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Daily Brief: Summit's $12m lifeline, Biohaven's speech anxiety pill, Crescendo's Humabody progress

News from pharma, biotech and healthcare

Summit gets $12m lifeline for C diff drug

UK specialist pharma company Summit Therapeutics has been awarded an extra $12m from a US government department to fund development of a new antibiotic.

The additional funds are very welcome news after the firm suffered a major disappointment when its Duchenne drug failed in phase II trials in June.

Following this setback, the company will have to make job losses, but believes its novel mechanism antibiotics will provide it with a long-term sustainable business.

The Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services is giving the funds to support phase III development of ridinilazole, Summit’s precision new mechanism antibiotic for the treatment of C. difficile infection (‘CDI’).

Summit’s chief executive Glyn Edwards welcomed the funding and said the phase III trials were on track to commence in the first quarter of 2019.

Nervous about that big presentation? Biohaven might have a pill for that

Biohaven has unveiled early results for its candidate BHV-0223 which it believes could be prescribed to people suffering ‘social anxiety disorder’ and ‘public speaking anxiety’.

The US specialist pharma company has acquired rights to a wide-range of neurology candidates from other companies, aiming to bring them to market in niche setttings.

BHV-0223 is a sublingual formulation of riluzole, a drug already used against the muscle degenerative disease amyotrophic lateral sclerosis.

The investigator-initiated trial was performed at Yale University School of Medicine and treated 21 subjects who had a diagnosis of social anxiety disorder and participated in an anxiety-provoking, speech task in a double-blind, crossover design.

In the pre-specified, primary analysis, BHV-0223 reduced anxiety by 8.3 points relative to placebo on the 100-point Visual Analogue Scale (VAS), as well as other measures. In addition, BHV-0223 was safe and well-tolerated during this study.

The company believes the drug could replace the use of older drugs used in such situations, and which have undesirable side-effects.

Vlad Coric

Biohaven CEO Vlad Coric

"Approximately 20% of Americans have experienced an anxiety disorder in the past year but many current treatments are encumbered by side effects including sedation, cognitive impairment and potential for addiction," said Vlad Coric M.D., CEO of Biohaven.

"By combining anxiolytic properties and a favorable safety profile, we believe that glutamate modulating agents may offer patients who are not satisfied with existing therapies a novel treatment option."

Biohaven has licensed riluzole from Yale University, and has a pipeline of prodrugs of riluzole designed for optimised safety, tolerability and pharmacokinetics. These include troriluzole (BHV-4157), currently in late-stage clinical trials in spinocerebellar ataxia (SCA), obsessive compulsive disorder (OCD), and Alzheimer's disease (AD).  The company expect to  submit a New Drug Application (NDA) for BHV-0223 for the treatment of amyotrophic lateral sclerosis (ALS) to the FDA in the third quarter of 2018.

Crescendo reaches milestone in Humabody development

Building on a $790m-worth collaborative deal with Japanese pharma giant Takeda, Crescendo has reached another technical milestone with its Humabody platform.

The Cambridge, UK-based biotech says the new development marks a successful delivery of a “highly diverse panel” of functional Humabody leads against Takeda’s selected targets.

The company is one of a number of biotechs looking to develop the next generation of biologics against cancer, aiming to reach targets on tumours currently inaccessible to conventional monoclonal antibodies.

Humabody products are a novel class of extremely small protein therapies based on fully human Vh domain building blocks.

Compared to full antibodies, Humabodies have differentiated pharmacological properties and can rapidly penetrate and accumulate in tumours.

Peter Pack

Crescendo's Peter Pack

Dr Peter Pack, CEO of Crescendo, commented: “Crescendo has once again demonstrated its ability to deliver, ahead of schedule, a diverse selection of functional Humabody molecules meeting the stringent specifications outlined in the collaboration agreement.

“Our highly productive relationship draws together Takeda’s deep oncology experience with Crescendo’s expertise in developing optimally configured Humabodies. Together we are fast progressing towards our goal of developing next generation, highly modular and multi-functional biologics against cancer.

The technical milestone also brings with an undisclosed financial milestone payment for the company.

Article by
Andrew McConaghie

16th August 2018

From: Research

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