CAMBRIDGE -
VOWST, the first FDA approved orally administered microbiome therapeutic, received FDA approval in April of 2023 and is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI). VOWST is being commercialized by
'In 2023, VOWST received FDA approval with a broad indication, which includes use in first recurrence patients. We are thrilled, along with our collaborators at
'Seres is looking forward to 2024 as we continue to build on our initial VOWST commercial success. The SER-155 Cohort-2 readout is expected in the third quarter, and we are excited to announce receipt of Fast Track Designation for SER-155 to reduce the risk of infection and GvHD in allo-HSCT patients. Fast Track Designation is awarded to expedite both drug development and FDA review of drugs to treat serious conditions and fulfill an unmet medical need.'
'I'm pleased with the significant progress made on our launch priorities since the commercial availability of VOWST in June,' said
Seres will present at the 42nd annual
VOWST Commercial Performance
Broad demand for VOWST has been observed across rCDI patients and healthcare providers since product launch in
Fourth quarter net sales were approximately
Fourth quarter completed prescription enrollment forms received for VOWST were 1,322; of those 1,082 resulted in new patient starts by year-end 2023.
Total 2023 completed prescription enrollment forms received for VOWST since launch were 2,833; of those 2,015 resulted in new patient starts by year-end 2023.
In 2023, prescription enrollment forms were submitted by approximately 1,330 unique healthcare providers (HCPs) since launch; approximately 340 HCPs have prescribed VOWST to more than one patient.
Seres 2023 Highlights
VOWST received FDA approval in April as the first and only FDA approved orally administered microbiome therapeutic to prevent recurrence of CDI in patients with rCDI, after treatment with standard of care antibacterials.
Strong adoption of VOWST since commercial launch in
Production of VOWST commercial supply enabled a strong commercial launch within weeks of approval; progress in expansion of VOWST manufacturing capacity.
SER-155 Phase 1b Cohort 1 clinical data showed favorable tolerability, successful drug bacteria engraftment, and a substantial reduction in pathogen domination in the gastrointestinal microbiome supporting progression to the placebo-controlled Cohort 2.
SER-155 received US FDA Fast Track Designation.
Completed strategic restructuring of Company to focus resources and investment on continued VOWST growth, completion of SER-155 Phase 1b study and supporting longer-term business sustainability.
Named to 'TIME 100 Most Influential Companies' list of 100 companies making an extraordinary impact around the world.
Anticipated 2024 Milestones
Expect continued progress in 2024 towards commercial priorities including: Expansion of the number of HCPs prescribing VOWST as a result of new efforts scaled in Q4 2023 such as strengthened promotional campaigns and expanded reach of HCP and patient digital promotion.
Growth of VOWST utilization earlier in the treatment paradigm including in patients experiencing their first recurrence.
Maintenance of strong patient access and expansion of payer coverage for VOWST across Commercial and Medicare Part D plans.
Increasing penetration of the hospital outflow patient segment.
SER-155 Phase 1b placebo-controlled Cohort 2 data readout anticipated in third quarter of 2024.
Seres ended 2023 with preliminary cash, cash equivalents and investments of approximately
About
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including the commercial success and continued growth of VOWST, the timing and results of our clinical studies, access to additional debt tranches, the sufficiency of cash to fund operations, and other statements which are not historical fact.
These forward-looking statements are based on management's current expectations. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Contact:
Email: Rwindsor@serestherapeutics.com
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