CUPERTINO, CA, USA I January 2, 2020 I DURECT Corporation (Nasdaq: DRRX) today announced the results from its Phase 2a clinical trial of DUR-928 in patients with mild to moderate plaque psoriasis. Twenty-two patients completed the study, applying DUR-928 topically to the plaque on one arm and the vehicle (placebo) to a similar plaque on the other arm daily for 28 days.
DUR-928 did not demonstrate a benefit over vehicle (placebo) based on Investigator’s Global Assessment (IGA), which was the scoring system for the primary analysis, or in any of the secondary analyses. Daily topical application of DUR-928 was well tolerated with no meaningful differences in adverse events between the treatment and vehicle (placebo) groups. There were no AEs attributed to the study drug.
“Based on the top-line data, we do not plan to continue development of topical DUR-928 in psoriasis,” said James E. Brown, President and CEO of DURECT. “With the recently announced positive results from our Phase 2a alcoholic hepatitis trial, our focus moving forward with DUR-928, will be on completing the NASH trial in the first half of this year and initiating the Phase 2b AH trial in the middle of the year.”
About the DUR-928 Psoriasis Phase 2a Trial
The trial was a Phase 2a, randomized, double-blind, vehicle-controlled, multi-center, proof-of-concept study in which DUR-928 was applied topically once-daily for 28 days with a 28-day follow-up period in patients with mild to moderate plaque psoriasis. The trial was conducted in the U.S. Each patient served as their own control, applying DUR-928 to the plaque on one arm and the vehicle (placebo) to a similar plaque on the other arm. After the treatment period, patients were followed for an additional four weeks.
About DURECT Corporation
DURECT is a biopharmaceutical company actively developing therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms. DUR‑928, a new chemical entity in Phase 2 development, is the lead candidate in DURECT’s Epigenetic Regulator Program. An endogenous, orally bioavailable small molecule, DUR-928 has been shown in preclinical studies to play an important regulatory role in lipid homeostasis, inflammation, and cell survival. Human applications may include acute organ injury such as AH and acute kidney injury (AKI) and chronic hepatic diseases such as NASH. DURECT’s advanced oral and injectable delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs. Key product candidates in this category include POSIMIR® (bupivacaine extended-release solution), an investigational locally-acting, non-opioid analgesic intended to provide up to 3 days of continuous pain relief after surgery, and a long-acting injectable SABER-based HIV investigational product being developed with Gilead. For more information about DURECT, please visit www.durect.com.
SOURCE: CURECT Corp
Post Views: 138
CUPERTINO, CA, USA I January 2, 2020 I DURECT Corporation (Nasdaq: DRRX) today announced the results from its Phase 2a clinical trial of DUR-928 in patients with mild to moderate plaque psoriasis. Twenty-two patients completed the study, applying DUR-928 topically to the plaque on one arm and the vehicle (placebo) to a similar plaque on the other arm daily for 28 days.
DUR-928 did not demonstrate a benefit over vehicle (placebo) based on Investigator’s Global Assessment (IGA), which was the scoring system for the primary analysis, or in any of the secondary analyses. Daily topical application of DUR-928 was well tolerated with no meaningful differences in adverse events between the treatment and vehicle (placebo) groups. There were no AEs attributed to the study drug.
“Based on the top-line data, we do not plan to continue development of topical DUR-928 in psoriasis,” said James E. Brown, President and CEO of DURECT. “With the recently announced positive results from our Phase 2a alcoholic hepatitis trial, our focus moving forward with DUR-928, will be on completing the NASH trial in the first half of this year and initiating the Phase 2b AH trial in the middle of the year.”
About the DUR-928 Psoriasis Phase 2a Trial
The trial was a Phase 2a, randomized, double-blind, vehicle-controlled, multi-center, proof-of-concept study in which DUR-928 was applied topically once-daily for 28 days with a 28-day follow-up period in patients with mild to moderate plaque psoriasis. The trial was conducted in the U.S. Each patient served as their own control, applying DUR-928 to the plaque on one arm and the vehicle (placebo) to a similar plaque on the other arm. After the treatment period, patients were followed for an additional four weeks.
About DURECT Corporation
DURECT is a biopharmaceutical company actively developing therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms. DUR‑928, a new chemical entity in Phase 2 development, is the lead candidate in DURECT’s Epigenetic Regulator Program. An endogenous, orally bioavailable small molecule, DUR-928 has been shown in preclinical studies to play an important regulatory role in lipid homeostasis, inflammation, and cell survival. Human applications may include acute organ injury such as AH and acute kidney injury (AKI) and chronic hepatic diseases such as NASH. DURECT’s advanced oral and injectable delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs. Key product candidates in this category include POSIMIR® (bupivacaine extended-release solution), an investigational locally-acting, non-opioid analgesic intended to provide up to 3 days of continuous pain relief after surgery, and a long-acting injectable SABER-based HIV investigational product being developed with Gilead. For more information about DURECT, please visit www.durect.com.
SOURCE: CURECT Corp
Post Views: 138
