Aurinia Pharmaceuticals to Present Five Abstracts at ASN Kidney Week 2021 and ACR Convergence 2021

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Knowledge to spotlight the security, tolerability and efficacy of LUPKYNIS in sufferers with lupus nephritis

VICTORIA, British Columbia — Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Firm), a biopharma firm dedicated to delivering therapeutics that change the course of autoimmune illness, at present introduced that knowledge from a number of research of LUPKYNIS™ (voclosporin) for the therapy of individuals with lupus nephritis (LN), a critical complication of systemic lupus erythematosus (SLE) leading to probably life-threatening harm to the kidneys, will likely be introduced at American Society of Nephrology (ASN) Kidney Week 2021 and at American School of Rheumatology (ACR) Convergence 2021. ASN Kidney Week will happen just about on November 2-7 and ACR Convergence will happen just about on November 3-9.

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“Aurinia is dedicated to rising the physique of scientific analysis supporting LUPKYNIS as a secure and efficient possibility for folks with lupus who’re combating to guard their kidneys from the damaging influence of lupus nephritis,” stated Neil Solomons, M.D., Chief Medical Officer at Aurinia. “We sit up for presenting new knowledge for LUPKYNIS at ASN and ACR, together with an up to date interim evaluation of knowledge from the AURORA 2 continuation research evaluating the long-term security and tolerability of LUPKYNIS.”

The accepted summary shows and posters are listed under and might be seen just about from November 4-6 at ASN and from November 8-9 at ACR . The main points are listed as follows.

Digital ASN Kidney Week 2021 Displays and Posters:

Thursday, November 4, 2021

Title: “Power Dosing of Voclosporin at Clinically Related Publicity Ranges Does Not Induce Renal Fibrosis Markers in Rats”
Presenting writer: Linda M. Rehaume, Ph.D., senior analysis scientist at Aurinia
Time : Out there on-demand starting at 10:00 a.m. PDT

Saturday, November 6, 2021

Title: “Voclosporin is Efficient in Attaining Full Renal Response in Extreme Lupus Nephritis”
Presenting writer: Hanni Menn-Josephy, M.D., Boston Medical Heart
Time : 4:30 p.m. – 5:30 p.m. PDT

Digital ACR Convergence 2021 Displays and Posters:

Monday, November 8, 2021

Title: “ Voclosporin for Lupus Nephritis: Interim Evaluation of the AURORA 2 Extension Examine”
Presenting writer: Amit Saxena, M.D., NYU Faculty of Medication
Session: Plenary III (1424–1429)
Time : 10:45 a.m. – 11:00 a.m. EST

Tuesday, November 9, 2021

Title: “ Voclosporin is Efficient in Attaining Full Renal Response Throughout Lupus Nephritis Biopsy Lessons: Pooled Knowledge from the AURA-LV and AURORA 1 Trials”
Presenting writer: Anca Askanase, M.D., M.P.H., Columbia College Medical Heart
Session : SLE – Therapy Poster (1732–1772)
Time : 8:30 a.m. – 10:30 a.m. EST

Title: “Efficacy of Voclosporin in Latest Onset Lupus Nephritis”
Presenting writer: Meggan Mackay, M.D., M.S., Feinstein Institute for Medical Analysis
Session : SLE – Therapy Poster (1732–1772)
Time : 8:30 a.m. – 10:30 a.m. EST

About Lupus Nephritis

Lupus nephritis (LN) is a critical manifestation of systemic lupus erythematosus (SLE), a persistent and complicated autoimmune illness. About 200,000-300,000 folks dwell with SLE within the U.S. and roughly one out of three of those people develop LN. If poorly managed, LN can result in everlasting and irreversible tissue harm throughout the kidney, leading to kidney failure. Black and Asian people with SLE are 4 instances extra more likely to develop LN and people of Hispanic ancestry are roughly twice as more likely to develop the illness when put next with Caucasian people. Black and Hispanic people with SLE additionally are inclined to develop LN earlier and have poorer outcomes when in comparison with Caucasian people.

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About LUPKYNIS

LUPKYNIS™ is the primary FDA-approved oral medication for the therapy of grownup sufferers with lively lupus nephritis (LN). LUPKYNIS is a novel, structurally modified calcineurin inhibitor (CNI) with a twin mechanism of motion, appearing as an immunosuppressant by way of inhibition of T-cell activation and cytokine manufacturing and selling podocyte stability within the kidney. The advisable beginning dose of LUPKYNIS is three capsules twice each day with no requirement for serum drug monitoring. Dose modifications might be made primarily based on Aurinia’s proprietary customized eGFR-based dosing protocol. Boxed Warning, warnings and precautions for LUPKYNIS are in step with these of different CNI-immunosuppressive therapies.

