Industry media BioPharma Dive recently published a feature report, selecting 10 potential clinical trials from numerous ongoing projects that are expected to announce results in the second half of this year. These trials focus on obesity, lung cancer, and atopic dermatitis.（AD）In multiple key treatment areas, some results have been gradually disclosed. These studies are expected to bring breakthrough progress to the entire biopharmaceutical industry, further promote medical innovation, and benefit more patients.

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Drug Name:Orforglipron（LY3502970）

Indications:Patients with obesity or overweight who have obesity-related comorbidities

Development Company:Eli Lilly and Company

Clinical Trial:Attain-1（NCT05869903）

Orforglipron is a once-daily oral, non-peptide GLP-1 receptor small molecule agonist developed by Eli Lilly.This drug is a non-peptide molecule, making it easier to manufacture and package into tablets. This characteristic may also help improve its affordability and accessibility for patients.ATTAIN-1 is a Phase 3, randomized, double-blind clinical study,To evaluate the efficacy and safety of once-daily oral orforglipron in adult patients with obesity or overweight accompanied by weight-related comorbidities.The study compared orforglipron with a placebo to observe its effectiveness and tolerability in weight loss. The preliminary results of the trialExpected to be announced in the third quarter of this year.

Drug Name:Amlitelimab

Indications:Atopic Dermatitis

Developer Company:Sanofi

Clinical Trial:Coast-1（NCT06130566）、SHORE（NCT06224348）

Amlitelimab, developed by Sanofi, is a monoclonal antibody targeting the OX40 ligand (OX40L).Compared with drugs that directly target the OX40 receptor, it can inhibit T-cell-dependent inflammation while avoiding the depletion of immune cells, potentially reducing immunosuppression-related side effects. In a Phase 2b clinical trial,Amlitelimab Significantly Improves Symptoms in Patients with Moderate-to-Severe Atopic Dermatitis at Weeks 16 and 24, Demonstrating Potential for Once Every 12 Weeks Dosing, which is expected to reduce the treatment burden for patients. Currently, the drug is undergoing several Phase 3 clinical trials, including the Coast-1 and SHORE trials, to further evaluate its efficacy and safety in patients aged 12 years and above with moderate to severe AD. Coast-1 is a parallel-group design monotherapy study that enrolls patients who have had an inadequate response to or are unsuitable for continued use of topical prescription medications; whereas SHORE evaluates the systemic treatment effect of amlitelimab in patients with inadequate treatment response under the context of treatment with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI). These two studies will provide critical evidence for the clinical value of amlitelimab as a novel therapeutic option for AD. BothPreliminary Results of the TrialExpected to be announced in the third quarter of this year.

Drug Name:Sonelokimab

Indications:Hidradenitis Suppurativa (hidradenitis suppurativa)

Developer Company:Moonlake Immunotherapeutics

Clinical Trial:Vela-1（NCT06411899）、Vela-2（NCT06411379）

Sonelokimab is a humanized nanobody with a molecular weight of approximately 40 kDa, composed of three covalently linked heavy chain variable domains of antibodies.Two of the protein domains can bind IL-17A and IL-17F with high affinity and selectivity, effectively blocking the inflammatory signaling pathways mediated by IL-17A/A, IL-17A/F, and IL-17F/F dimers; the third protein domain binds human albumin, which helps enrich the drug in inflamed and edematous areas, thereby enhancing local efficacy. To further validate its clinical potential in treating moderate to severe hidradenitis suppurativa, sonelokimab is currently undergoing two Phase 3 clinical trials, Vela-1 and Vela-2. Both studies are multicenter, randomized, double-blind, placebo-controlled trials that enroll adult patients with moderate to severe hidradenitis suppurativa, who are randomly assigned in a 2:1 ratio to receive either weekly subcutaneous injections of sonelokimab or placebo for up to 16 weeks. The aim is to systematically evaluate its efficacy and safety, providing a new treatment option for this refractory skin condition.

Drug Name:Ivonescimab

Indications:Non-Small Cell Lung Cancer (NSCLC)

Development Company:Summit Therapeutics, Akeso Bio

Clinical Trial:HARMONi（NCT06396065）

Ivonescimab is a bispecific antibody targeting PD-1 and VEGF.，Capable of simultaneously blocking the binding of PD-1 to its ligands PD-L1/PD-L2, as well as the binding of VEGF to its receptor, thereby synergistically inhibiting tumor immune escape and angiogenesis.Given the co-expression of VEGF and PD-1 in the tumor microenvironment, ivonescimab, through its single-agent dual-target mechanism, is expected to enhance antitumor activity more effectively than combination therapies while significantly reducing VEGF-related adverse reactions, demonstrating superior safety. The drug is currently undergoing the HARMONi clinical study, a randomized, double-blind, multicenter Phase 3 clinical trial designed to evaluate the efficacy and safety of ivonescimab in combination with pemetrexed and carboplatin for treating patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer. These patients have previously receivedEGFR Tyrosine Kinase Inhibitor (TKI)Treatment and disease progression. The study plans to enroll approximately 420 participants, randomized in a 1:1 ratio to receive either ivonescimab or placebo in combination with chemotherapy, followed by a maintenance treatment phase for up to two years. The results of this study are expected to be announced by the end of this year.

