Bristol-Myers Squibb reports positive data for Zeposia

Bristol-Myers Squibb (BMY) announced detailed data from its pivotal Phase 3 trial True North. The company stated that the trial met both of its primary endpoints. It also fulfilled its key secondary objectives. Further, the data showed that its overall safety profile was in line with the previously observed safety profile for Zeposia and patients with moderate to severe ulcerative colitis.

The primary endpoints of the trial pertained to clinical remission compared to placebo at induction at Week 10 and in maintenance at Week 52. The drug candidate met both the conditions with high statistical significance and clinically meaningful results. Mary Beth Harler of Bristol-Myers Squibb said, “These Zeposia True North results represent a meaningful achievement for patients living with ulcerative colitis, many of whom have an inadequate response or do not respond at all to currently available therapies.” The company will now work towards commercializing Zeposia for ulcerative colitis.

18.4 percent of the patients in the treatment group showed clinical remission at induction at Week 10, in comparison to 6 percent of the placebo group patients achieving the same. The clinical remission in maintenance at Week 52 stood at 37 percent while for placebo, the ratio was at 18.5 percent.

The key secondary endpoints for the trial involved endoscopic improvement, mucosal healing and clinical response in induction at Week 10 and in maintenance at Week 52. 47.8 percent of patients in the Zeposia cohort achieved clinical response at Week 10, the corresponding percentage in the placebo cohort was 25.9 percent. At Week 52, the percentages with 60 percent and 41 percent, respectively. The data from sub-analyses showed consistent results.

The drug candidate also showed benefits on endoscopic and histologic fronts, which are generally difficult to achieve. This finding underscores the potential of the drug candidate to emerge as an effective and safe treatment option for the condition.

The key secondary endpoints were found to be highly statistically significant at Week 10. In patients with previous TNF-inhibitor exposure, Zeposia was able to show better results but those were not statistically significant at Week 10. Even for clinical response, the statistically significant difference was nominal.

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For Maintenance Period at Week 52, patients in Zeposia cohort showed statistically significant results for maintenance of remission, durable remission, mucosal healing, corticosteroid-free remission, clinical response and endoscopic improvement. Zeposia also improved clinical remission and response irrespective of previous TNF-inhibitor use at Week 52.

True North trial enrolled 645 patients in the induction phase. These patients were randomized and were administered Zeposia or placebo.

Analysis: The ulcerative colitis (UC) market was $6.79 billion in 2018 and is expected to reach $10.25 billion by 2027 at a CAGR of 4.6%. It is estimated that worldwide ~12.6 million people have this chronic inflammatory bowel disease (IBD). There is no known cure. Treatment only serves to alleviate symptoms and some long-term remission. Major treatment options are – Anti-inflammatory 5-aminosalicylates like sulfasalazine (Azulfidine), mesalamine (Asacol HD, Delzicol, others), balsalazide (Colazal) and olsalazine (Dipentum); Corticosteroids like prednisone and budesonide, given short term only due to side effects; Immunosuppressants like Azathioprine (Azasan, Imuran) and mercaptopurine (Purinethol, Purixan), Cyclosporine (Gengraf, Neoral, Sandimmune), Tofacitinib (Xeljanz); Biologics like Infliximab (Remicade), adalimumab (Humira), golimumab (Simponi), Vedolizumab (Entyvio), and Ustekinumab (Stelara). Surgery may also be considered as a last resort.

Investment Thesis: A premium stock with impressive dividend payments has long been an income investment portfolio favorite. It continues to boost its position with strong development pipeline and robust product portfolio.

Alkermes receives favorable FDA advisory board response for ALKS 3831

Alkermes plc (ALKS) reported that the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee have passed a favorable verdict for ALKS 3831 in their joint meeting. The committees decided that samidorphan meaningfully mitigates olanzapine-associated weight gain. The meeting also concluded that the drug candidate’s safety profile has been adequately characterized.

While the joint advisory committee’s recommendations are not binding on FDA, the regulatory agency takes due cognizance of the advisory while reviewing the New Drug Application for the drug candidate. Craig Hopkinson of Alkermes said, “The ALKS 3831 development program is part of our ongoing commitment to develop new therapeutic options for adults living with serious mental illness. Today’s outcome marks an important step for this program and we look forward to working with the FDA as it completes its review of the ALKS 3831 New Drug Application.”

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The Prescription Drug User Fee Act (PDUFA) target action date for the ALKS 3831 NDA has been set at November 15, 2020. The committee jointly voted that labeling for the drug candidate is adequate to mitigate the risks related to the opioid antagonist action of samidorphan. Alkermes proposes to begin a comprehensive education plan for the drug candidate, which will include information for potential pharmacists and prescribers.

ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate. It is designed to treat adult patients with schizophrenia and bipolar I disorder. It is made of samidorphan co-formulated with olanzapine, in a single bilayer tablet. Samidorphan is a novel, new molecular entity while olanzapine is an established antipsychotic agent.

Alkermes plc is a fully integrated, global biopharmaceutical company. It has strong portfolio of proprietary commercial products dealing with addiction and schizophrenia.

Investment Thesis: The stock is trading at a considerable discount after shaky performance in the past. However, it may provide a robust return on the upcoming catalyst in November.

Seagen reports positive data from Phase 2 PADCEV study

Seagen Inc. (SGEN) announced positive topline data from the second cohort of patients from the EV-201 study. The cohort assessed the antibody drug conjugate PADCEV for patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor, fulfilling additional requirements.

The data showed a 52 percent objective response rate per blinded independent central review. The median duration of response was 10.9 months. PADCEV was given accelerated approval by the FDA in 2019. Roger Dansey, M.D., Chief Medical Officer at Seagen, said, “This is the first trial to report objective responses in patients with advanced urothelial cancer who had previously received immunotherapy but were ineligible for cisplatin in this setting due to inadequate kidney function or other conditions.” The company plans to use the data for filing its regulatory application for the expanded use of PADCEV.

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The EV-201 trial is a single-arm, pivotal phase 2 clinical study. The trial enrolled 128 patients in cohort 1 and 91 patients in cohort 2. The primary endpoint of the trial pertained to confirmed objective response rate per blinded independent central review. Secondary endpoint of the trial was related to the evaluation of duration of response, disease control rate, progression-free survival, overall survival, safety and tolerability.

PADCEV is a first-in-class antibody-drug conjugate targeting Nectin-4, a protein located on the surface of cells. This protein has been found to be highly expressed in bladder cancer. PADCEV works by binding to Nectin-4 expressing cells. Seagen collaborates with Astellas Pharma Inc. for developing this drug candidate.

Investment Thesis: while the company has positive prospects ahead, its recent runup makes the valuation on the higher side. Any decent pullback may provide the opportunity to build up a position.

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Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.