About Aurinia

Aurinia is a totally built-in biopharmaceutical firm centered on delivering therapies to deal with focused affected person populations which are impacted by critical illnesses with a excessive unmet medical want. The Firm not too long ago launched the primary FDA-approved oral remedy indicated for the therapy of grownup sufferers with lively lupus nephritis (LN). Aurinia’s head workplace is in Victoria, British Columbia; its U.S. business hub is in Rockville, Maryland; and the Firm focuses improvement efforts globally.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATIONS

LUPKYNIS is indicated together with a background immunosuppressive remedy routine for the therapy of grownup sufferers with lively LN. Limitations of Use: Security and efficacy of LUPKYNIS haven’t been established together with cyclophosphamide. Use of LUPKYNIS just isn’t advisable on this scenario.

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS

Elevated danger for creating malignancies and critical infections with LUPKYNIS or different immunosuppressants which will result in hospitalization or loss of life.

CONTRAINDICATIONS

LUPKYNIS is contraindicated in sufferers taking sturdy CYP3A4 inhibitors due to the elevated danger of acute and/or persistent nephrotoxicity, and in sufferers who’ve had a critical/extreme hypersensitivity response to LUPKYNIS or its excipients.

WARNINGS AND PRECAUTIONS

Lymphoma and Different Malignancies: Immunosuppressants, together with LUPKYNIS, improve the chance of creating lymphomas and different malignancies, notably of the pores and skin. The danger seems to be associated to rising doses and period of immunosuppression slightly than to using any particular agent.

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Severe Infections: Immunosuppressants, together with LUPKYNIS, improve the chance of creating bacterial, viral, fungal, and protozoal infections (together with opportunistic infections), which can result in critical, together with deadly, outcomes.

Nephrotoxicity: LUPKYNIS, like different CNIs, might trigger acute and/or persistent nephrotoxicity. The danger is elevated when CNIs are concomitantly administered with medication related to nephrotoxicity.

Hypertension: Hypertension is a typical adversarial response of LUPKYNIS remedy and should require antihypertensive remedy.

Neurotoxicity: LUPKYNIS, like different CNIs, might trigger a spectrum of neurotoxicities: extreme embrace posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others embrace tremor, paresthesia, headache, and adjustments in psychological standing and/or motor and sensory features .

Hyperkalemia: Hyperkalemia, which can be critical and require therapy, has been reported with CNIs, together with LUPKYNIS. Concomitant use of brokers related to hyperkalemia might improve the chance for hyperkalemia.

QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent method when dosed larger than the advisable lupus nephritis therapeutic dose. Using LUPKYNIS together with different medication which are recognized to lengthen QTc might end in clinically important QT prolongation.

Immunizations: Keep away from using dwell attenuated vaccines throughout therapy with LUPKYNIS. Inactivated vaccines famous to be secure for administration might not be sufficiently immunogenic throughout therapy with LUPKYNIS.

Pure Crimson Cell Aplasia: Circumstances of pure purple cell aplasia (PRCA) have been reported in sufferers handled with one other CNI immunosuppressant. If PRCA is identified, take into account discontinuation of LUPKYNIS.

Drug-Drug Interactions: Keep away from co-administration of LUPKYNIS and powerful CYP3A4 inhibitors or with sturdy or average CYP3A4 inducers. Scale back LUPKYNIS dosage when co-administered with average CYP3A4 inhibitors. Scale back dosage of sure P-gp substrates with slim therapeutic home windows when co-administered.

ADVERSE REACTIONS

The commonest adversarial reactions (>3%) had been glomerular filtration charge decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract an infection, stomach ache higher, dyspepsia, alopecia, renal impairment, stomach ache, mouth ulceration, fatigue, tremor, acute kidney harm, and decreased urge for food.

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SPECIFIC POPULATIONS

Being pregnant/Lactation: Could trigger fetal hurt. Advise to not breastfeed.

Renal Impairment : Not advisable in sufferers with baseline eGFR ≤45 mL/min/1.73 m ² until profit exceeds danger. Extreme renal impairment: Scale back LUPKYNIS dose.

Delicate and Reasonable Hepatic Impairment : Scale back LUPKYNIS dose. Extreme hepatic impairment: Keep away from LUPKYNIS use.

Please see Prescribing Information , together with Boxed Warning , and Medication Guide for LUPKYNIS.

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Contacts

Media:
Dana Lynch
Company Communications, Aurinia
dlynch@auriniapharma.com

Buyers:
IR@auriniapharma.com