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February 11, 2020 Bioscience Notebook 

Biohaven scraps anxiety treatment after failed trial; Arvinas expands again at Science Park 

PHOTO | CONTRIBUTED Biohaven CEO Vlad Coric
By Natalie Missakian

Biohaven Pharmaceuticals has pulled the plug on developing its experimental drug for anxiety after the compound performed poorly in a clinical trial.

The New Haven neuro drug developer  — best known for its new migraine treatment awaiting FDA approval — said Monday that another drug in its pipeline, troriluzole, failed to beat a placebo in a Phase 3 trial to treat generalized anxiety disorder. Phase 3 is the final stage of human trials before drug approval.

Roughly 400 patients who took the drug for eight weeks improved an average of 9.28 points on an anxiety rating scale, about the same as those who took the placebo, Biohaven reported.

Biohaven’s stock fell 8.2 percent to $47.06 Monday on the news. 

“While these efficacy results were disappointing and do not support continued development of troriluzole as a monotherapy in GAD, we have multiple ongoing studies in other disease indications with different dosing paradigms,” CEO Vlad Coric, MD, said in a statement. 

A reformulation of an older drug for amyotrophic lateral sclerosis (ALS), troriluzole regulates the brain chemical glutamate, thought to play a role in multiple neurological and psychiatric diseases. 

Biohaven has also been testing the drug to treat symptoms of Alzheimer’s disease, obsessive compulsive disorder and spinocerebellar ataxia, which affects movement.

Troriluzole passed a“futility analysis” for Alzheimer’s late last year, raising hopes for success in that indication. Results from that trial are expected before the end of the year; results for the OCD trial are expected by the end of June. 

Meanwhile, Biohaven is continuing to ramp up for the anticipated commercial launch of its first drug, rimegepant, a new oral treatment for migraine attacks. FDA approval for that drug is expected by the end of March.

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Growing New Haven biotech Arvinas Inc. is again expanding its footprint at Science Park.

The biopharmaceutical company, which last year launched its first clinical trials on drugs for breast and prostate cancer, has added 10,000 square feet to its leased space, according to a Feb. 6 U.S. Securities and Exchange Commission filing.

A spokesman told New Haven Biz Monday that the company needed additional lab and office space to accommodate its rapid growth. Arvinas added 60 employees in 2019 and expects a similar hiring spree this year, with plans to increase its headcount from 140 to 200 by year’s end, the spokesman said.

The latest addition follows a previous expansion in 2018. It brings Arvinas’ total square footage to 49,000, from about 9,500 when it first became a tenant in 2013. 

Arvinas’ cancer drugs use a protein-degrader technology called PROTACs, created by founder and Yale scientist Craig Crews. PROTACs (short for proteolysis-targeting chimeras) induce the body’s own waste-removal system to eliminate troublesome proteins that cause disease. 

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The FDA last week gave its blessing to two New Haven biotechnology companies seeking to launch human trials on drugs targeting multiple myeloma and opioid withdrawal.

The federal regulatory agency greenlighted the Investigational New Drug (IND) applications for fledgling oncology startup Kleo Pharmaceuticals Inc. and artificial intelligence biotech BioXcel Therapeutics Inc., clearing the way for both to proceed with their respective trials.

Kleo said last week it will test its multiple myeloma compound KP1237 in 25 to 30 patients who have undergone bone marrow transplantation as a treatment for the disease, which afflicts around 30,000 people a year in the U.S.   

The trial — the four-year-old startup’s first — is expected to begin enrolling patients in the second half of this year; results are expected in mid-to-late 2021. 

Based on Yale professor of chemistry David Spiegel’s research, the drug is a “cell homing” molecule that induces the body’s natural killer cells to recognize and destroy cancer cells. Kleo said animal studies showed fewer toxic side effects than existing treatments.

BioXcel said it will begin a Phase1b/2 trial to test the safety, tolerability and efficacy of its an anti-agitation drug BXCL501 in patients who are physically dependent on opioids.

Patients will be given either the drug or a placebo twice daily for five days and monitored for withdrawal symptoms over a 10-day period, BioXcel said. 

The drug is a thin-film formulation of an older drug, known as “Dex” (dexmedetomidine), which was previously used in surgical suites as an anesthetic. 

BioXcel’s version tastes minty and dissolves under the tongue, similar to a mouthwash strip. The company touts it as less invasive than tranquilizer injections for calming agitated patients. 

Opioid withdrawal is the company’s fourth possible indication for BXCL501. Trials studying the drug for agitation in schizophrenia, bipolar disorder and dementia are underway.

BioXcel said the non-opioid treatment reduces physical withdrawal symptoms by decreasing excessive neuronal firing. 

Natalie Missakian can be reached at news@newhavenbiz.com.

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