Bristol Myers’ psoriasis drug; GW Pharmaceuticals eyes US market for Nabiximols; Karyopharm’s Xpovio; Kiadis USD 358M Buyout

Posted on Nov 4, 2020 by Delveinsight

pharma happenings for BMS Sanofi GW Pharmaceuticals Kiadis

Bristol Myers’ Experimental Psoriasis drug succeeds in late-stage study defeats rival Amgen’s Otezla

Bristol Myers’ experimental psoriasis drug, deucravacitinib has outmarched Amgen’s Otezla (apremilast) in the POETYK PSO-1 Phase III clinical trial in patients with moderate to severe plaque psoriasis. Deucravacitinib (BMS-986165) is the first and only novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor in clinical trials across several immune-mediated diseases, involved in the mediation of the signaling of cytokines IL-23, IL-12, and Type I IFN. 

The trial POETYK PSO-1 is the first of two global Phase III trials investigating the drug compared to placebo and Otezla in moderate to severe plaque psoriasis. A total of 666 patients diagnosed with moderate to severe plaque psoriasis were enrolled in the randomized study, to receive deucravacitinib, a placebo, or Otezla. 

The study showcased the efficiency of the drug in improving symptom severity, and the company believes by inhibiting TYK2, outcomes in a range of diseases including psoriasis, lupus, and inflammatory bowel disease can be improved. 

GW Pharmaceuticals launches Phase III trial of Nabiximols (Sativex) for Multiple Sclerosis 

Nabiximols, known as Sativex outside the US, is approved to treat MS spasticity in over 25 countries. It is a complex botanical oral spray formulated from the cannabis plant. Its principal components cannabinoids are THC and CBD, along with other cannabinoid and non-cannabinoid plant components in minor amounts.                                                                                                                                                                     

The results from previous Phase European studies demonstrated well-tolerance of the medicine with continued reduction in patient-reported spasticity for individuals with MS. It is already approved in several European countries; however, in hopes of launching its therapy in the US Medical Marijuana market, the company launched a Phase III trial in America. 

GW Pharmaceuticals already owns one approved therapy, Epidiolex, in the US for the treatment of seizures associated with two rare forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome. If Nabiximols gets approved, it will be the second cannabis-based product of the company in the US. 

Karyopharm Therapeutics hopes to launch Xpovio for another Solid Tumor

Karyopharm Therapeutics announced positive top-line results from the Phase 3 portion of the randomized, double-blind, placebo-controlled, cross-over, SEAL study. The trial investigated a single agent, oral Xpovio (selinexor) versus matching placebo in patients with advanced unresectable dedifferentiated liposarcoma

The SEAL study met its primary endpoint of a statistically significant increase in progression-free survival (PFS), with reduced risk of disease progression or death by approximately 30%, compared to placebo.  The safety profile for XPOVIO was consistent with previous clinical studies.

Xpovio, a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound, has already been approved for patients with relapsed or refractory multiple myeloma and relapsed or refractory DLBCL. Karyopharm has submitted a supplemental New Drug Application (sNDA) for Xpovio for expanded approval to include it as a treatment for patients with multiple myeloma after at least one prior line of therapy with an action date by the FDA of March 19, 2021.

Sanofi, in a USD 358M Kiadis buyout, acquires a Natural Killer Cell Platform 

Sanofi has announced the acquisition of a Netherlands-based biotech Kiadis Pharma for USD 358 Million or 308 million euros. The transaction is expected to close during the first half of 2021.

Sanofi earlier had in-licensed Kiadis’ K-NK004, which it intends to investigate with its recently approved CD38-directed antibody, Sarclisa (isatuximab-irfc) for multiple myeloma. The acquisition now allows Sanofi to take possession of the rest of the Kiadis pipeline.

Further, Sanofi will add Kiadis’ three experimental therapies to its portfolio for different types of cancers. The acquisition depicts the determination of Sanofi to deal with the burden Cancer poses on healthcare. While for Kiadis, the deal will solve the problem of funds. 

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