Delving into the Latest Updates on Sibeprenlimab with Synapse

The new European Union clinical trials regulation (EU CTR 536/2014) became effective on 31 January 2022. It introduced the novel concept of Auxiliary Medicinal Products (AxMPs) to be implemented in clinical trials in Europe. Otsuka submitted a Clinical Trial Application (CTA) under EU CTR for one of the ongoing clinical trials. The present manuscript discusses our approach to meeting the regulatory mandates for safety reporting requirements of AxMPs.

Objective::

The aim of this study was to understand the changes introduced under the new EU CTR 536/2014 with respect to AxMP requirements, implement the new regulatory mandates for AxMPs, raise awareness among the sponsors on collection, analysis, and reporting obligation of adverse events (AEs) to AxMPs.

Methods::

Using the cross-functional approach to incorporate new methods for collecting, reporting, and assessing adverse events with AxMPs, we identified the commonly prescribed Ax- MPs used to treat the target indication. We also updated our pharmacovigilance (PV) system [safety database] set up to ensure appropriate AxMP-related case processing and reporting.

Results::

Based on impact assessment, PV processes related to safety data collection and submissions were updated to reflect EU CTR requirements for AxMPs. The study documents were updated to comply with AxMP-related regulatory obligations. World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) code level 4 was used to classify relevant AxMPs. Study drug configurations and user-defined field customizations were made to the safety database.

result::

Based on impact assessment, PV processes related to safety data collection and submissions were updated to reflect EU CTR requirements for AxMPs. The study documents were updated to comply with AxMP-related regulatory obligations. World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) code level 4 was used to classify relevant AxMPs. Study drug configurations and user-defined field customizations were made to the PV system.

Conclusion::

From the gap analysis and impact assessment of EU CTR, appropriate changes were made to the existing PV processes, study-specific documents, and the safety database to ensure compliance with the EU CTR.

01 Feb 2025·Aging medicine (Milton (N.S.W))

Article

Author: Zuo, Li ; Liu, Xin

Sibeprenlimab is a humanized IgG2 monoclonal antibody that binds to and neutralizes the activity of APRIL. It should usher in a new era in the treatment of IgAN, especially in elderly patients.

01 Jan 2025·Revue medicale suisse

Néphrologie : ce qui a changé en 2024 (II)

Article

Author: De Seigneux, Sophie ; Bourdon, Fanny ; Jaques, David ; Haidar, Fadi ; Saudan, Patrick ; Baldet, Kadiatou

Certain molecules, such as GLP-1 agonists and endothelin antagonists, possess nephroprotective properties. When treating IgA nephropathy, endothelin antagonists and sibeprenlimab have shown effectiveness in slowing the progression of chronic kidney isease. Additionally, the infusion of amino acids can reduce the incidence of mild acute kidney injury following cardiac surgery. In hemodialysis, the sodium content in the dialysate appears to affect patient mortality rates. For individuals starting hemodialysis after the age of 75, there is a modest survival benefit, although it comes at the cost of reduced time spent at home. In the future, noninvasive biomarkers may enable early detection of renal graft rejection.

32

News (Medical) associated with Sibeprenlimab

13 Jun 2025

·www.fiercepharma.com

Fierce Pharma Asia—Pfizer CEO talks bispecific deal; Otsuka's kidney disease win; Novartis-MSN Entresto feud

Pfizer CEO’s remarks on the PD-1xVEGF deal, Otsuka’s phase 3 IgAN win and the ongoing Entresto patent fight between Novartis and MSN made headlines this week. Pfizer's CEO discussed the extensive due diligence the company has conducted on the 3SBio PD-1xVEGF deal. Otsuka detailed its phase 3 data in the kidney disease immunoglobulin A nephropathy (IgAN). Novartis is pressing for a speedy ruling in its Entresto patent litigation against MSN Pharmaceuticals.1. Pfizer CEO talks Chinese due diligence, ADC synergies to justify $6B bet on 'fabulous' bispecificPfizer CEO Albert Bourla said the company was “very careful” with due diligence before signing the 3SBio PD-1xVEGF bispecific deal. “We didn't do due diligence in a data room. We sent people on-site. We feel very comfortable. I met the CEO. They are credible guys,” he said. Pfizer sees the med’s potential to displace PD-1/L1 checkpoint inhibitors and combine with its portfolio of antibody-drug conjugates.2. Otsuka's kidney disease drug halves UPCR levels in phase 3 studyOtsuka unveiled detailed data from a phase 3 win in the kidney disease IgAN. Patients who received the company’s sibeprenlimab, an APRIL blocker, reported a 51.2% reduction in proteinuria from baseline when compared to placebo. The effect was measured by patients’ urine protein-to-cretinine ratio levels. The drug has an FDA target action date for IgAN on Nov. 28.3. Novartis presses court for hasty decision in long-running Entresto patent feud with MSNNovartis is still trying to block the launch of MSN Pharmaceuticals’ proposed Entresto generic. In a patent case, the Swiss drugmaker is asking a federal court in Delaware to issue a final decision before July 15, when a pediatric exclusivity period is set to expire. The Indian company is currently barred from launching until July 16.4. GSK offloads shigella vaccine to Bharat ahead of phase 3, vows to support fundraisingGSK has licensed its shigella vaccine candidate, altSonflex1-2-3, to Bharat Biotech before the start of a phase 3 trial. GSK said it will help Bharat design the phase 3 study and support its partner’s search for external funding. The British pharma framed the deal as a way to get the shot to patients in low- and middle-income countries, where the bacteria is responsible for the deaths of tens of thousands of children from diarrhea.5. Growing Astellas looks to reap the rewards of uniting commercial strategy, medical affairs: execClaus Zieler recently picked up the medical affairs officer title in addition to his existing role of chief commercial officer at Astellas. He said the move to unite the two functions was “almost natural” so that a doctor or a medical team can interact with “one Astellas” when needing support or information. Healthcare professionals are engaging with several different digital channels, leaving drugmakers like Astellas to learn how to cater to each in a unique way.Other News of Note: 6. WuXi Biologics breaks ground on microbial production plant in China7. Samsung Biologics inks $75M CDMO deal with European pharma firm (Korea Biomedical Review)8. Samsung Bioepis taps NIPRO to commercialize multiple biosimilars in Japan (release)

