Pharma Product News
October – 21st October
Karuna Pharmaceuticals has started its Phase two trial of KarXT, a drug being developed for the treatment of Schizophrenia
Karuna Pharmaceuticals is an affiliate of UK Biotech firm PureTech Health. KarXT consists of xanomeline a receptor with proven efficacy in placebo-controlled human trials in Schizoprenia and Alzheimers disease and trospium chloride an FDA approved receptor antagonist that has been shown not to enter the central nervous system. In the first phase study, KarXT successfully demonstrated tolerability at a dose level exceeding those shown to be efficacious in previous studies of xanomeline alone. Data from this study supported the dosage selection to be used in the second trial, which has the aims of reproducing efficacy results previously observed in a schizophrenia trial with xanomeline monotherapy. If this treatment were to succeed in passing clinical trials Karunas chief executive Steve Paul said that the treatment “could be effective in treating not only positive symptoms but also the disabling negative and cognitive symptoms of the disease.”
Wednesday 17th October
NHS greenlight Novartis skin care combo
The NHS has three months to ensure that Novartis skincare combination therapy dabrafenib/trametinib is available to skin cancer patients. NICE has recommended this combination for patients with stage III BRAF V600 mutation-positive melanoma, whose disease has spread to their lymph nodes or their lymph glands and who have had surgery to remove the tumour and associated lymph glands. This patient group have never had any other treatments with only surgery and radiotherapy available in certain cases. The aim of Novartis’ adjuvant therapy is to remove any residual cancer left behind to prevent recurrence. Clinical trials have shown that patients taking dabrafenib plus trametinib had higher rates of relapse-free survival (88% at 1 year, 67% at 2 years, and 58% at 3 years) compared with patients taking the placebo (56% at 1 year, 44% at 2 years, and 39% at 3 years). This provides a huge step forward for patients who have very few options left following surgery.
Friday 19th October
NICE rejects Eli Lilly’s breast cancer drug Verzenios
Eli Lilly’s cancer drug will not be funded by the NHS, after cost regulators released draft guidelines rejecting the drug. NICE states that Verzenios is just as effective as the current treatment being used, but when the patient access schemes are considered Verzenios is not as cost effective as the others being currently used. Verzenios was approved in Europe for the treatment of certain metastatic breast cancers earlier this month, based on data from the Phase 111 MONARCH 2 and 3 trials.
In MONARCH 2, Verzenios combined with AstraZeneca’s Faslodex, was found to considerably progression free survival compared to Faslodex on its own, with figures of 16.4 months versus 9.3 months respectively.