3 Things In Biotech, May 7: Novartis Thyroid Breakout, Redhill's Stomach Bugs, Intra-Cellular Update On Schizoid Drugs

Includes: ITCI, NVS, RDHL
by: Zach Hartman

Novartis scores a new approval for their MEK combo in thyroid cancer.

Redhill digs into stomach bugs.

Intra-Cellular to divulge new schizophrenia data.

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Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.

Novartis scores a new approval for their MEK combo in thyroid cancer

Company: Novartis (NVS)

Therapy: Dabrafenib and trametinib

Disease: Thyroid cancer

News: The FDA announced that they have granted approval for the use of the Raf/MEK inhibitors dabrafenib and trametinib for the treatment of anaplastic thyroid cancer that is unresectable or metastatic. This approval requires that the tumor test positive for a BRAF mutation. This marks the third tumor type approved for this drug combination, after melanoma and non-small cell lung cancer.

Looking forward: I don't follow the Raf/MEK inhibitor field incredibly closely, so this news took me by surprise. I had not personally realized that the FDA was reviewing this application for approval, so this is interesting news! It's also welcome, as across thyroid cancers there is a dearth of effective treatment options, and in particular this form of the disease has a notably poor prognosis and rapid course.

Good news for the continuing buildup of the dabrafenib/trametinib force.

Redhill digs into stomach bugs

Company: Redhill Biopharma (RDHL)

Therapy: RHB-105

Disease: Helicobacter pylori infection

News: RDHL announced that they have enrolled almost three quarters of the 444 patients they are targeting in the phase 3 ERADICATE Hp2 study, which is assessing the use of the combo drug RHB-105 for the treatment of Helicobacter pylori infection. This study is intended to confirm the findings from ERADICATE Hp, which showed superiority for the drug over historical controls.

Looking forward: H. pylori remains an important cause of stomach cancer, particularly outside the United States. In all, some 50% of the world's population is infected with this bacterium, so it is important for us to develop new tools to help combat it. In the case of RDHL's product, it is the combination of 2 different antibiotics, in addition to a proton pump inhibitor, tackling the infection and the complications of the infection at the same time. Hopefully, this enrollment news signals rapid progress for the trial, and perhaps a regulatory filing in early 2019.

Intra-Cellular to divulge new schizophrenia data

Company: Intra-Cellular Therapies (ITCI)

Therapy: Lumateperone

Disease: Schizophrenia

News: ITCI announced that they will present an update to their open-label safety switching study investigating lumateperone in patients with schizophrenia at the 2018 APA Annual Meeting. In the press release, the company divulged that they observed significant improvements in body weight and lab findings compared with baseline upon switching to lumateperone, which worsened when switching back to standard-of-care antipsychotics.

Looking forward: This is a favorable look at rather early data that helps to bolster the exploration of this agent. Certainly, it is not enough on its own to get approval, but the mental disorders are notoriously challenging treatment areas, so I'll take whatever I can get when it comes to these diseases.

This may signal an important up-and-comer in the mental health space.

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