Inotrem nangibotide program gets Fast Track designation from the FDA
Category: #health  By Pankaj Singh  Date: 2019-09-03
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Inotrem nangibotide program gets Fast Track designation from the FDA
  • The company’s therapeutic solution is capable of being the first septic shock treatment which is mechanism-based.
     
  • Inotrem will start its planned multinational multicentric Phase IIb trial in patients of septic shock later in 2019.

Inotrem S.A., a biotech firm that specializes in immunotherapy for chronic and acute inflammatory syndromes, reportedly announced that the United States Food and Drug Administration (FDA) assigned Fast Track designation for its nangibotide development program that would work to treat septic shock.

Septic shock is the subsequent complication of sepsis. Septic shock incidence is continuously increasing, and its mortality is high (35%) in developed countries. No specific therapy is currently approved for this indication except symptomatic and antibiotics treatment. The company’s therapeutic solution is capable of being the first septic shock treatment which is mechanism-based.

Fast Track designation permitted by FDA is aimed to expedite and facilitate review and development of new drugs to meet an unmet medical demand in treating a serious, life threatening condition for which clinical as well as non-clinical data has showcased the potential to acknowledge and fulfil that unmet medical need.

Co-founder and CEO at Inotrem, Jean-Jacques Garaud stated that FDA’s decision to grant the company a Fast Track designation for nangibotide development program is a significant recognition of the serious requirement for causal therapies in a critical condition like septic shock as well as Inotrem’s innovative treatment approach for managing acute inflammation.

CDO of Inotrem, Margarita Salcedo Magguilli stated that the company looks forward to collaborate with FDA and advance its planned ASTONISH trial, thereby expedite its efforts to deliver the first effective treatment option for the patients of septic shock.

Inotrem will start its planned multinational multicentric Phase IIb trial in patients of septic shock later in 2019. The Phase IIb trials would focus at showcasing nangibotide’s efficacy and provide a clinically relevant proof of the clinical activity in patients with septic shock.

 

Source credit: https://www.inotrem.com/wp-content/uploads/2019/08/Fast-Track.pdf



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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