Star companies have fallen, microbial pharmaceutical in the end has no future?

New microbial drugs have completed the closed loop of commercialization

Of course, regardless of the dilemma of clinical development, the market demand for microbiological drugs is clear.

In April 2023, Seres Therapeutics' SER-109 was approved for marketing under the trade name VOWST for the treatment of recurrent Clostridium difficile infections. The commercialisation of VOWST, the world's first oral microbiome containing a beneficial gut bacterium known as Firmicutes, will be jointly carried out by Seres and Nestle, who will split the sales revenue equally.

As a new clinical drug, VOWST has achieved remarkable market feedback since its launch. According to the latest financial report released by Seres, after the approval of VOWST, it began to be marketed in the United States in June 2023, and by the end of September, 610 completed prescription registration forms had been received. Of these, 282 patients have started treatment with VOWST. In addition, VOWST is not currently covered by commercial insurance, and these prescription registration forms are submitted by more than 480 different health care providers, 78 of whom have prescribed VOWST to more than one patient.

It is worth noting that VOWST is not priced low, and there are other options besides VOWST for clinical use in the treatment of C. difficile. Clostridium difficile is a bacterium commonly found in a healthy gut microbiome. When someone takes antibiotics, it can change the balance of gut microbes and lead to a life-threatening Clostridium difficile infection (CDI). Even if they are cleared, the infection may recurs several times due to an imbalance in the gut flora.

At present, the most common clinical treatment option for C. difficile infection is fecal transplantation, but this treatment has been very poor experience, and people have been trying to develop new treatment options. In addition to VOWST, biologic agent Betuximab and enema REBYOTA are all new therapies that have appeared in recent years. Among them, REBYOTA will be launched in 2022, is the world's second approved microbial drug, it also needs to collect intestinal microbial samples from healthy donors, and traditional fecal microbial transplantation is different in the preparation of REBYOTA involves a strict charge process to ensure the stability of microbial treatment.

At this stage, there is no research data that directly compares VOWST to the above alternatives due to the short time on the market. However, from the cross-comparison of data, the effectiveness of VOWST is higher than that of REBYOTA and betuximab, and under fecal bacteria transplantation, the treatment cost is the highest among the four types of programs, but the drug route is the most friendly. The relatively good curative effect and convenient oral dosage form may be the reason for the popularity of VOWST.

In the earnings report, Seres also acknowledged that VOWST is a great product, but the commercialization prospects are uncertain due to the very high price. From a cost-control perspective, commercial insurance plans may only use VOWST as a second-line option, that is, after a cheaper alternative fails. Regardless of price, VOWST is easily the first line option for doctors and patients to prevent recurrent Clostridium difficile infections. Of course, Seres is also trying to reduce the cost of commercial use of VOWST. In August 2023, Seres closed one of its three donor collection centers and set up a donor screening lab to reduce costs.

In a sense, over the past 10 years, hundreds of clinical trials have rapidly verified the clinical value of microbial pharmaceuticals. For now, microbiotics are stuck on commercial value. When nearly half of the overseas microbial pharmaceutical star companies have collapsed, people can not help but pinch sweat for this industry. But the more granular observation is that the industry still has the opportunity to squat and jump. We still hope to see more new microbial drugs to address complex clinical challenges when the trial-and-error space and funding environment become appropriately loose.