January 8, 2019
Bioscience Notebook

FDA green lights Arvinas' prostate cancer trials; Biohaven migraine drug trials a go in China

Photo | Contributed
Photo | Contributed
Arvinas CEO John Houston
Photo | Contributed
New Achillion Board Chair Nicole Vitullo

New Haven biotech Arvinas Inc. is advancing its first cancer drug into the clinic after getting the green light from federal regulators.

Arvinas said Friday the U.S. Food & Drug Administration has cleared its investigational new drug application (IND) for ARV-100 to treat metastatic castration-resistant prostate cancer.

Arvinas is developing a new class of drugs that destroy disease-causing cellular proteins, part of an emerging field in the pharmaceutical industry known as protein degradation.

The company will commence a Phase 1 clinical trial in the next three months to study the safety and tolerability of the drug, which uses PROTAC technology developed at Yale.

PROTACs (short for proteolysis-targeting chimeras) are small molecules that induce the body's own cells to attack and remove the troublesome proteins.

CEO John Houston called the decision "a key step forward" for the company, which went public this past September and sealed a major licensing deal with Pfizer last January.

"Our PROTAC platform has demonstrated exciting promise in preclinical studies and represents an entirely new approach to treating patients with mCRPC and many other diseases," he said.

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Biohaven Pharmaceutical Holding Co. Ltd. said it will commence clinical trials of its cutting-edge migraine drug in China this year after receiving the go-ahead from the Chinese equivalent of the FDA.

Biohaven and its newly launched Shanghai-based subsidiary BioShin said Monday that China's National Medical Products Administration had accepted the company's investigational new drug application (IND) for rimegepant.

Part of a new class of drugs known as calcitonin gene-related peptide (CGRP) receptor antagonists, rimegepant works by blocking a brain chemical that transmits pain.

It is billed as an alternative for migraine sufferers with heart conditions, who are unable to take widely used migraine drugs known as triptans because they constrict blood vessels.

Biohaven has already conducted three Phase 3 trials on the drug in the U.S. with positive results. The company expects to file for FDA approval for the drug here later this year.

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Achillion Pharmaceuticals' Board of Directors has elected Nicole Vitullo, partner at a health care-focused private equity firm, as its new chair.

Vitullo, a partner at Domain Associates LLC, replaces David Scheer, an Achillion board member for more than two decades and chair since 2010. He will remain on the board.

Scheer called Vitullo "an excellent choice," citing her "successful track record and experience advising and helping grow public health-care companies."

An Achillion director since 2010, Vitullo also serves on the boards of Celtaxsys, Esperion Therapeutics, Marinus Pharmaceuticals and Antios Therapeutics.

Achillion is developing drugs to treat rare, immune-related diseases by inhibiting an immune system enzyme known as Factor D.

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New Haven-based BioXcel Therapeutics Inc. has appointed Robert Risinger, MD, as vice president for clinical development, just as its first neuro drug heads into clinical trials.

A pharmaceutical industry veteran who specializes in neuropsychiatric drug development, Risinger will spearhead the development of BXCL501, an under-the-tongue film version of an older IV drug dexmedetomidine (Dex).

BioXcel is studying the drug for the treatment of acute agitation in patients with Alzheimer's disease, schizophrenia and bipolar disorder. The FDA has awarded it "fast track" status, a designation that could accelerate the federal review process.

Risinger's résumé includes stints at Bristol-Myers Squibb, Johnson & Johnson, Alkermes and most recently NeuroRx Pharmaceuticals. His hiring brings the company's total headcount to nearly 20, BioXcel said.

Contact Natalie Missakian at news@newhavenbiz.com

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