PharmaShots Interview: Aurinia's Neil Solomons Shares Insights on the Lupkynis

In an interview with PharmaShots, Neil Solomons, Co-founder and Chief Medical Officer of Aurinia shared his views on the data of Lupkynis (voclosporin) presented at the National Kidney Foundation 2021 Spring Clinical Meetings.

Shots:

New data analysis from the AURORA and AURA clinical studies shows that Aurinia's therapy demonstrated efficacy across all LN biopsy classes. These data show that treatment with Aurinia's therapy can help people achieve kidney health regardless of their disease stage
The recommended starting dose of Lupkynis is three capsules twice daily with no requirement for serum drug monitoring. Dose modifications can be made based on Aurinia's proprietary personalized eGFR based dosing protocol
Lupkynis is the first FDA-approved oral treatment for the treatment of adult patients with active LN

Tuba: Discuss the key points of the data presented at NKF2021.

Neil: Pooled data from the AURA-LV and AURORA 1 study demonstrate that LUPKYNIS, in combination with mycophenolate mofetil (MMF) and low-dose corticosteroids, led to treatment benefits across biopsy class subgroups compared with treatment with MMF and low-dose corticosteroids alone (placebo). MMF and low-dose corticosteroids are considered standard of care (SoC) for the treatment of LN.

Tuba: What is the impact of the data on the potential treatment of LN?

Neil: The new data analysis from the AURORA and AURA clinical studies show that LUPKYNIS demonstrated efficacy across all LN biopsy classes, which is important because people with LN often experience delays in diagnosis, which may cause them to progress in disease severity. This data shows that treatment with Aurinia's therapy can help people achieve reductions in proteinuria (protein in the urine) regardless of disease stage.

Tuba: Tell us more about Lupus Nephritis. Discuss the symptoms, treatments, and complications related to the disease.

Neil: Lupus nephritis (LN) is an inflammation of the kidneys that represents one of the most serious complications of the chronic autoimmune disease systemic lupus erythematosus (SLE). In LN, inflammation leads to tissue damage and protein in the urine (proteinuria). If left untreated, LN can lead to irreversible kidney damage, kidney failure, or even death. Approximately 45% of people with SLE develop LN at some point in their lifetime, and approximately a third have LN when they are diagnosed with SLE. There are approximately 500,000 people with SLE in the United States, making people with LN a significant subset of the total SLE population.

In patients with lupus nephritis, kidney damage may start prior to the first clinically detected episode of lupus nephritis. Kidney biopsy is the standard for confirming lupus nephritis diagnosis, and a kidney biopsy delay longer than six months is associated with 9 times greater risk of progression to kidney failure. A person whose kidney degenerates to the point of kidney failure has a risk of premature death more than 60 times higher than normal. Therefore, patients should be actively and routinely screened for signs of the disease, and if diagnosed, immediately managed.

Patients with lupus nephritis who achieve a complete response as measured by decreases in proteinuria (protein in the urine) and a urine protein-to-creatinine ratio (UPCR) of less than 0.5 mg/mg can achieve better long term kidney outcomes such as avoidance of kidney failure, dialysis or need for transplantation which all have a severe impact on a person's health and quality of life, in addition to incurring significant healthcare system costs.

Tuba: Share the history behind your lead candidate, Lupkynis?

Neil: Aurinia has translated decades of research to develop and launch LUPKYNIS (voclosporin).

2014 marked the enrollment of the first patient in AURA-LV to evaluate the efficacy of voclosporin as a treatment for LN. The following year, Aurinia initiated an open-label, exploratory study to assess the short-term predictors of response using voclosporin in patients. By 2017, the Phase 3 AURORA clinical trial was underway and positive trial results were announced in December 2019 allowing for FDA submission in May of 2020. Priority review was designated in August 2020 and FDA approval granted in January 2021. Since then, LUPKYNIS represents the first FDA-approved oral therapy for active LN, with the potential to provide improved outcomes for a population with significant unmet treatment needs.

Tuba: What motivates the company to work on autoimmune diseases?

Neil: Autoimmune diseases are some of the most challenging and burdensome chronic diseases for global healthcare systems and on an individual level as they often have significant impacts on quality of life. Through scientific and clinical excellence, deep engagement with patient communities, and commercial expertise, Aurinia is committed to leadership in autoimmune disease to deliver long-term value to patients and the healthcare system.

Tuba: Discuss the study design and results of AURA-LV and AURORA 1 study.

Neil: i) AURA-LV

Phase 2 48-week studyDouble blind RCTN = 265Active control Primary endpoint: 24week renal responseSecondary endpoints: 48week renal response
AURORAPhase 3 52-week study double-blind RCTN = 357Active control Primary endpoint: 52week renal response

The positive benefit-risk profile observed in AURORA (n = 357) confirmed the treatment effect seen in AURA-LV (n = 265) when comparing voclosporin 23.7 mg BID in combination with background standard of care versus standard of care alone.

The odds of achieving Renal Response on voclosporin therapy were 2.65x greater than control while maintaining a favorable safety profile. The absolute risk reduction is 18.3%.

Tuba: Discuss Lupkynis in detail (its MOA, recommended dose, or Boxed warning if any)

Neil: LUPKYNIS is the first FDA-approved oral treatment for the treatment of adult patients with active LN. A novel, structurally modified calcineurin inhibitor (CNI), LUPKYNIS has a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The recommended starting dose of LUPKYNIS is three capsules twice daily with no requirement for serum drug monitoring. Dose modifications are made based on Aurinia's proprietary personalized eGFR based dosing protocol. Boxed Warning, warnings, and precautions for LUPKYNIS are consistent with those of other CNI-immunosuppressive treatments. Full prescribing information is available here.

Tuba: What is Aurinia's mission or focus in changing the treatment option for society?

Neil: People with lupus nephritis have desperately needed approved treatments to help them avoid irreversible kidney damage and the eventual need for a kidney transplant. LUPKYNIS represents a significant step forward in treating lupus nephritis and a much-needed therapeutic option for the lupus community.

Tuba: Are you open to collaborations to advance your treatments? If yes, how can one contact you?

Neil: Aurinia's mission is to transform people's lives by delivering therapeutics that change the course of autoimmune disease. We believe strong collaboration powers success at every level of drug development and commercialization. We are committed to forging welcome strategic partnerships aligned with this our mission to help advance groundbreaking therapies for people in need. For inquires related to strategic partnerships, please contact bd@auriniapharma.com.

Tuba: Give the key takeaways of your patient support program. Is Aurinia running or planning for any digital or innovative programs for HCP and patients to increase awareness and adherence?

Neil: Our patient support program, Aurinia Alliance, strives to provide people living with lupus nephritis and their care partners with personalized support, through education, tools, and resources. Patients can enroll to be connected with a Nurse Case Manager, who will be a dedicated contact to offer educational resources, and assistance navigating insurance and medication costs and other support in a patient treatment journey with Aurinia medicines.

Image Source: RD360

About Neil Solomons:

Neil Solomons co-founded privately held Aurinia Pharmaceuticals in 2012 and have served as Chief Medical Officer since its inception. He is a seasoned pharmaceutical physician with 18 years of clinical development and medical affairs experience in both large pharma and biotech.