Phase 3Clinical Result

09 Jun 2025

·pmlive.com

Otsuka shares promising phase 3 results for sibeprenlimab in rare kidney disease IgAN

Otsuka Pharmaceutical has shared positive results from a late-stage study of its investigational monoclonal antibody sibeprenlimab in adults with the rare kidney disease immunoglobulin A nephropathy (IgAN). The phase 3 VISIONARY study, which Otsuka said is the largest IgAN trial to date, has been comparing the candidate against placebo in approximately 510 patients who were receiving standard-of-care therapy. IgAN occurs when the IgA protein accumulates in the kidneys and damages them. This impedes their filtering function and, as a result, the kidneys start to let substances such as blood and protein leak into the urine. The disease typically appears in adults aged 20 to 40 years and can lead to end-stage kidney disease over the lifetime of most patients. Results presented at this year’s European Renal Association Congress showed that patients treated with sibeprenlimab, administered subcutaneously every four weeks, achieved a 51.2% reduction in excess protein in the urine (proteinuria) compared to placebo at nine months. The safety profile of sibeprenlimab was also found to be favourable and consistent with previously reported data, Otsuka said, with 76.3% of sibeprenlimab-treated patients experiencing any treatment emergent adverse event compared to 84.5% in the placebo group. John Kraus, executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, said: “Proteinuria control is an important independent predictor for long-term prognosis, and this interim data reinforces our belief that selectively targeting APRIL [a cytokine in the tumour necrosis factor family] has the potential to be an effective and safe approach for this progressive and irreversible kidney disease.” VISIONARY will continue to evaluate change in kidney function over two years, as measured by estimated glomerular filtration rate, and is expected to be completed early next year. Sibeprenlimab has already been granted Priority Review designation by the US Food and Drug Administration, with a target action date of 28 November 2025. “The safety data emerging from VISIONARY is reassuring and adds to our existing knowledge about sibeprenlimab’s safety profile from prior programmes,” said Dana Rizk, professor of medicine in the division of nephrology at the University of Alabama at Birmingham. “This is very exciting news for patients and adds a therapeutic option with a novel mechanism of action potentially targeting the immunologic pathogenesis of IgAN.”

Clinical ResultPhase 3Priority ReviewImmunotherapy

09 Jun 2025

·www.biospace.com

Apellis, Sobi See Potential ‘Best-in-Class’ Efficacy for Empaveli in Rare Kidney Diseases

