Plans to start a new Phase II study of SER-109, branded ECOSPOR III, have been announced by Seres Therapeutics Inc (NASDAQ:MCRB). The drug is meant to treat patients who are suffering from an infection known as clostridium difficile. This came about following a meeting with the Food and Drug Administration.
“Following the completion of our comprehensive analyses of the SER-109 study results, we had very productive discussions with the FDA, in which we gained highly positive and constructive guidance on further SER-109 clinical development,” Seres Therapeutics chairman and chief executive officer, Roger Pomerantz, said.
Pioneering a microbiome therapeutic
If the drug gets the approval of the FDA, it will become the pioneering microbiome therapeutic in the market. The gastrointestinal drug serves as fecal transplant alternative and has sometimes been referred to as a ‘poop pill’ though Seres Therapeutics has refused to encourage such a nickname. Perhaps, though, it would be fitting and encourage sales.
The greenlight from the FDA to have the study carried out follows the case of the earlier trial having gone wrong. This happened after certain participants were misdiagnosed as they were not suffering from clostridium difficile. Another problem that was witnessed was that some of the participants were not given an adequate SER-109 dose.
More accuracy, more participants
Some of the changes that Seres Therapeutics will be making in the new trial include measuring the infection using a mechanism that is more accurate. Patients will also be given a bigger dose, at least 10 times higher. The number of participants in the trial will also increase from 89 to 320 patients.
The U.S. Food and Drug Administration has also come to an agreement to designate the trial a pivotal study in the event that the gastrointestinal drug proves to be effective and is able to meet the other regulatory conditions.
Currently, two designations have been given to SER-109 by the FDA and these could put the drug on the path of being quickly approved. These include being designated as a therapy that offers a potential breakthrough and orphan drug status.
On Thursday shares of Seres Therapeutics Inc jumped by 37.11% to close the day at $12.71.