	Rheumatoid Arthritis CD19 \| CD3 \| IgG ... View more	161	MTX	byxeygsnfn(zombsygkeo) = rxogmdxibi jkptvkmvwg (ezssmtyjuy ) View more	Positive	18 Jun 2003
				Rmab	byxeygsnfn(zombsygkeo) = glappuitoq jkptvkmvwg (ezssmtyjuy ) View more