Top 10 most promising drug trial data

There are many potential blockbuster drugs on the 2022 forecast list.
Many compounds are high-risk, high-return drug candidates, trying to break through the boundaries of drug therapy, including new technologies such as CRISPR, RNAi interference, and gene therapy
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From 2021 to 2022, the following promising drug candidates are expected to produce important data results in the coming year: 01 Eli Lilly/Roche Alzheimer's disease drug donanemab A few days ago, Eli Lilly has begun rolling applications for its drug candidate donanemab
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This submission is based on Phase 2 data, using the removal of amyloid plaques as a surrogate marker of clinical efficacy
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Eli Lilly hopes to obtain approval for the drug by the end of 2022, and is conducting a confirmatory phase 3 trial and a prevention study at the same time
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Next year, we should see preliminary data from the high-risk, head-to-head trials of donanemab and Bojian Aduhelm
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If donanemab can beat Aduhelm, and Eli Lilly is also smart in pricing, then it may beat this leading approved competitor, although donanemab may have to face the same voices that have been questioned like Bojian
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In addition, Roche is also conducting a Phase 3 trial of its amyloid-targeted drug durvalumab, which is expected to be released in the second half of 2022
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A few years ago, durvalumab failed the phase 3 trial, but Roche said that higher doses can improve its efficacy in removing amyloid
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02 CRISPR/Vertex Gene Therapy CTX001 CRISPR Therapeutics and Vertex are competing with BluebirdBio to introduce one-time gene therapy for rare blood diseases sickle cell disease (SCD) and β-thalassemia into the US market
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CRISR and Vertex have been continuously and steadily releasing data updates for their gene editing therapy CTX0011/2 phase trial
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Since all the subjects in these studies are now enrolled, they are waiting for the end of the follow-up period before the results can be finalized
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If all goes well, the two companies plan to submit an application to the US FDA before the end of 2022
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Earlier this year, when regulators first began investigating cancer cases seen in Bluebird's competitor gene therapy LentiGlobin (bb1111), the prospects for CTX001 seemed even brighter
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03 Pfizer/Sarepta/Solid's DMD gene therapy The development of gene therapy for Duchenne muscular dystrophy (DMD) is underway in a three-company competition.
It may enter the final stage in 2022, but in the end it is still full of which one can win Unknown
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Pfizer was the first company to include its fordadistrogene movaparvovec (PF-06939926) drug candidate in the phase 3 trial, but after reporting 3 cases of muscle weakness (including inflammation of the heart tissue or myocarditis), the company was forced to tighten Recruitment criteria
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At the same time, Sarepta is conducting the EMBARK Phase 3 trial of the candidate drug SRP-9001, which began in October
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The company is waiting for the second data result of its mid-term study, which missed the primary endpoint when reporting the first phase earlier this year
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Solid's other gene therapy competition therapy SGT-001 is slightly behind the two competitors mentioned above
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Solid produced disappointing mid-term results in this year's Phase 1/2 study
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The study was postponed in 2019, when the FDA conducted clinical trials due to liver and platelet side effects
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04 Novartis's osteoarthritis drug LNA043 Novartis is currently conducting a phase 2b trial of a new drug, angiopoietin-like 3 (ANGPTL3) agonist LNA043
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If successful, the drug may become the first drug therapy to treat osteoarthritis to solve the potential cartilage damage that occurs in the disease.
The drug was granted Fast Track designation by the US FDA in September this year
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The Phase 2b trial involves 550 patients who will be randomly assigned to one of four KLNA043 doses or a placebo
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Novartis expects to produce the first test results before the end of 2022, but follow-up work will not be completed until 2024
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Another study of 138 patients is recruiting patients with moderate to severe pain caused by knee osteoarthritis.
Subjects will receive LNA043 alone, Novartis’ anti-inflammatory drug Ilaris (canakinumab), two experimental drugs or Placebo
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05 Bristol-Myers Squibb Milvexian In November, Bristol-Myers Squibb and its partner Johnson & Johnson reported Milvexian’s first proof-of-concept data.
The drug is the follow-up product of Bristol-Myers Squibb’s blockbuster anticoagulant Eliquis, which is expected to become The first oral factor XIa inhibitor on the market
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The second interim trial, AXIOMATIC-SSP, aims to study the potential of milvexian in preventing secondary stroke in patients with stroke or transient ischemic attack.
