-FDA Feedback Supports Single Pivotal Trial for Approval of Larsucosterol in Alcohol-Associated Hepatitis
- Webcast of Earnings Call Today, May 13th at 4:30 p.m. ET
CUPERTINO, Calif., May 13, 2024 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced financial results for the three months ended March 31, 2024 and provided a business update.
"We are pleased that the feedback from the U.S. Food and Drug Administration (FDA) supports the advancement of larsucosterol into a single pivotal Phase 3 clinical trial which, if successful, may serve as the basis for a New Drug Application (NDA) in alcohol-associated hepatitis (AH)," stated James E. Brown, D.V.M., President and CEO of DURECT. "We are in the process of designing the registrational Phase 3 trial incorporating the FDA's comments and insights gained from our Phase 2b AHFIRM trial. In addition, we are excited about the upcoming presentation at the European Association for the Study of the Liver (EASL) Congress 2024, which will be the first presentation of the AHFIRM data at a medical conference. We expect to provide additional details on our planned Phase 3 protocol and present new analyses from AHFIRM later in the year."
Business Update:
- During a Type C meeting with the FDA, DURECT received feedback on the recommendations for a Phase 3 clinical trial for larsucosterol in AH that could support a potential NDA filing. DURECT is in the process of designing its planned Phase 3 clinical trial based on the FDA feedback and the results from its completed Phase 2b AHFIRM clinical trial.
- DURECT announced the acceptance of a late-breaking oral presentation at the European Association for the Study of the Liver (EASL) Congress 2024 to take place June 5-8, 2024 in Milan, Italy. The presentation will feature data from the Company's Phase 2b AHFIRM trial, which evaluated the safety and efficacy of larsucosterol as a treatment for patients with severe AH.
Financial Highlights for Q1 2024:
- Total revenues were $1.8 million and net loss was $7.6 million for the three months ended March 31, 2024 compared to total revenues of $2.1 million and net loss of $12.0 million for the three months ended March 31, 2023.
- Cash, cash equivalents and investments were $21.6 million at March 31, 2024, compared to $29.8 million at December 31, 2023. Debt at March 31, 2024 was $14.6 million, compared to $16.7 million at December 31, 2023.
Earnings Conference Call
We will host a conference call and webcast today at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss the first quarter 2024 results and provide a corporate update:
Monday, May 13 @ 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time
Toll Free: | 1-877-407-0790 |
International: | 1-201-689-8560 |
Conference ID: | 13746111 |
Webcast: | https://callme.viavid.com/viavid/?callme=true&passcode=13740526&h=true&info=company-email&r=true&B=6 |
A live audio webcast of the presentation will be also available by accessing DURECT's homepage at www.durect.com on the "Events" page, under the "Investors" section. If you are unable to participate during the live webcast, the call will be archived on DURECT's website under the same section, following the completion of the call.
About the AHFIRM Trial
AHFIRM was a Phase 2b randomized, double-blind, placebo-controlled, international, multi-center study conducted in subjects with severe alcohol-associated hepatitis (AH) to evaluate the saFety and effIcacy of laRsucosterol treatMent (AHFIRM). The study was comprised of three arms and enrolled 307 patients, with approximately 100 patients in each arm: (1) Placebo, which consists of standard of care, with or without methylprednisolone capsules at the investigators' discretion; (2) larsucosterol (30 mg); and (3) larsucosterol (90 mg). Patients in the larsucosterol arms received the same supportive care without steroids. The primary outcome measure was the 90-Day incidence of mortality or liver transplantation for patients treated with larsucosterol compared to those treated with placebo, and the key secondary endpoint was 90-Day survival. The Company enrolled patients at clinical trial sites across the U.S., EU, U.K., and Australia. In November 2023, the Company announced topline data for the AHFIRM Trial. Reflecting the life-threatening nature of AH and the lack of therapeutic options, the U.S. Food and Drug Administration (FDA) has granted larsucosterol Fast Track Designation for the treatment of AH. For more information, refer to ClinicalTrials.gov Identifier: NCT04563026.
About Alcohol-associated Hepatitis (AH)
AH is an acute form of alcohol-associated liver disease (ALD) associated with long-term heavy alcohol intake, often following a recent period of increased consumption (i.e., a binge). AH is typically characterized by severe inflammation and liver cell damage, potentially leading to life-threatening complications including liver failure, acute kidney injury and multi-organ failure. There are no FDA approved therapies for AH, and a retrospective analysis of 77 studies published between 1971 and 2016, which included data from 8,184 patients, showed the overall mortality from AH was 26% at 28 days, 29% at 90 days and 44% at 180 days. A subsequent global study published in December 2021, which included 85 tertiary centers in 11 countries across 3 continents, prospectively enrolled 2,581 AH patients with a median Model of End-Stage Liver Disease (MELD) score of 23.5, reported mortality at 28 and 90 days of approximately 20% and 31%, respectively. Stopping alcohol consumption is necessary, but frequently not sufficient for recovery in many moderate (defined as MELD scores of 11-20) and severe (defined as MELD scores>20) patients, and therapies that reduce liver inflammation, such as corticosteroids, are limited by contraindications, have not been shown to improve survival at 90 days or one year, and have demonstrated an increased risk of infection. While liver transplantation is becoming more common for ALD patients, including AH patients, the total number of such transplants is still relatively small, and limited by organ availability. Average charges for a liver transplant exceed $875,000, and patients require lifelong immunosuppressive therapy to prevent organ rejection.
