Insilico Medicine announced yesterday that the first-ever drug produced by artificial intelligence has entered the second phase of clinical trials, and the primary dose has been successfully administered to a human.
The drug, now named INS018_055, is being tested for the treatment of idiopathic pulmonary fibrosis (IPF), a rare, progressive type of chronic lung disease.
The 12-week study will include participants diagnosed with IPF.
“This drug, which might be administered orally, will undergo the identical rigorous testing to make sure its effectiveness and safety as traditionally discovered drugs, however the strategy of its discovery and design is amazingly latest,” said Insilico Medicine CEO Dr. Alex Zhavoronkov, in statement to Fox News Digital.
“Nonetheless, due to the most recent advances in artificial intelligence, it has been developed much faster than traditional drugs.”
How AI is changing drug discovery
There are 4 steps to any latest drug, explained Zhavoronkov, who is predicated in Dubai.
![Insilico Medicine CEO Alex Zhavoronkov (left) said the drug will undergo the same tests to ensure it is effective and safe.](https://nypost.com/wp-content/uploads/sites/2/2023/06/newspress-collage-tlc5thi52-1688010356406.jpg?1687996689&w=1024&1687996689)
“First, scientists need to seek out the ‘goal’, the biological mechanism that drives the disease, actually because it is not working as intended,” he said.
“Second, they should create a latest drug for this purpose, just like a puzzle, that might block the progression of the disease without harming the patient.”
The third step is to conduct research, first in animals, then in clinical trials in healthy volunteers, and eventually in patients.
![The drug, called INS018_055, which has entered phase 2 clinical trials, is being tested for the treatment of idiopathic pulmonary fibrosis.](https://nypost.com/wp-content/uploads/sites/2/2023/06/newspress-collage-w4j8lj0et-1688010704467.jpg?1687996903&w=1024&1687996903)
“If these tests show positive leads to helping patients, the drug will reach the fourth and final stage – approval by regulatory agencies to be used within the treatment of this disease,” said Zhavoronkov.
In the normal process, he said, scientists find targets by searching the scientific literature and public health databases for pathways or genes linked to diseases.
“AI allows us to research huge amounts of information and find connections that scientists might miss, after which ‘imagine’ completely latest molecules that may be changed into drugs,” said Zhavoronkov.
On this case, Insilico used AI to each discover a latest goal for IPF and generate a latest molecule that would interact with that concentrate on.
The corporate uses a program called PandaOmics to detect disease-causing targets by analyzing scientific data from clinical trials and public databases.
After discovering the goal, the researchers fed it into Insilico’s other tool, Chemistry42, which uses generative AI to design latest molecules.
“Essentially, our scientists provided Chemistry42 with the precise features they were on the lookout for, and the system generated a series of possible molecules ranked based on their likelihood of success,” said Zhavoronkov.
The chosen molecule, INS018_055, was so named since it was the fifty fifth molecule within the series and showed probably the most promising activity, he said.
Current treatments for idiopathic pulmonary fibrosis are pirfenidone and nintedanib.
While these drugs may provide relief or slow the worsening of symptoms, they don’t reverse the damage or stop the progression of the disease, Zhavoronkov said.
In addition they have unpleasant unwanted effects, most notably nausea, diarrhea, weight reduction, and lack of appetite.
![Alex Zhavoronkov (left) says that AI allows you to "analyze huge amounts of data and find connections that scientists might miss."](https://nypost.com/wp-content/uploads/sites/2/2023/06/newspress-collage-rs041cx1k-1688010969466.jpg?1687996822&w=1024&1687996822)
“There are only a few options for people with this terrible condition, and the prognosis is poor – most will die inside two to 5 years of diagnosis,” Zhavoronkov explained.
“Our preliminary research has shown that INS018_055 has the potential to handle a few of the limitations of current therapies.”
Next steps
The Insilico team hopes that the information from the newly launched clinical trial will confirm the security and effectiveness of the drug.
“If our Phase IIa trial is successful, the drug will then move to Phase IIb with a bigger cohort of participants,” Dr. Sujata Rao of Hong Kong, Insilico’s chief physician, said in an announcement to Fox News Digital.
![The Insilico team will try to push through its method of using data to prove the drug's safety and effectiveness.](https://nypost.com/wp-content/uploads/sites/2/2023/06/newspress-collage-2j3oxtsdl-1688011371875.jpg?1687997132&w=1024&1687997132)
During phase IIb, the primary focus might be to find out if there may be a major response to the drug, Rao said.
“The drug will then be evaluated in a much larger group of patients – typically lots of – in phase III trials to substantiate safety and efficacy before being approved by the FDA as a latest drug for patients with this condition,” he explained.
Rao said certainly one of the largest challenges with these studies is recruiting patients, especially for a rare disease like idiopathic pulmonary fibrosis.
“Patients must meet certain criteria to be included within the study,” he noted.
Despite the challenges, Rao said the research team is optimistic that this drug might be able to hit the market – and reach patients who may gain advantage from it – inside the subsequent few years.