Drug Name:Fenebrutinib

Indications:Relapsing Multiple Sclerosis (RMS)

Developer Company:Roche

Clinical Trial:FENhance（NCT04586010）、FENhance 2（NCT04586023）

Fenebrutinib is an investigational oral, reversible, non-covalent Bruton's tyrosine kinase (BTK) inhibitor., which can block the key role of BTK in B-cell development and activation while regulating the activation of myeloid immune cells such as macrophages and microglia. The drug has high selectivity, with an inhibition selectivity for BTK that is 130 times higher than other kinases. This characteristic is expected to reduce off-target effects and enhance the safety of long-term use. In the open-label extension phase of the Phase 2 FENopta study, Roche's announced 48-week data showed,Up to 96% of RMS patients treated with fenebrutinib did not experience disease relapse or progression within one year.Demonstrated good efficacy and tolerability. Currently, the drug is undergoing two pivotal Phase 3 clinical trials, FENhance and FENhance 2, to further validate its clinical value in RMS. Both studies are multicenter, randomized, double-blind trials designed to evaluate the efficacy and safety of fenebrutinib compared to standard-of-care treatments in slowing disease progression and reducing relapse rates.

Drug Name:WVE-006

Indications:Alpha-1 Antitrypsin Deficiency (AATD)

Development Company:Wave Life Sciences 

Clinical Trial:RestorAATion-2（NCT06405633）

WVE-006 is a potential "first-in-class" RNA editing oligonucleotide therapy, based onWave Life SciencesThe exclusive AIMer platform can edit adenine to inosine (A-to-I) and achieve targeted liver delivery through subcutaneous injection by PN chemical modification and GalNAc conjugation.WVE-006 is designed to treat AATD patients.SERPINA1A single-base error in the gene that leads to the Z mutation can restore the expression of functional wild-type AAT protein and reduce the aggregation of harmful Z-AAT protein. This has the potential to be used for treating lung and/or liver diseases associated with AATD. The drug is currently being evaluated in the RestorAATion-2 study, which is a Phase 1b/2a, open-label,Single Ascending Dose (SAD)And MoreDose EscalationThe clinical trial designed by (MAD) enrolled Pi*ZZ type AATD patients, aiming to systematically evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetic characteristics of WVE-006. Last October,Wave Life SciencesAnnouncing the achievement of this researchPositive Results，WVE-006 successfully achieved proof of mechanism in patients. According to the press release at the time, this marked a key milestone as the first clinical proof of mechanism for RNA editing therapy in humans.CompanyThe multiple-dose data of this therapy is expected to be shared this year.

Drug Name:Evolocumab

Indications:Hyperlipidemia

Developer:Amgen

Clinical Trial:VESALIUS-CV（NCT03872401）

Studies show that elevated levels of low-density lipoprotein cholesterol (LDL-C) are one of the key modifiable risk factors for the development of cardiovascular disease (CVD).Evolocumab, as a PCSK9 inhibitor, accelerates the clearance of LDL-C by blocking the binding of PCSK9 to LDL receptors (LDLR) and enhancing the expression of LDLR on the surface of hepatocytes.Effectively reduce the risk of major cardiovascular events such as myocardial infarction and stroke. To further verify its cardiovascular protective effects in high-risk populations, evolocumab is currently undergoing the VESALIUS-CV study, a double-blind, randomized, placebo-controlled multicenter clinical Phase 3 trial. This trial aims to evaluate the drug's efficacy in reducing the incidence of major cardiovascular events in adult patients without a history of myocardial infarction or stroke but with a higher risk of cardiovascular events. The results of this trial are expected to be announced in the third quarter of this year.

Drug Name:VLA15

Indications:Lyme Disease (Lyme disease)

Developer Company:PfizerValneva

Clinical Trial:VALOR（NCT05477524）

VLA15 is a multivalent protein subunit vaccine under research, targeting the outer surface protein A (OspA) of Borrelia burgdorferi, which is a key antigen of the Lyme disease-causing bacterium within ticks.By antagonizing OspA, VLA15 is expected to block the transmission of the pathogen from ticks to humans.Previously announcedPhase 2 StudyResults showed that VLA15 demonstrated good immunogenicity and safety, particularly with stable immune responses maintained after the second booster dose.The vaccine is currently undergoing a Phase 3 clinical trial named VALOR. This large, placebo-controlled study aims to systematically evaluate the vaccine's efficacy, safety, tolerability, and immunogenicity. The trial plans to enroll approximately 9,400 healthy participants aged 5 years and above from regions with high incidences of Lyme disease. Participants will be randomly assigned in roughly a 1:1 ratio to receive either the VLA15 vaccine or a placebo. Some participants will also receive doses from different vaccine batches to assess batch-to-batch consistency. The vaccination schedule includes a three-dose primary series (administered at months 0, 2, and between months 5 to 9) and a booster dose (given approximately 12 months after the primary series), designed to cover two or even three consecutive Lyme disease seasons, allowing for a more comprehensive evaluation of the vaccine’s real-world protective effectiveness. Preliminary results from the study are expected to be released by the end of this year.

