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Primary Endpoint: UPCR Reduction Interim Analysis Set (IAS) included the first 203 randomized participants who received 1 dose of trial drug. Change from baseline in natural-log transformed UPCR at Week 36 was analyzed u

Key Takeaway: An interim analysis of the trial for Atacicept showed a 42% reduction in UPCR from baseline after 36 weeks, indicating promising efficacy in patients. The analysis included 203 participants who received Atacicept or placebo, revealing consistent efficacy across prespecified subgroups and generally favorable safety. Serious adverse events were lower in the Atacicept group, but some participants reported injection site reactions. No deaths occurred during the study, supporting the treatment's tolerability.
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POSITIVE FACTORS

  • Significant reduction in UPCR (42% change from baseline) with Atacicept.
  • Low rate of serious adverse events in the Atacicept group compared to placebo.
  • Overall tolerability is favorable with mild to moderate adverse events.

CONCERNS & RISKS

  • Some participants experienced injection site reactions.
  • A few adverse events led to drug discontinuations, though most were mild.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+38%
120-day peak, hindsight
Typical move
3.5%
average across 4 past catalysts
Cash runway
~15 mo
Low dilution risk
Lead asset
Atacicept
Phase 3 · IgA Nephropathy

Full Press Release Details

Corporate Presentation November 6,
Primary Endpoint: UPCR Reduction
Interim Analysis Set (IAS) included the first 203 randomized participants who received 1 dose of trial drug. Change from baseline in natural-log transformed UPCR at Week 36 was analyzed using a mixed-effects model with repeated measurement
(MMRM), including fixed effects for treatment group, visit as a categorical variable, treatment-by-visit interaction, baseline natural-log transformed UPCR, baseline eGFR category, SGLT2i use at baseline, and region, with participant as a random
effect. log-transformed change from baseline in UPCR was estimated with use of least-squares means. To facilitate interpretation of the result, the least-squares means estimate was back-exponentiated to obtain the equivalent geometric mean
percentage change. MMRM analysis included double-blind period data up to Week 36, regardless of treatment discontinuation or initiation of rescue treatment for IgAN or prohibited therapy; missing values after study withdrawal were imputed with jump
to reference (placebo) approach for 100 times. The Rubin rule was used to combine results estimated from each of 100 imputation datasets by MMRM analysis. Mean (95% CI) % Change from Baseline n= Placebo Atacicept Week 97 106 96 104 97 104 95 103
42% 95% CI 29, 52 p<0.0001 -46% 95% CI -53, -38 -7% 95% CI -19, 8 Placebo n=95 Atacicept n=103
Subgroup analyses were conducted using
the same imputed data sets and the same MMRM model as for the primary analysis for each subgroup category, separately. If the subgroup was one of the covariates in the model, the covariate was removed from the model statement when the model was
performed for the particular subgroup. UPCR Efficacy Consistent Across Prespecified Subgroups n (%) Mean UPCR % Change at Week 36 Mean UPCR % Reduction vs Placebo (95% CI) Atacicept Placebo Atacicept Placebo Overall 106 97 -46% -7% 42% (29, 52) Age,
years <40 48 (45) 49 (51) -44% +0.5% 45% (23, 60) 40 58 (55) 48 (50) -46% -14% 38% (21, 51) Sex Male 57 (54) 58 (60) -41% -9% 35% (14, 51) Female 49 (46) 39 (40) -51% -2% 50% (34, 62) Region Asia 50 (47) 48 (50) -50% -14% 42% (18, 58)
Other 56 (53) 49 (51) -42% +1% 43% (29, 55) Race White 46 (43) 42 (43) -42% +0.1% 42% (26, 55) Non-white 60 (57) 55 (57) -48% -11% 42% (22, 57) BL UPCR, g/g <1.5 53 (50) 47 (49) -44% +3% 46% (28, 59) 1.5 53 (50) 50 (52) -48% -13% 41% (21,
