InnovationRx: Positive Clinical Trial Results For Generative AI-Designed Drug

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Insilico Medicine announced results from a clinical trial of ISM001-055, which the company designed using generative AI in order to treat idiopathic pulmonary fibrosis, a chronic lung disease affecting around 100,000 Americans that makes breathing increasingly difficult as it progresses.

The phase IIa study, conducted in China, involved 71 patients who were randomized to either receive a placebo, a daily 30mg pill, a twice-daily dose of a 30mg pill, or a daily 60 mg pill. Across all patients, the majority of side effects were mild or moderate, the company said. Those who received the highest dose law improvement in lung function compared to the placebo group. The 60mg group also saw improvements in their quality of life.

The Cambridge-based company was founded in 2014 by CEO Alex Zhavoronkov, and in 2019 first published results about designing and testing drugs with its AI platform. Earlier this year, the company published its methodology for developing ISM001-055 in Nature Biotechnology. The company is currently enrolling patients in a U.S.-based clinical trial.

These results highlight "the potential of generative AI and robotics to facilitate the discovery, design, and development of innovative therapies," Zhavoronkov said in the announcement.

Enveda Begins Clinical Trial For Drug Derived From Nature Using AI

Colorado-based Enveda announced that it's begun clinical trials of ENV-294, an oral inflammatory agent for the treatment of atopic dermatitis. This is the first clinical trial for the startup, which raised its first seed round less than four years ago. The company's approach is relatively unique: its AI models are trained on biological data, which it searches for compounds that are potentially therapeutic. The company then refines those molecules to produce drugs.

The concept essentially takes medicine back to its roots, CEO and cofounder Viswa Colluru told Forbes. "Our first medicines just came from substances that worked in people," he said. "Morphine came from poppy seeds," he noted, just as "we got aspirin from willow bark."

Enveda takes advantage of modern computational biology to supercharge this effort, he explained. The company uses mass spectrometry to identify the chemical fingerprints of substances in biological samples, which enables them to process samples quickly without having to purify them. Then it trained transformer models to interpret those spectra and predict molecular structures. "Think of it like Alphafold, but for chemistry," Colluru said, enabling his company to "find natural product drug leads without any of the historical bottlenecks."

ENV-294 was derived from a molecule that plants use to handle inflammation, Colluru said, but with a very different molecular pathway than that employed by existing anti-inflammatories used for dermatitis or other inflammatory conditions, which can have rough side effects. The next step for the company is to complete its first clinical trial, which he said should happen by the beginning of the second quarter next year.

Pipeline & Deal Updates

Heart Disease: The FDA approved Johnson & Johnson's Varipulse system for the treatment of atrial fibrillation, a condition that causes irregular heartbeats and other issues.

Allergies: ARS pharmaceuticals has entered into an agreement with Danish company ALK-Abelló for an exclusive licensing agreement for ARS' nasal spray neffy, which can be used to treat anaphylaxis, in Europe, Canada and other countries. ARS will receive a $145 million upfront payment and is eligible for $320 million in milestone payments, plus royalties.

AI For Drug Discovery: Genesis Therapeutics, which is developing an AI platform for drug discovery, announced that Nvidia's venture capital arm made an equity investment in the company and will also collaborate with Nvidia in the development of its AI platform.

: Alentis Therapeutics, which is developing treatments for certain cancers, announced it has raised a $181.4 million series D round led by Orbimed, Novo Holdings and Jeito Capital.

Obesity: Metsera, which is developing new treatments for obesity and metabolic diseases, announced it has closed a $215 million series B round . The company is currently conducting phase 2 trials of its GLP-1 drug, which requires only monthly injections.

Parkinson's Disease: Discovery platform company Vesalius has entered into a collaboration deal with GSK to develop treatments of Parkinson's disease. Under the deal, Vesalius will get an $80 million upfront payment and will be eligible for milestone payments up to $570 million, plus royalties.

Computational Discovery: Novartis has entered into a collaboration with Schrödinger to use the latter's computational discovery platform to develop multiple drugs. Schrödinger will receive a $150 million upfront payment and be eligible for $2.3 billion in milestone payments, plus royalties.

Ozempic, Wegovy Linked To Lower Hospitalizations In Alcohol Addicts, Research Shows

Scientists in Finland and Sweden on Wednesday published the results of a study using 17 years of data that observed more than 220,000 people who were diagnosed with alcohol use disorder and either had obesity or Type 2 diabetes, conditions most commonly treated by glucagon-like peptide-1 receptor (GLP-1) medications.

The study found those taking semaglutide, the active ingredient in Ozempic and Wegovy, and liraglutide, the ingredient in Victoza, experienced reduced alcohol consumption and were less likely to be hospitalized for alcohol-related issues than their peers. Researchers warned the results of the study should be interpreted "cautiously" and that clinical trials will be needed to find if the improved outcomes were actually caused by the use of GLP-1 medications.

InnovationRx: Positive Clinical Trial Results For Generative AI-Designed Drug

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