Via SeekingAlpha.com

Aurinia Files Application for Voclosporin Approval

Aurinia Pharmaceuticals Inc. (AUPH) announced that it has submitting a New Drug Application for voclosporin for treating kidney inflammation. The company submitted the data obtained from a global clinical program including the pivotal Phase 3 Aurora study and the pivotal Phase 2 Aura LV study along with the application. Currently, there is no FDA-approved treatment for lupus nephritis. The drug candidate has the potential to become the first FDA-approved therapy for treating lupus nephritis.

Aurinia has also applied for Priority Review, which may help in considerably shortening the review time period to eight months from the standard time period of 12 months. The time period is considered from the time of submission. Peter Greenleaf, President and CEO of Aurinia said, “LN is a severe and debilitating consequence of lupus, which can severely impact the quality of life of individuals struggling with this disease Our extensive clinical program, including results from both the AURA and AURORA trials, provides strong support for the profile of voclosporin as a novel treatment for lupus nephritis, and we are rapidly advancing our U.S. commercial strategy and infrastructure to support a potential launch early next year.”

The AURORA clinical trial is a global, double-blind, placebo-controlled study and aimed to evaluate the efficacy of voclosporin when added to background therapy of mycophenolate mofetil. The primary endpoint for the study consisted of complete renal response at 52 weeks. Renal response was defined as UCPR of ≤ 0.5 mg/mg, eGFR ≥ 60 mL/min/1.73 m2, or no confirmed decrease from baseline in eGFR of > 20%, presence of sustained, low-dose steroids and no administration of rescue medication. The results showed Renal Response rates of 40.8% for voclosporin vs. 22.5% for the control.

The trial also met all pre-specified hierarchical secondary endpoints with statistical significance in favor of voclosporin. These endpoints included Renal Response at 24 weeks, Partial Renal Response at 24 and 52 weeks, time to achieve urinary protein-to-creatinine ratio (“UPCR”) ≤ 0.5, and time to 50% reduction in UPCR.

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The drug candidate was also found to be well-tolerated with no unexpected safety signals. 20.8 percent of voclosporin patients reported serious adverse events in comparison to 21.3 percent in the control arm. The most common SAE was infection, with 10.1 percent of voclosporin patients reporting it versus 11.2 percent of patients in the control arm.

Voclosporin, an investigational drug, has clinical data in over 2,600 patients across indications. It is an immunosuppressant which works by inhibiting calcineurin and blocking IL-2 expression and T-cell mediated immune responses. It also stabilizes the podocyte in the kidney. The drug candidate has also demonstrated more stable pharmacokinetic and pharmacodynamic relationship and potentially requires no therapeutic drug monitoring.

Contingent upon approval, Aurinia expects the patent protection to last until at least October 2027. The geographic area for such protection is expected to include the United States, Japan and Europe. The company also has a US patent covering the voclosporin dosing protocol with a term extending to December 2037. However, it is based on the FDA incorporating the dosing protocol used in both the AURA and AURORA trials into the product label.

Syndax Reports Disappointing Results for Phase 3 Trial

Syndax Pharmaceuticals Inc. (SNDX) announced that it has received the results of Phase 3 clinical trial E2112. The trial was conducted by ECOG-ACRIN Cancer Research Group and was sponsored by the National Cancer Institute. However, the study failed to meet its primary endpoint of showing a statistically significant overall survival benefit over hormone therapy alone.

The E2112 trial was a double-blind, placebo-controlled trial with 608 enrollments. It recruited patients with HR+, HER2- advanced breast cancer to receive exemestane in combination with entinostat or placebo. Briggs W. Morrison, M.D., Chief Executive Officer of Syndax, said, “We’re disappointed that the combination of entinostat and exemestane did not demonstrate a survival benefit in this historically difficult-to-treat patient population.” The company does not intend to proceed with New Drug Application filing for the medicine for metastatic breast cancer.

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The trial aimed to assess the potential of entinostat plus exemestane in patients with advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer who have progressed on a non-steroidal aromatase inhibitor. Entinostat is the company’s class I HDAC inhibitor.

Syndax elaborated that it seeks to focus on other drugs in its development pipeline. The company is also working on SNDX-5613, which is an inhibitor of the Menin-MLL interaction, and axatilimab, its anti-CSF-1R monoclonal antibody. Syndax is currently engaged in the AUGMENT-101 trial aiming to evaluate SNDX-5613 in adults suffering from relapsed/refractory acute leukemias. The company expects to present additional clinical data from the trial later this year. A recent Phase 1 data showed that control of the Menin-MLL1 interaction may trigger response in patients with genetically defined acute leukemias.

FDA Accepts Kala Pharma Refiled Application

Kala Pharmaceuticals (KALA) reported that the FDA has accepted its refiled application for Eysuvis 0.25% for treating the signs and symptoms of dry eye disease. The company had received the Complete Response Letter from the FDA in August 2019 stating the need for an additional clinical trial for demonstrating efficacy. The regulatory authority has set a Prescription Drug User Fee Act (PDUFA) goal date of October 30, 2020 for completing its review of the NDA.

Kala has submitted positive results from its STRIDE 3 for signs and symptoms of dry eye disease along with the resubmitted application. It also filed positive data from the previous clinical trials of EYSUVIS. STRIDE 3 was a Phase 3 clinical trial of the drug candidate and had met both of its primary symptom endpoints and showed a statistically significant improvement in ocular discomfort severity in both the overall intent-to-treat population and a predefined subgroup.

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The trial also met its key secondary endpoints of ocular discomfort severity at day 8 in the ITT population and conjunctival hyperemia at day 15 in the ITT population. The drug candidate also showed safety profile in line with previous clinical data. Kim Brazzell, Ph.D., Chief Medical Officer of Kala Pharmaceuticals, said, “The FDA’s acceptance of our NDA resubmission signifies critical progress toward our goal of delivering EYSUVIS as the first prescription medicine for the short-term treatment of dry eye disease. We are very appreciative that the Agency set a standard Class 2 review timeline, despite the ongoing pandemic, and we look forward to working together through their review of our NDA submission.”

Kala is a biopharmaceutical firm and uses its AMPPLIFY mucus penetrating particle Drug Delivery Technology for developing treatments for different conditions. The company already has INVELTYS 1% in the market since January 2019.

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