"Sujinmab" is expected to pick up the fourth indication of carglitazine breaking diabetic nephropathy
Last Update: 2020-06-19
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Immunotep, a biotech company focused on developing innovative immunotherapies for cancer and autoimmune diseases, announced that its soluble LAG-3 fusion protein, eftiagimod alpha (imp321), had achieved positive results in phase 2 clinical trials conducted in cooperation with MSDThe mid-term analysis of the first-line treatment of non-small cell lung cancer patients in part a of the trial showed that a sufficient number of patients met the pre-set remission criteriaBased on this result, the DMC allows immunotep to continue to recruit more patients to this phase 2 clinical trial< br / > Image Source: immunotep's official website < br / > eftiagimod alpha is a soluble LAG-3 fusion proteinIn a phase 2 clinical trial called tacti-002, it was used in combination with the PD-1 inhibitor keytruda (pembrolizumab) to treat different types of NSCLC patients, as well as head and neck cancer patientsIn trial a, patients in cohort 1 were NSCLC patients who had never received keytruda treatmentPatients participating in the trial did not need to consider the level of PD-L1 expressionThe results showed that the combination of eftilagimod alpha and keytruda could make 7 out of 17 patients have partial remission (41.2%), and another 6 patients have stable disease, the disease control rate reached 76.5%At present, 12 patients are still receiving treatment< br / > diabetic nephropathy! Canagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, was approved by the FDA in adult patients with diabetic nephropathy (DKD) and type 2 diabetes (T2D), according to Janssen, a Johnson & Johnson group company, Used to reduce the risk of end-stage renal disease (ESKD), renal dysfunction, cardiovascular death, and hospitalization due to heart failureAccording to the press release, cagregyne is the first approved new treatment option to delay the progression of kidney disease in T2D and DKD patients in the past 20 years, and the only approved hypoglycemic therapy that can not only treat diabetic nephropathy, but also reduce the risk of hospitalization due to heart failure in these patients< br / > caglequin is an SGLT2 inhibitorIt can help to control the blood glucose level of type 2 diabetic patients by inhibiting the function of SGLT2 expressed in renal tubules, weakening the reabsorption of glucose by kidney and increasing the excretion of glucose in urineThe hypoglycemic effect of SGLT2 inhibitor does not depend on the secretion of insulin, so it rarely leads to hypoglycemia, which has good safety< br / > FDA approval is based on the results of a randomized, double-blind, phase 3 clinical trial called credenceThis is a special clinical trial to detect the effect of SGLT2 inhibitor on renal functionA total of 4401 type 2 diabetic patients with stage 2 or 3 chronic kidney disease were treated < br / > the results of the trial showed that at a median follow-up period of 2.62 years, the risk of composite endpoints (including doubling of serum creatinine, ESKD and renal or cardiovascular death) in the caglequin group was 30% lower than that in the control group (HR: 0.70; 95% CI: 0.59-0.82, P < 0.001) At the same time, the risk of major adverse cardiovascular events (MACE) was reduced by 20% (HR: 0.80, 95% CI: 0.67-0.95, P = 0.01) < br / > good news for asthmatics! Novartis Co., Ltd announced that the compound therapy qvm149 developed by Novartis Co., Ltd has reached the main clinical end point in iridium, a three-stage clinical trial for patients with asthma with poor symptom control Qvm149 can significantly improve FEV1 and lung function of patients, which is better than another compound inhalation powder mist According to Dr vas Narasimhan, CEO of Novartis, the drug is a potential blockbuster drug that Novartis plans to launch in 2020 Detailed data on the iridium trial will be released at a future scientific conference < br / > qvm149 developed by Novartis is a once a day, fixed dose compound product, which is composed of three effective ingredients: long-acting muscarinic antagonists (glulammonium bromide), long-acting β 2 receptor agonists (indarterol) and inhaled corticosteroids (mometasone furoate) At present, the application for marketing of the treatment is under review by the European Drug Administration (EMA) < br / > in iridium, a randomized, double-blind, active control phase 3 clinical trial, 3092 adult patients with poor asthma control were randomly treated with two different doses of qvm149 or qmf149 All of these patients had been treated with medium / high stable doses of long-acting β 2-receptor agonist / corticosteroid (Laba / ICs), but the symptoms were not effectively controlled The results showed that qvm149 not only significantly improved the lung function of patients, but also improved the forced expiratory volume (FEV1) of patients in one second, reaching the main end point of the test At week 26, the qvm149 group showed improvement in asthma control in terms of asthma questionnaire score (acq-7), but failed to reach the key secondary end point of the trial < br / > target RNA! Vertex has invested $700 million to join hands with ribometrix < br / > vertex pharmaceuticals and ribometrix to jointly announce that they have reached a strategic cooperation to jointly develop new RNA targeted small molecule drugs for the treatment of serious diseases The collaboration combines ribometrix's proprietary technology platform with vertex's clinical R & D and regulatory capabilities for the development of multiple treatment options Among them, one of the most important projects is to develop small molecule drugs for