Contineum Therapeutics’ neurology hopeful, PIPE-307, has failed to make the cut during a mid-stage trial in relapsing/remitting multiple sclerosis (RRMS).
The Phase II VISTA study (NCT06083753) studying the muscarinic acetylcholine receptor 1 (M1) agonist did not meet its primary endpoint of change in binocular 2.5% low contrast letter acuity (LCLA) across treatment arms.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The small molecule drug, which is being developed in partnership with Johnson & Johnson (J&J), also missed its prespecified secondary efficacy endpoints – including various clinical and imaging endpoints.
While topline results of the VISTA study offer little hope for PIPE-307 improving vision outcomes in RRMS, Contineum will “continue to interrogate the trial data” alongside J&J to determine if the drug will exhibit any effects on exploratory endpoints.
In a 20 November statement, Contineum’s CMO and head of development, Timothy Watkins, noted that the company intends to “learn from these data” as it looks to further pursue the development of novel therapies for fibrotic and inflammatory diseases.
The California-based biopharma saw a 11% drop in its stock value, from $12.22 at market close on 20 November to $10.97 when the market opened on 21 November, after the news was announced.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataChristie Wong, managing neurology analyst at GlobalData, noted that the results of the VISTA trial are not entirely surprising, given the “modest results of the REBUILD study on clemastine”.
“The VISTA results suggest that M1 antagonism with PIPE-307 alone may be insufficient for clinically measurable remyelination or functional improvement,” Wong added.
According to Wong, currently approved MS treatments have a “limited impact on repairing neuronal damage or remyelination”. Because of this, Wong notes that there is a need for “curative products with remyelinating properties” on the market.
PIPE-307 still an MDD hopeful
Despite its setback in RRMS, Contineum is still betting on PIPE-307 in major depressive disorder (MDD). To determine the drug’s potential in this indication, J&J’s subsidiary Janssen is conducting the Phase II Moonlight-1 study (NCT06785012), which is set to read out by mid-2026.
While Myles Minter, healthcare analyst at William Blair, “sees little read-through from RRMS to MDD”, he acknowledges the study “remains risky”.
Minter noted that this estimate considers “the risky nature of placebo-controlled studies in MDD, where placebo responses have eroded effect sizes and patient heterogeneity can lead to volatility in patient response rates on active drug”.
“PIPE-307’s novel mechanism of action could give it a competitive edge in the MDD market, which is now highly competitive and genericised,” stated Wong.
Wong also noted that PIPE-307 displayed “acceptable safety and tolerability” in the VISTA trial, suggesting this trend could be further extrapolated to the MDD population.
Switching strategies
Outside of its development efforts involving PIPE-307, Contineum is hoping for success with its lead candidate, PIPE-791, in idiopathic pulmonary fibrosis (IPF).
In August 2025, it set its sights on the IPF market – holding off trials involving PIPE-791 in progressive MS (prMS) and its early-stage candidate, CTX-343, so it could advance PIPE-791 to a Phase II trial in IPF.
In a 30 October statement, Contineum noted that it is “on the cusp” of beginning the Phase II study of the lysophosphatidic acid receptor 1 (LPAR1) antagonist in IPF.
Minter supports this strategy, noting that he views the LPAR1 mechanism of action as “exciting” due to its efficacy on forced vital capacity (FVC) observed in a Phase II study with Bristol Myers Squibb’s (BMS) admilparant.
