NanoViricides Inc., a Shelton company which is developing nanomedicines to target viruses, announced on Monday that its first drug candidate for treating shingles, NV-HHV-101, is making progress toward human clinical trials.
Shingles is caused by the same virus that causes chickenpox, and patients experience a painful, spreading rash with blisters.
According to the company, NV-HHV-101 has been found to be “safe and well tolerated” as a dermal treatment in a clinical observation portion of a safety and toxicology study. NanoViricides is still waiting for histology studies to determine whether the drug candidate has any adverse effects on organs.
Researchers used the substance on minipigs, which received a skin treatment twice a day for 28 days. The animals were then evaluated for any signs of toxicity, and researchers determined the treatment was well tolerated, according to the company.
Both NanoViricides and an outside contract research organization, BASi of Indiana, reached the conclusion that NV-HHV-101 was “safe and well tolerated,” the press release said. More studies of its safety are ongoing. If these studies are successful, NanoViricides plans to advance NV-HHV-101 into human clinical trials for topical dermal treatment of the shingles rash.
NanoViricides is also pursuing topical treatments for cold sores and genital ulcers.
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Arvinas Inc., a New Haven-based biotechnology company, reported increased revenue for the quarter ending June 30, but a higher net loss compared to the same period last year.
The company is developing a new class of drugs aimed at degrading disease-causing proteins. Early this year, it began a Phase 1 clinical trial for ARV-110, which aims to treat patients with metastatic castration-resistant prostate cancer.
As of June 30, the company’s cash, cash equivalents and marketable securities were at $159.2 million as compared to $187.8 million as of December 31, 2018, a decrease of $26 million, according to a press release. These figures don’t include proceeds from a July agreement with Bayer which is expected to provide an additional $51.5 million.
Company officials attributed the decrease to cash used for operating activities, the purchase of lab equipment and leasehold improvements.
Arvinas’ revenue was at $4 million for the quarter ending June 30, compared to $3.4 million for the same period in 2018.
The company reported its net loss at $17.2 million for the quarter, as compared to $7.9 million for Q2 in 2018. Company officials attributed the higher net loss to increased research and development, and general and administrative expenses.
The company spent more for research and development: $16 million in Q2 2019 compared to $10 million for Q2 2018, primarily related to expenses for the ARV-110 clinical trial and increased personnel.
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Biohaven Pharmaceutical Holding Company Ltd. of New Haven has enrolled its first patient in a Phase 3 clinical trial to determine if verdiperstat is safe and effective for treating patients with Multiple System Atrophy (MSA), a rare and fatal neurodegenerative disease.
Patients have problems with movement similar to those suffering from Parkinson’s disease, including tremor, poor balance and cerebellar ataxia.
The U.S. Food & Drug Administration’s Office of Orphan Products Development has given verdiperstat orphan drug designation for the treatment of MSA.
Irfan Qureshi, MD, Biohaven’s vice president and development lead for verdiperstat, said, “Verdiperstat is the first product candidate from Biohaven’s neuroinflammation platform and highlights our commitment to developing innovative medicines for neurological diseases with high unmet need.”
Biohaven expects to recruit approximately 250 MSA patients across the U.S. and Europe for its study. Researchers will evaluate verdiperstat’s effectiveness against a placebo.
Jeremy D. Schmahmann
Jeremy D. Schmahmann, MD, professor of neurology at Harvard Medical School and founding director of the Massachusetts General Hospital Ataxia Unit, said in a statement, “We are excited to have enrolled the first patient in this study. Working together with our patients and the Biohaven team, we are optimistic that this is the beginning of a new era of treatment and eventual cure for this challenging neurodegenerative disorder.”
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Cara Therapeutics of Stamford has announced the closing of its public offering of over 6 million shares of its common stock, offered at $23 per share. The gross proceeds from the offering were about $145.5 million, according to the company. It plans to use the proceeds toward its efforts to advance its drug Korsuva for the treatment of pruritus, or chronic itchy skin, associated with chronic kidney disease, liver disease and atopic dermatitis.