About Larsucosterol
Larsucosterol is an endogenous sulfated oxysterol and an epigenetic modulator. Epigenetic regulators are compounds that regulate patterns of gene expression without modifying the DNA sequence. DNA hypermethylation, an example of epigenetic dysregulation, results in transcriptomic reprogramming and cellular dysfunction, and has been reported in many acute (e.g., AH) and chronic diseases (e.g., MASH). As an inhibitor of DNA methyltransferases (DNMT1, DNMT3a and 3b), larsucosterol inhibits DNA methylation, which subsequently modulates expression of genes that are involved in cell signaling pathways associated with stress responses, cell death and survival, and lipid biosynthesis. This may ultimately lead to improved cell survival, reduced inflammation, and decreased lipotoxicity. As an epigenetic modulator, the proposed mechanism of action provides further scientific rationale for developing larsucosterol for the treatment of acute organ injury and certain chronic diseases.
About DURECT Corporation
www.durect.com and follow us on X (formerly Twitter) at https://x.com/DURECTCorp.
DURECT Forward-Looking Statements
NOTE: POSIMIR® is a trademark of Innocoll Pharmaceuticals, Ltd. in the U.S. and a trademark of DURECT Corporation outside of the U.S. SABER® is a trademark of DURECT Corporation. Other referenced trademarks belong to their respective owners. Larsucosterol is an investigational drug candidate under development and has not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities for any indication.
DURECT CORPORATION CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except per share amounts) (Unaudited) | |||||
Three months ended | |||||
March 31 | |||||
2024 | 2023 | ||||
Collaborative research and development and other revenue | $ 496 | $ 643 | |||
Product revenue, net | 1,331 | 1,411 | |||
Total revenues | 1,827 | 2,054 | |||
Operating expenses: | |||||
Cost of product revenues | 289 | 388 | |||
Research and development | 4,119 | 8,593 | |||
Selling, general and administrative | 3,136 | 4,095 | |||
Total operating expenses | 7,544 | 13,076 | |||
Loss from operations | (5,717) | (11,022) | |||
Other income (expense): | |||||
Interest and other income | 321 | 517 | |||
Interest and other expenses | (529) | (726) | |||
Change in fair value of warrant liabilities | (1,718) | 2,477 | |||
Issuance cost for warrants | - | (1,200) | |||
Loss on issuance of warrants | - | (2,033) | |||
Other income (expense), net | (1,926) | (965) | |||
Net loss | (7,643) | (11,987) | |||
Net change in unrealized gain on available-for-sale securities, net of reclassification adjustments and taxes | 4 | 6 | |||
Total comprehensive loss | $ (7,639) | $ (11,981) | |||
Net loss per share | |||||
Basic | $ (0.25) | $ (0.50) | |||
Diluted | $ (0.25) | $ (0.52) | |||
Weighted-average shares used in computing net loss per share | |||||
Basic | 30,637 | 23,767 | |||
Diluted | 30,637 | 23,940 | |||
DURECT CORPORATION CONDENSED BALANCE SHEETS (in thousands) (unaudited) | ||||
As of | As of | |||
March 31, 2024 | December 31, 2023 (1) | |||
(unaudited) | ||||
ASSETS | ||||
Current assets: | ||||
Cash and cash equivalents | $ 19,252 | $ 28,400 | ||
Short-term Investments | 2,187 | 1,280 | ||
Accounts receivable, net | 1,020 | 1,261 | ||
Inventories, net | 2,398 | 2,219 | ||
Prepaid expenses and other current assets | 1,228 | 1,511 | ||
Total current assets | 26,085 | 34,671 | ||
Property and equipment, net | 58 | 91 | ||
Operating lease right-of-use assets | 3,631 | 3,980 | ||
Goodwill | 6,169 | 6,169 | ||
Long-term restricted Investments | 150 | 150 | ||
Other long-term assets | 128 | 128 | ||
Total assets | $ 36,221 | $ 45,189 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||
Current liabilities: | ||||
Accounts payable | $ 782 | $ 1,777 | ||
Accrued liabilities | 5,105 | 5,966 | ||
Term loan, current portion, net | 14,612 | 16,663 | ||
Operating lease liabilities, current portion | 1,298 | 1,381 | ||
Warrant liabilities | 2,942 | 1,224 | ||
Total current liabilities | 24,739 | 27,011 | ||
Operating lease liabilities, noncurrent portion | 2,466 | 2,702 | ||
Other long-term liabilities | 716 | 693 | ||
Stockholders' equity | 8,300 | 14,783 | ||
Total liabilities and stockholders' equity | $ 36,221 | $ 45,189 | ||
(1) Derived from audited financial statements. | ||||
SOURCE DURECT Corporation