Bristol-Myers Squibb needs collective data sets from two studies to bring milvexian into the first Phase 3, and AXIOMATIC-SSP will deliver the results in the first half of 2022
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Bristol-Myers Squibb’s goal is to bring a new blood thinner to the market that can match the efficacy of drugs that target factor Xa (Eliquis and Johnson/Bayer Xarelto), and can avoid and limit bleeding caused by treatment Increased risk of side effects
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06 Novartis iccenticaftor Novartis is studying the efficacy of icenticaftor in the treatment of chronic obstructive pulmonary disease (COPD), but the results so far have been mixed
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In a proof-of-concept study, compared with placebo, icenticaftor achieved a modest improvement in baseline lung function changes measured before and after bronchodilator use.
It also improved biomarkers of inflammation and reduced sputum bacteria.
Colonization
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However, the drug failed to achieve the main goal of the study, which is to reduce lung infections, which is also a common complication of COPD
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However, Novartis is confident enough to start a Phase 2b dose range study.
The subjects have been fully enrolled.
The results of the test will be announced in the first half of next year.
The third phase is planned to be carried out in 2023
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07 GlaxoSmithKline, Pfizer and Johnson & Johnson RSV vaccines RSV can cause severe chest infections and deaths in very young and old people.
In the future, the virus may eventually be conquered by vaccine candidates from these three companies
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GlaxoSmithKline GSK3844766A/GSK3888550A and Pfizer RSVpreF are recombinant protein subunit vaccines, while the Johnson & Johnson adenovirus vaccine VAC18193 uses the same technology platform as COVID-19
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GlaxoSmithKline and Pfizer vaccines are being developed for two applications, including as a mother vaccine designed to protect infants from RSV infection in the first few months of life, and as an injection for the elderly.
Focus on the adult market
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This year, all three vaccines have achieved positive results in the main mid-term trials of stimulating RSV neutralizing antibodies, and they are all in phase 3 studies, and data is expected to be released in 2022
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08 Another area where Menarini and Radius breast cancer elacestrant will continue to compete in 2022 is a new class of breast cancer drugs.
These oral drugs are expected to replace the currently widely used injectable drugs
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Menarini and Radius recently reported the top-line data from the Phase III trial of the drug elacestrant, and are expected to submit regulatory documents in the United States and Europe next year
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The two companies plan to release a complete data set this month, and the therapy is expected to surpass competitors Roche giredestrant, Sanofi amcenestrant and AstraZeneca camizestrant
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Oral SERD can provide patients with a more friendly choice.
Researchers believe that compared with tamoxifen and other drugs, oral SERD will bring fewer side effects and more complete estrogen blockade, because the therapy can interact with estrogen.
The receptor binds and eliminates them instead of simply blocking signal transduction
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09 Merck's pulmonary hypertension drug sotatercept Merck's acquisition of Acceleron for US$11.
5 billion is one of the largest biotech M&A transactions in 2021.
It is worth noting that most of the value is related to the pulmonary arterial hypertension (PAH) drug candidate sotatercept
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A major turning point for this therapy will occur in 2022, when the STELLAR trial will produce results
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There are many drugs available for the treatment of PAH, but in contrast, sotatercept is expected to be the first therapy to solve the underlying pathological mechanism of the disease
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If sotatercept reaches the end point in the STELLAR trial, the industry predicts that its sales may reach US$2 billion or more and become the cornerstone of the PAH treatment field
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At the same time, Merck has two other sotatercept Phase III studies underway or in the planning stage, namely the ZENITH trial for patients at high risk of death due to PAH, and the HYPERION trial for newly diagnosed patients
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10 Alnylam and Novartis Cholesterol Therapy zilebesiran Alnylam and Novartis are co-developed with inclisiran, which is an RNAi treatment for lowering cholesterol twice a year.
Currently Alnylam hopes to continue to advance the development of a new RNAi drug zilebesiran
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Alnylam has started a phase 2 trial for mild to moderate hypertension (KARDIA-1).
The trial is testing the drug as a monotherapy in approximately 375 patients to see if the therapy contributes to safety Control blood pressure
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The test results will be announced at the end of 2022
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In addition, the company also plans to start a second, larger-scale Phase 2 trial (KARDIA-2) before the end of the year.
This trial will analyze the drug as a traditional antihypertensive drug in approximately 800 patients with uncontrolled hypertension.
Potential for add-on therapy
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If this newly designed hypertension therapy can be approved, evaluate Pharma expects that the drug's sales will reach US$2 billion in 2026
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