the treatment of Huntington's disease (hd) < br / > ribometrix's RNA probe technology can help identify RNA structural areas that may be suitable for drug binding, and use a proprietary technology platform to target RNA molecules folded into complex three-dimensional structures to generate structural "pockets" suitable for small molecule ligand targeting Compared with the existing drugs targeting RNA, this method has higher selectivity and drug efficacy In addition, the oral bioavailability of the drug and the permeability of the central nervous system were improved < br / > Image Source: ribometrix official website < br / > according to the terms of the agreement, vertex will pay about $20 million in advance to ribometrix, including the equity investment in the company After successful drug development, ribometrix is likely to receive more than $700 million in potential milestone payments In addition, vertex will pay the corresponding sales share of ribometrix for the future global net sales revenue of the drugs developed in this cooperation < br / > bacterial pneumonia or "killer"! MSD announced that its innovative antibiotic combination recarbrio reached the primary and secondary end points of the trial in the phase 3 key restore-imi for the treatment of hospital acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (habp / vabp) < br / > the innovative antibiotic combination recarbrio is composed of a fixed dose of relebactam and imipenem / cilastatin Among them, relebactam is a diazabicyclooctane β - lactamase inhibitor with broad-spectrum anti β - lactamase activity Although β - lactamase inhibitor has no antibiotic activity, it can enhance the activity of β - lactamase antibiotics Imipenem / cilastatin is a common compound preparation in clinic The purpose of the < br / > restore-imi trial was to verify the efficacy and safety of recarbrio in the treatment of habp / vabp The results showed that on the 28th day, compared with piperacillin / tazobactam (piperacillin / tazobactam), recarbrio achieved statistical non inferiority in all-cause mortality and clinical remission indexes, i.e the primary and secondary endpoints of the trial The incidence of adverse events observed in the trial was similar in both groups MSD plans to present all the data at a scientific conference in 2020 < br / > fight again DMD! Nippon shinyaku announced that it has submitted a new drug application (NDA) of its targeted RNA innovative therapy viltolarsen (ns-065 / ncnp-01) to the US FDA for the treatment of Duchenne muscular dystrophy (DMD) patients with specific dystrophin gene mutation At the end of last month, Nippon shinyaku company had submitted the regulatory application of viltolarsen in Japan If approved, viltolarsen is expected to become the second non hormonal drug for specific DMD patients Viltolarsen, developed by Nippon shinyaku company, is a kind of oligonucleotide drug with morpholine substituted phosphoryl diamide It targets the splicing process of the anti atrophic protein mRNA precursor, aiming to introduce exon 53 jumping to generate the truncated but still functional anti atrophic protein According to statistics, about 10% of DMD patients carry mutations suitable for exon 53 jumping therapy Previously, the FDA has granted viltolasen rare pediatric disease design, orphan drug design, and fast track design It also won the sakigake design and orphan drug qualification issued by the Ministry of health, labor and welfare of Japan in 2015 < br / > The results showed that compared with the untreated patients in the natural history control group, the time taken by the patients treated with viltolarsen to walk 10 meters, walk 6 minutes, and rise from sitting posture were improved In the previous experiment, viltolarsen also reached the biological end points of dystrophin expression and muscle strength increase < br / > the fourth indication? "Sukingumab" reached the phase 3 clinical end point < br / > Novartis announced that its first approved all human anti-il-17a monoclonal antibody, cosentityx (secukinumab, scuchiumab, commonly known as "sukingumab"), reached another main end point in the phase 3 clinical trial for the treatment of non radioactive axial arthritis (NR axspa) At 52 weeks of treatment, the proportion of patients who met the criteria of asas40 was significantly higher than that of the control group Last month, Novartis just announced that cosentix reached the 16 week primary and all secondary endpoints in this trial The latest data announced further proves the long-term efficacy and safety of cosentyx in the treatment of ankylosing spondylitis (as), psoriatic arthritis (PSA), and psoriasis Novartis expects to submit regulatory applications to the FDA later this year If approved, this would be the fourth indication for cosentyx Novartis has previously submitted an application for the indication to the European Drug Administration (EMA) < br / > cosentyx is the first all human biological agent that can directly inhibit IL-17A IL-17A (IL-17A) is a key pathogenic factor in the pathogenesis of PSA, as and psoriasis Cosentyx can specifically bind to IL-17A from any source without interfering with the normal work of other cytokines Because of the precise target and the higher safety brought by the whole human antibody, the drug has a fast and lasting efficacy and safety in the treatment of inflammatory diseases At present, cosentix has been approved to treat PSA, as and psoriasis, and to treat other inflammatory diseases in clinical trials < br / > 555 NR axspa adult patients participated in this 2-year randomized, double-blind, placebo-controlled phase 3 clinical study The purpose of this study is to assess cosentyx
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