First AI-Generated Drug Enters Human Clinical Trials, Targeting Patients With Chronic Lung Diseases


June 29, 2023 | 1:17

The first AI-generated drug has entered Phase 2 clinical trials, with the first dose successfully administered to a human, Insilico Medicine announced yesterday.

The drug, currently called INS018_055, is being tested for the treatment of idiopathic pulmonary fibrosis (IPF), a rare and progressive type of chronic lung disease.

The 12-week study will include participants diagnosed with IPF.

This drug, which will be administered orally, will undergo the same rigorous testing to ensure its efficacy and safety as traditionally discovered drugs, but the process of its discovery and design is staggeringly new, said the CEO of Insilico Medicines Alex Zhavoronkov, PhD, in a statement to Fox News Digital.

However, with the latest advances in artificial intelligence, it has been developed much faster than traditional drugs.

How AI is transforming drug discovery

For any new drug, there are four steps, explained Zhavoronkov, who is based in Dubai.

Insilico Medicines CEO Alex Zhavoronkov (left), standing next to Dr. Feng Ren, said the drug would undergo the same tests to ascertain its efficacy and safety.
Insilica medicine

First, scientists must find a target, a biological mechanism that’s driving the disease, usually because it’s not working as expected, he said.

Second, they have to create a new drug for that goal, resembling a piece of a jigsaw puzzle, that would halt the progression of the disease without harming the patient.

The third step is to conduct animal studies first, then clinical studies in healthy human volunteers, and finally in patients.

The drug named INS018_055 which has entered Phase 2 clinical trials is being investigated for the treatment of idiopathic pulmonary fibrosis.
Insilica medicine

If these trials show positive results in helping patients, the drug reaches its fourth and final stage of approval by regulatory agencies for use as a treatment for that disease, Zhavoronkov said.

In the traditional process, he said, scientists find targets by scouring scientific literature and public health databases for disease-linked pathways or genes.

AI allows us to analyze massive amounts of data and find connections that human scientists might miss, and then imagine entirely new molecules that can be turned into drugs, Zhavoronkov said.

In this case, Insilico used artificial intelligence to both discover a new target for IPF and to generate a new molecule that could act on that target.

The company uses a program called PandaOmics to detect disease-causing targets by analyzing scientific data from clinical trials and public databases.

Once the target was discovered, the researchers fed it into Insilicos’ other tool, Chemistry42, which uses generative AI to design new molecules.

Essentially, our scientists gave Chemistry42 the specific characteristics they were looking for, and the system generated a set of possible molecules, ranked according to their probability of success, Zhavoronkov said.

The molecule chosen, INS018_055, is so named because it was the 55th molecule in the series and showed the most promising activity, he said.

Current treatments for idiopathic pulmonary fibrosis are pirfenidone and nintedanib.

While these drugs may provide some relief or slow the worsening of symptoms, they don’t reverse the damage or stop the progression, Zhavoronkov said.

They also have unpleasant side effects, especially nausea, diarrhea, weight loss and loss of appetite.

Alex Zhavoronkov (left) says artificial intelligence makes it possible to analyze huge amounts of data and find connections that human scientists might miss.
Insilica medicine

There are very few options for people with this terrible condition and the prognosis is poor, with most dying within two to five years of being diagnosed, Zhavoronkov explained.

Our initial studies have indicated that INS018_055 has the potential to address some of the limitations of current therapies.

Next steps

The Insilico team hopes that data from this new clinical trial will confirm the drugs’ safety and efficacy.

If our Phase IIa study is successful, the drug will then move into Phase IIb with a larger cohort of participants, said Sujata Rao, MD, chief medical officer of Hong Kong-based Insilicos, in a statement to Fox News. digital.

The Insilico team will attempt to advance their own method of using data to confirm the safety and efficacy of medicines.
Insilica medicine

During phase IIb, the main focus will be determining whether there is a significant response to the drug, Rao said.

Then, the drug will continue to be evaluated in a much larger group of patients, typically hundreds, in Phase III trials to confirm safety and efficacy before it can be approved by the FDA as a new treatment for patients with that condition. has explained.

One of the biggest challenges with these studies is patient recruitment, Rao said, particularly for a rare disease like idiopathic pulmonary fibrosis.

Patients must meet certain criteria to be considered for enrollment in the study, he noted.

Despite the challenges, Rao said the research team is optimistic that this drug will be ready to hit the market and reach patients who could benefit from it in the coming years.

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