FDA News

FDA fast tracks microbiota therapy for children with autism

The FDA has given fast track designation to Finch Therapeutics’ Full-Spectrum Microbiota, or FSM, therapy for children with autism spectrum disorder, according to the company.

“With an estimated one in 59 children diagnosed with ASD and no FDA-approved medications indicated for the core symptoms of ASD, there is clearly a strong need to provide children and families impacted by ASD with an effective therapy,” Mark Smith, CEO of Finch Therapeutics, said in a press release. “We are very encouraged by the preliminary clinical data in this field and look forward to conducting the randomized, controlled clinical trials necessary to fully assess the safety and efficacy of FSM therapy for the treatment of children with ASD.”

A meta-analysis published in Pediatrics demonstrated that gastrointestinal symptoms, including diarrhea and abdominal pain, are more common among children with ASD compared with controls. Previous research also suggests that therapies that focus on diet, prebiotics, probiotics, antibiotics, fecal microbiota transplantation or any other treatment that alters gut microbiota may effectively treat ASD.

According to Finch Therapeutics, FSM therapy is administered through an oral capsule that contains a diverse selection of microbiota capable of restoring an unbalanced microbiome. The agency’s decision to give the therapy fast track status, which is intended to speed up the development and review of drugs to treat serious conditions and fill an unmet medical need, was based on the results of a small, open-label study of 18 children with ASD. FSM therapy reduced gastrointestinal symptoms by 77% and core ASD symptoms by 24% 8 weeks after treatment. A follow-up study of these children showed that the therapy was safe and effective 2 years after treatment.

Finch Therapeutics will conduct a phase 2 investigator-initiated clinical study examining the safety and efficacy of the FSM therapy in adults with ASD, and it will conduct a randomized, placebo-controlled, phase 2 clinical study in children. The therapy is also undergoing evaluation in a phase 2 study of patients with Clostridioides difficile.by Katherine Bortz

References:

Kang DW, et al. Sci Rep. 2019;doi:10. 1038/s41598-019-42183-0.

Li Q, et al. Front Cell Neurosci. 2017;doi:10.3389/fncel.2017.00120.

McElhannon BO, et al. Pediatrics. 2014;doi:10.1542/peds.2013-3995.

Disclosure: Smith is an employee of Finch Therapeutics.

The FDA has given fast track designation to Finch Therapeutics’ Full-Spectrum Microbiota, or FSM, therapy for children with autism spectrum disorder, according to the company.

“With an estimated one in 59 children diagnosed with ASD and no FDA-approved medications indicated for the core symptoms of ASD, there is clearly a strong need to provide children and families impacted by ASD with an effective therapy,” Mark Smith, CEO of Finch Therapeutics, said in a press release. “We are very encouraged by the preliminary clinical data in this field and look forward to conducting the randomized, controlled clinical trials necessary to fully assess the safety and efficacy of FSM therapy for the treatment of children with ASD.”

A meta-analysis published in Pediatrics demonstrated that gastrointestinal symptoms, including diarrhea and abdominal pain, are more common among children with ASD compared with controls. Previous research also suggests that therapies that focus on diet, prebiotics, probiotics, antibiotics, fecal microbiota transplantation or any other treatment that alters gut microbiota may effectively treat ASD.

According to Finch Therapeutics, FSM therapy is administered through an oral capsule that contains a diverse selection of microbiota capable of restoring an unbalanced microbiome. The agency’s decision to give the therapy fast track status, which is intended to speed up the development and review of drugs to treat serious conditions and fill an unmet medical need, was based on the results of a small, open-label study of 18 children with ASD. FSM therapy reduced gastrointestinal symptoms by 77% and core ASD symptoms by 24% 8 weeks after treatment. A follow-up study of these children showed that the therapy was safe and effective 2 years after treatment.

Finch Therapeutics will conduct a phase 2 investigator-initiated clinical study examining the safety and efficacy of the FSM therapy in adults with ASD, and it will conduct a randomized, placebo-controlled, phase 2 clinical study in children. The therapy is also undergoing evaluation in a phase 2 study of patients with Clostridioides difficile.by Katherine Bortz

References:

Kang DW, et al. Sci Rep. 2019;doi:10. 1038/s41598-019-42183-0.

Li Q, et al. Front Cell Neurosci. 2017;doi:10.3389/fncel.2017.00120.

McElhannon BO, et al. Pediatrics. 2014;doi:10.1542/peds.2013-3995.

Disclosure: Smith is an employee of Finch Therapeutics.