Johnson & Johnson Submits MAA to EMA for Icotrokinra, While Galimedix Reports Positive Phase 1 Data for First-in-Class Oral Alzheimer’s Candidate GAL-101

One of the Top Ten Star Molecules! Oral Peptide Submits Marketing Application to the EU

Johnson & Johnson recently announced that it has submitted an application to the European Medicines Agency (EMA),Seeking itsAndCo-developed by Protagonist TherapeuticsThe investigational, once-daily oral peptide therapy icotrokinra (JNJ-2113) has been approved for marketing to treat adult and pediatric patients aged 12 years and older with moderate to severe plaque psoriasis (PsO).Johnson & Johnson had submitted this therapy to the U.S. FDA in July this year.Submit New Drug Application（NDA）, used to treat the same indications. Notably,It was named by the well-known industry media Drug Hunter as one of the 2024 annualTop Ten Star MoleculesOne of.

Topline positive results from the pivotal Phase 3 ICONIC-LEAD study, announced in April this year, showed that once-daily icotrokinra significantly improved skin conditions in patients with moderate to severe plaque psoriasis, with a favorable safety profile. At week 16,65% of patients in the icotrokinra group achieved an Investigator Global Assessment (IGA) score of 0/1 (clear or almost clear skin symptoms), and 50% of patients achieved at least a 90% improvement in the Psoriasis Area and Severity Index (PASI 90)., whereas the values for these two indicators in the placebo group were only 8% and 4%, respectively. By week 24, the patient remission rate further improved, with 74% of patients achieving an IGA score of 0/1 and 46% reaching IGA 0; 65% of patients achieved PASI 90 and 40% reached PASI 100.

Icotrokinra is a potential "first-in-class" targeted oral peptide that can selectively block the IL-23 receptor (IL-23R).IL-23 plays a key role in the pathogenic T-cell activation in moderate to severe plaque PsO and is fundamental to the inflammatory response in PsO and other dermatological, rheumatological, and IL-23-mediated gastrointestinal diseases. Icotrokinra can bind to IL-23R with single-digit picomolar affinity and exerts potent selective inhibition of IL-23 signaling in human T cells.

Crossing the Blood-Brain Barrier! Positive Results Announced for Potential “First-in-Class” Alzheimer’s Therapy

Galimedix Therapeutics Announces Successful Completion of Phase 1 Clinical Trial for Potential "First-in-Class" Investigational Oral Small Molecule GAL-101. Study results show that GAL-101 was well-tolerated, with clinical safety established.No abnormal amyloid imaging (ARIA) or other serious adverse events (SAEs) were observed.). Consistent with the preclinical study results,GAL-101 can effectively cross the blood-brain barrier., whose pharmacokinetic (PK) characteristics also provide strong support for advancing its oral formulation into Phase 2 clinical trials for Alzheimer's disease.

GAL-101 prevents the formation of toxic Aβ oligomers and fibrils by targeting misfolded β-amyloid (Aβ) monomers.In addition to oral formulations, the therapy is also being developed for topical use. Galimedix Therapeutics is currently conducting a Phase 2 clinical study of GAL-101 eye drops for dry age-related macular degeneration (dAMD), with patient recruitment ongoing.

Potential "First-in-Class" Small Molecule Positive Clinical Data Released

MAIA Biotechnology Recently Announced Positive Efficacy Data from Its Phase 2 Clinical Trial THIO-101, Which Evaluates the Sequential Treatment of Ateganosine (THIO) and PD-1 Inhibitor Libtayo (Cemiplimab) in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Who Have Failed Two or More Standard Therapies. As of June 30, 2025,The median progression-free survival (PFS) for third-line treatment (180 mg dose) was 5.6 months, and the median overall survival (OS) was 17.8 months.In addition, among patients across all treatment lines,Two patients have completed 33 cycles of treatment, further highlighting the potential of ateganosine for long-term administration., which is typically associated with longer patient survival.

Ateganosine is an investigational, potential "first-in-class" telomere-targeting anticancer drug.Ateganosine induces telomerase-dependent telomeric DNA modification, DNA damage response, and selective cancer cell death. Telomere fragments damaged by ateganosine accumulate in cytoplasmic micronuclei and activate innate and adaptive immune responses. By inducing cancer-specific immune memory, sequential treatment with ateganosine followed by PD-1/PD-L1 inhibitors leads to significant and sustained tumor regression in advanced cancer animal models. The drug has been granted Orphan Drug Designation by the U.S. FDA.

References:

[1] Johnson & Johnson seeks first European Medicines Agency approval for icotrokinra aiming to transform the plaque psoriasis treatment paradigm. Retrieved September 12, 2025 from https://www.globenewswire.com/news-release/2025/09/11/3148479/0/en/Johnson-Johnson-seeks-first-European-Medicines-Agency-approval-for-icotrokinra-aiming-to-transform-the-plaque-psoriasis-treatment-paradigm.html

[2] MAIA Biotechnology Highlights Positive Efficacy Data from THIO-101 Phase 2 Clinical Trial in Non-Small Cell Lung Cancer. Retrieved September 12, 2025 from https://www.globenewswire.com/news-release/2025/09/11/3148625/0/en/MAIA-Biotechnology-Highlights-Positive-Efficacy-Data-from-THIO-101-Phase-2-Clinical-Trial-in-Non-Small-Cell-Lung-Cancer.html

[3] Progress in clinical development for Alzheimer’s and other indications: Galimedix Therapeutics successfully completes Phase 1 study with oral small molecule, GAL-101, an amyloid beta aggregation modulator. Retrieved September 12, 2025 from https://www.globenewswire.com/news-release/2025/09/12/3149131/0/en/Progress-in-clinical-development-for-Alzheimer-s-and-other-indications-Galimedix-Therapeutics-successfully-completes-Phase-1-study-with-oral-small-molecule-GAL-101-an-amyloid-beta-.html