Upstream Bio plans to begin Phase 3 trials of verekitug in severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) in the first quarter of 2027. The clinical-stage biotech is positioning the drug around a potential combination of strong efficacy and quarterly dosing, while continuing a Phase 2 study in chronic obstructive pulmonary disease (COPD).
The company ended the third quarter with $207.4 million in cash, cash equivalents and short-term investments, which it expects to cover planned operations through 2027.
Key details
- Phase 3 preparations: Upstream says clinical, regulatory and manufacturing milestones are in place for the planned Phase 3 starts in severe asthma and CRSwNP. It is prioritizing those two indications for its next stage of development.
- Clinical evidence so far: More than 500 participants have received verekitug across the company’s clinical programs. Upstream reports positive Phase 2 results in severe asthma and CRSwNP.
- COPD study: The Phase 2 VENTURE trial has enrolled about 480 adults with moderate-to-severe COPD. It is testing dosing intervals of 12 and 24 weeks, with annualized COPD exacerbation rates as its primary measure. Results are expected in the second half of 2027.
- Long-term asthma study: More than 90% of eligible participants from the Phase 2 VALIANT severe asthma trial have continued into the VALOUR extension study, which is assessing longer-term efficacy and safety. Results are also expected in the second half of 2027.
- Drug approach: Verekitug targets the receptor for TSLP, an immune-signaling molecule involved in inflammation. Upstream describes it as the only antagonist in clinical development that targets this receptor and is seeking to develop it for quarterly dosing, potentially at home.
- Quarterly expenses and loss: Research and development spending was $36.6 million, up from $33.0 million a year earlier, mainly because of higher personnel and clinical-program costs. General and administrative expenses rose to $7.2 million from $5.5 million, reflecting higher personnel costs and professional fees. Net loss widened to $41.2 million from $33.7 million.
What changes for investors
The planned Phase 3 launches would move verekitug into late-stage testing in two indications where Upstream says it has already seen positive Phase 2 results. The company’s stated cash runway extends through 2027, the same year it expects results from its ongoing COPD and long-term asthma studies.