55) BL eGFR, mL/min/1.73m2 <60 50 (47) 52 (54) -35% -1% 34% (13, 51) 60 56 (53) 45 (46) -53% -14% 45% (27, 59) SGLT2i use at BL Yes 59 (56) 49 (51) -48% -7% 44% (26, 58) No 47 (44) 48 (50) -43% -6% 39% (19, 54) Mean UPCR % Reduction vs
Placebo at Week 36 (95% CI) Favors Atacicept Favors Placebo
Gd-IgA1 Reduction and Hematuria
Resolution Mean (95% CI) % Change from Baseline1 97 104 95 101 n= Placebo Atacicept Week 94 100 93 96 93 103 -3% 4 Gd-IgA1 Reduction -68% 67% p<0.0001 Change from Baseline in % Patients with Hematuria (95% CI)2 Week 58 64 58 63 58 64 58 64
-81% -21% Odds ratio 19.1 p<0.0001 Hematuria Resolution 58 64 4 58 61 2 Analysis included all data up to Week 36 analyzed according to treatment policy strategy. Missing data were handled implicitly by statistical model. Nominal p-values are
presented. 1. Change from baseline in natural log-transformed Gd-IgA1 was analyzed using MMRM similar to that for the primary endpoint. 2. Percentages represent change from baseline in number of participants with hematuria (urine dipstick blood
1+) at each visit divided by number of participants with baseline hematuria shown on the lower axis; resolution defined as urine dipstick blood of trace or negative. Odds ratio is calculated from a logistic regression model adjusted for
covariates. eGFR results not disclosed per FDA recommendation to sponsors of IgAN registrational trials
Adverse Events Generally Balanced
Between Groups Most adverse events were mild or moderate in severity Rate of serious adverse events was lower in the atacicept group compared with placebo No deaths occurred Participants, n (%) Atacicept n=214 Placebo n=214 Adverse events 127 (59)
107 (50) Serious adverse events1 1 (0.5) 11 (5) Adverse events leading to drug discontinuation2 2 (1) 8 (4) Adverse events of infections and infestations 68 (32) 60 (28) Serious or severe infections and infestations 0 3 (1) Opportunistic infections
0 0 Study drug related adverse events3 63 (29) 22 (10) Adverse events associated with injection site reactions4 51 (24) 11 (5) Hypersensitivity reactions 8 (4) 14 (7) Adverse events leading to death 0 0 Analysis of safety population (all
participants randomized and treated) as of interim data cut on 15-May-2025. Atacicept: cholecystitis, determined by site investigator to be unrelated to treatment; Placebo (n=1 each): gastroenteritis, lower respiratory tract infection, pneumonia,
pyelonephritis, IgA nephropathy, renal impairment, acute myocardial infarction, transplant rejection, hyponatremia, osteonecrosis, ovarian epithelial cancer, carotid artery aneurysm, hypertension, acute cholecystitis. 1 placebo serious adverse event
was deemed related to study drug. Discontinuations in the 2 atacicept participants were due to eczema and erythema. Majority were mild to moderate injection site reactions that did not lead to discontinuation. Injection site reactions among
atacicept recipients were largely characterized by injection site erythema, bruising, and pruritis. No observed hypogammaglobulinemia (IgG <3 g/dL).

Frequently Asked Questions

What was the primary endpoint of the trial?

The primary endpoint was the reduction in UPCR.

How many participants were included in the Interim Analysis Set?

The Interim Analysis Set included the first 203 randomized participants.

What statistical method was used for analyzing UPCR change?

A mixed-effects model with repeated measures (MMRM) was used.

How did Atacicept perform compared to placebo?

Atacicept showed a 46% reduction vs. a 7% reduction for placebo.

What was the rate of serious adverse events in the Atacicept group?

The Atacicept group had one serious adverse event, significantly lower than placebo.

Last updated: Nov 6, 2025