Drug Name:BHV-7000

Indications:Major Depressive Disorder (MDD)

Development Company:Biohaven

Clinical Trial:NCT06419608

BHV-7000 is developed byA product developed by BiohavenNovel, selective small-molecule therapies that activate Kv7.2/Kv7.3 potassium channels, which play a critical role in neural signal transmission and modulation of neuronal hyperexcitability., applicable for the treatment of diseases such as epilepsy and mood disorders. Previously released Phase 1 multi-dose escalation study data showed that the once-daily extended-release formulation of the drug demonstrated good tolerability at all dose levels.Currently, BHV-7000 is undergoing a Phase 2 clinical trial for the treatment of depression. This is a multicenter, randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy and safety of BHV-7000 as a monotherapy in patients with MDD. The study is expected to provide critical clinical data support for the potential application of this drug in the field of mood disorders.

Drug Name:mRNA-1010

Indications:Seasonal Influenza

Developer:Moderna

Clinical Trial:P304（NCT06602024）

mRNA-1010 is a seasonal influenza vaccine developed by Moderna based on mRNA technology, designed to provide broader and more efficient immune protection against multiple strains of influenza A and B.The vaccine is currently in Phase 3 pivotal clinical trials, with a focus on evaluating its safety, immunogenicity, and relative vaccine efficacy (rVE) compared to approved standard-dose inactivated influenza vaccines in adults aged 50 years and older. The study, named P304, is a randomized, observer-blinded, active-controlled, case-driven Phase 3 trial that enrolled over 40,000 participants who received a single dose of either mRNA-1010 or the control vaccine, followed by a median follow-up period of six months.The results showed，mRNA-1010 Met Predefined Stringent Superiority Criteria, Achieving 26.6% rVE (95% CI: 16.7%-35.4%) in the Overall Population, Demonstrating Robust Protection Across All Strains Including A/H1N1, A/H3N2, and B/Victoria.In addition, the rVE of this vaccine was 27.4% in people aged 65 and above, and it maintained a consistent advantage across subgroups of different ages, underlying health conditions, and vaccination backgrounds. The safety and tolerability of mRNA-1010 were good, with most adverse events being mild, consistent with findings from previous studies.

References:

[1] 10 clinical trials to watch the rest of 2025. Retrieved July 20, 2025 from https://www.biopharmadive.com/news/biotech-pharma-clinical-trials-watch-2025/736120/?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202025-06-30%20BioPharma%20Dive%20%5Bissue:74500%5D&utm_term=BioPharma%20Dive

[2] A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1). Retrieved July 20, 2025 from https://clinicaltrials.gov/study/NCT05869903?term=NCT05869903&rank=1

[3] A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 1). Retrieved from https://clinicaltrials.gov/study/NCT06130566?term=coast-1&rank=3

[4] A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids (SHORE). Retrieved July 20, 2025 from https://clinicaltrials.gov/study/NCT06224348?term=amlitelimab&page=2&rank=11

[5] A Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa. Retrieved July 20, 2025 from https://clinicaltrials.gov/study/NCT06411899?term=VELA-1&rank=1

[6] Phase III Study of AK112 for NSCLC Patients. Retrieved July 20, 2025 from https://clinicaltrials.gov/study/NCT06396065?term=Harmoni&aggFilters=phase:3&rank=1

[7] A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) (FENhance). Retrieved July 20, 2025 from https://clinicaltrials.gov/study/NCT04586010?term=NCT04586010&rank=1

[8] Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) (FENhance 2). Retrieved July 20, 2025 from https://clinicaltrials.gov/study/NCT04586023

[9] A Phase 1b/2a, Open-label Single Ascending Doses and Multiple Ascending Doses Study in Participants with Pi*ZZ AATD. Retrieved July 20, 2025 from https://clinicaltrials.gov/study/NCT06405633?term=NCT06405633%20&rank=1

[10] Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke (VESALIUS-CV). Retrieved July 20, 2025 from https://www.clinicaltrials.gov/study/NCT03872401

[11] An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15) (VALOR). Retrieved July 20, 2025 from https://www.clinicaltrials.gov/study/NCT05477524

[12] Efficacy and Safety Study of BHV-7000 Monotherapy in Major Depression. Retrieved July 20, 2025 from https://clinicaltrials.gov/study/NCT06419608

[13] Biohaven Presents New Data with BHV-7000 Once-Daily Extended-Release Formulation Demonstrating Excellent Safety Profile and Nonclinical Data Updates at American Epilepsy Society 2024 Annual Meeting. Retrieved July 20, 2025 from https://ir.biohaven.com/news-releases/news-release-details/biohaven-presents-new-data-bhv-7000-once-daily-extended-release

[14] A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age. Retrieved July 20, 2025 from https://clinicaltrials.gov/study/NCT06602024

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