On November 2, 2021 DURECT Corporation (Nasdaq: DRRX) reported financial results for the three months ended September 30, 2021 and provided a corporate update (Press release, DURECT, NOV 2, 2021, View Source [SID1234594108]).
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"I am proud of the progress we have made in expanding clinical trial sites and the pace of enrollment in the AHFIRM study, particularly given the challenges faced by many of the hospitals where our study is being conducted in dealing with the Delta variant surge." stated James E. Brown, DVM, President and CEO of DURECT. "I am also pleased with the progress made in our POSIMIR licensing process."
Third Quarter and Recent Business Highlights:
Continued progress in clinical study site openings – DURECT has increased the total number of planned sites for the Phase 2b AHFIRM study to 60+. Since the last earnings call, the Company has opened an additional 10 clinical trial sites. There are now 36 global AHFIRM study sites open, more than 50% of the planned locations.
Opening of first ex-US sites – DURECT also recently opened the first ex-US study sites in Australia. This marks the beginning of the ex-US expansion of the AHFIRM study.
USAN Council name approved – The United States Adopted Names (USAN) Council has approved ‘larsucosterol’ as the nonproprietary (generic) name for DUR-928.
Progress with POSIMIR partnering – POSIMIR licensing negotiations continue to advance.
Upcoming Key Milestones:
DURECT is focused on advancing DUR-928 (larsucosterol) for the treatment of AH
At the AASLD Liver Meeting November 12-15, Suthat Liangpunsakul, M.D. will present a poster reporting the growing prevalence of AH hospitalizations in the U.S., highlighting the growing unmet need for these patients.
With strong interest from hepatologists to join the study, we plan to continue to expand the AHFIRM study to more than 60 total clinical trial sites across the U.S., E.U., U.K., and Australia.
We expect to initiate ex-US dosing in the AHFIRM study in the coming weeks.
We are on track to complete a POSIMIR license deal with a U.S. partner who would subsequently launch the product.
We will determine next steps for larsucosterol in non-alcoholic steatohepatitis (NASH).
Financial highlights for Q3 2021:
Total revenues were $2.2 million and net loss was $10.0 million for the three months ended September 30, 2021, compared to total revenues of $1.8 million and net loss of $9.3 million for the three months ended September 30, 2020.
At September 30, 2021, cash and investments were $80.9 million, compared to cash, cash held in escrow and investments of $56.9 million at December 31, 2020. Debt at September 30, 2021 was $20.5 million, compared to $20.8 million at December 31, 2020
Conference Call:
We will host a conference call today at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss third quarter 2021 results and provide a corporate update:
The conference call will also be available by webcast on DURECT’s homepage at www.durect.com under the "Investors" tab. If you are unable to participate during the webcast, the call will be archived on DURECT’s website under "Event Calendar" in the "Investors" section.
About the AHFIRM Trial
Enrollment is ongoing in our Phase 2b study in subjects with severe acute AH to evaluate saFety and effIcacy of DUR-928 treatMent (AHFIRM). AHFIRM is a randomized, double-blind, placebo-controlled, international, multi-center Phase 2b study to evaluate the safety and efficacy of larsucosterol (also known as DUR-928) in approximately 300 patients with severe AH. The study is comprised of three arms targeting enrollment of approximately 100 patients each: (1) Placebo plus standard of care (SOC, which may include the use of methylprednisolone, a corticosteroid, at the discretion of the treating physician); (2) larsucosterol (30 mg); and (3) larsucosterol (90 mg). All patients in the trial receive supportive care. The primary outcome measure is 90-day survival rate for patients treated with larsucosterol compared to those treated with placebo plus SOC. The Company is targeting more than 60 clinical trial sites across the U.S., E.U., U.K., and Australia. Reflecting the life-threatening nature of AH and the lack of therapeutic options for this devastating condition, the FDA has granted larsucosterol Fast Track Designation for the treatment of AH. We believe demonstration of a robust survival benefit in the AHFIRM trial would support an NDA filing.