iStock, Phira Phonruewiangphing Empaveli reduced proteinuria by 68% versus placebo in glomerulopathy and glomerulonephritis, an effect that was sustained through one year of follow-up. Apellis and Sobi’s complement regulator Empaveli—sold under the brand name Aspaveli in Europe—sustained the reduction of proteinuria in patients with C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis through one year in a Phase III trial , potentially bolstering the drug’s case ahead of a July PDUFA date. Analysts at William Blair said in a Monday note that the new data continue to support Empaveli’s “game-changing profile” in the two rare kidney diseases. "[Empaveli] has best-in-class efficacy that should drive significant adoption in this underserved population over time,” the analysts wrote. In the Phase III VALIANT trial, Empaveli lowered proteinuria by 68% versus placebo at 28 weeks, an effect the partners claimed was statistically significant. Empaveli, they added, was able to sustain this benefit through one year of follow-up. Kidney function, as measured by estimated glomerular filtration rate, also stabilized in patients treated with Empaveli. The development partners presented the data during a late-breaking session at the European Renal Association Congress. VALIANT enrolled nearly 125 patients 12 years and up who had been diagnosed with C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN)—both rare kidney diseases characterized by inflammation in the organ linked to excessive deposits of the C3 complement protein. Both diseases can ultimately lead to kidney failure in half of patients within 10 years of diagnosis. Designed to be injected under the skin, Empaveli inhibits the immune system’s complement cascade, a part of the body’s immune system. This mechanism of action won the drug an FDA approval in May 2021 in paroxysmal nocturnal hemoglobinuria. European approval came a few months later . Apellis, which partnered with Sobi in October 2020 to bring the drug to ex-U.S. markets, has since worked to expand Empaveli’s label. In April, the biotech announced that the FDA accepted its application to use Empaveli in C3G and IC-MPGN and granted the drug Priority Review. A verdict is expected by July 28. Elsewhere in the kidney disease space, Otsuka also revealed promising data on Friday for its antibody therapy sibeprenlimab. Late-stage results in patients with immunoglobulin A nephropathy showed that sibeprenlimab could reduce proteinuria by 51.2% versus placebo—an effect that Guggenheim Partners called “impressive” in a Friday note. Sibeprenlimab, they continued, showed “the strongest numerical result reported to date in IgAN Phase 3 trials.” Otsuka has yet to detail out its regulatory plans for sibeprenlimab, though the company on Friday emphasized that “proteinuria reduction is a recognized surrogate marker” and “has been used as an endpoint in IgAN clinical trials to support accelerated regulatory approvals.”

Clinical ResultPhase 3Drug ApprovalPriority Review

100 Deals associated with Sibeprenlimab

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Glomerulonephritis, IGA	NDA/BLA	United States	Otsuka Pharmaceutical Co., Ltd.	31 Mar 2025
Sjogren's Syndrome	Phase 2	United States	Otsuka Pharmaceutical Development & Commercialization, Inc.	15 Apr 2025

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05248646 (VISIONARY, NEWS) Manual	Phase 3	Glomerulonephritis, IGA	320	Sibeprenlimab	bpykddjhfi(axjahyijth) = mfusyugdvo lyolrrphbt (liruoduvky ) View more	Positive	11 Jun 2025
				Placebo	bpykddjhfi(axjahyijth) = dojeeqfmxn lyolrrphbt (liruoduvky ) View more
NCT03719443 (VIS649, CTgov)	Phase 1	Glomerulonephritis, IGA	51	placebo (Pooled Placebo)	estbattjpy = ebkqjpnspx eomtdqiurz (wuowdmhpmf, zgzagiaysd - fbupaenqnb) View more	-	20 Mar 2025
				VIS649 (VIS649 Cohort 1)	estbattjpy = ujejagujkk eomtdqiurz (wuowdmhpmf, rkzzmervuz - rhvxnacetd) View more
NCT04287985 (VIS649-201, CTgov)	Phase 2	Glomerulonephritis, IGA	155	Dose-Placebo	dvyghmvjsq = gvvipwzxow fsjyjiplsy (qcqcfaqwzl, tlfhqsuklo - bjwaqzdicm) View more	-	21 Nov 2024
NCT05248646 (VISIONARY, Company_Website) Manual	Phase 3	Glomerulonephritis, IGA	530	sibeprenlimab	xvavlfgfmv(rdetyzupwg) = sibeprenlimab demonstrated a statistically significant and clinically meaningful reduction in 24-hour uPCR after nine months of treatment. ftnvgcaoyy (jedpzxsrbq ) Met View more	Positive	22 Oct 2024
				Placebo
NCT04287985 (VIS649-201, Pubmed \| NEWS \| Br Dent J) Manual	Phase 2	Glomerulonephritis, IGA	155	sibeprenlimab	uxpfrkqvwk(pwasjtuiek) = icynlueyct tlltshkden (uspusplswo, 8.2) View more	Positive	02 Nov 2023
				sibeprenlimab	uxpfrkqvwk(pwasjtuiek) = lnwomohrgj tlltshkden (uspusplswo, 6.1) View more
NCT04287985 (VIS649-201, ISN WCN2023)	Phase 2	Glomerulonephritis, IGA Gd-IgA1 \| APRIL \| total IgA ... View more	72	Sibeprenlimab	xezzzjfrqh(kirjqmumfe) = qbxkhhxflh ohdtrbppox (wlascpqvjk, 11) View more	Positive	01 Mar 2023
NCT03719443 (ERA2021) Manual	Phase 1	Diphtheria \| Tetanus	14	VIS649	fhdmolozca(nkosjfgdre) = egnhjqifbp bstswgzxzt (bmtiuhrvef ) View more	Positive	17 Sep 2021
				Placebo	fhdmolozca(nkosjfgdre) = skjvibulnd bstswgzxzt (bmtiuhrvef ) View more
NCT03719443 (VIS649, ASN2017)	Phase 1	Glomerulonephritis, IGA IgA \| IgG \| IgM	4	VIS649 25 mg/kg	mxbfyifjda(cxfznymffh) = lynwbdjznz yspxiktnfu (pufytvaoxh )	Positive	31 Oct 2017

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