First AI-generated drug enters human clinical trials, targeting chronic lung disease patients
(Article)
Insilico Medicine, a leading artificial intelligence (AI) drug discovery company, has announced that the first-ever drug generated by AI has entered Phase 2 clinical trials. The drug, currently known as INS018_055, is being tested for the treatment of idiopathic pulmonary fibrosis (IPF), a rare and progressive chronic lung disease.
The 12-week trial will include participants diagnosed with IPF. The drug will be administered orally and will undergo rigorous testing to ensure its effectiveness and safety. Insilico Medicine’s CEO Alex Zhavoronkov, PhD, stated that while the process of discovering and designing the drug is incredibly new, it has been developed much faster than traditional drugs due to the latest advances in AI.
Explaining the steps involved in drug discovery, Zhavoronkov said that scientists first need to identify the biological mechanism that is driving the disease. They then create a drug that can target and block the progression of the disease without harming the patient. The drug undergoes studies in animals, followed by clinical trials in healthy human volunteers, and finally in patients. If the tests show positive results, the drug can be approved for use as a treatment for that disease.
Zhavoronkov emphasized how AI has transformed the drug discovery process. AI allows scientists to analyze massive quantities of data and find connections that may be missed by human scientists. In the case of INS018_055, AI was used to discover the target for IPF and generate a new molecule that could act on that target. Insilico Medicine utilizes a program called PandaOmics to detect disease-causing targets and Chemistry42 to design new molecules using generative AI.
INS018_055, the chosen molecule, has shown promising activity in treating IPF. The current treatments for the disease, pirfenidone and nintedanib, only provide temporary relief and have unpleasant side effects. INS018_055 has the potential to address these limitations and improve patient outcomes.
The data from the ongoing Phase 2 clinical trial will determine the drug’s safety and effectiveness. If successful, the drug will proceed to Phase 2b with a larger cohort of participants. The primary objective of Phase 2b will be to determine significant response to the drug. Following that, the drug will be evaluated in a much larger group of patients in Phase 3 studies to confirm its safety and effectiveness.
Recruiting patients for these trials, especially for a rare disease like IPF, is a major challenge. However, the Insilico team remains optimistic and believes that the drug will be ready for market and reach patients in the next few years.
FAQs:
Q: What is the name of the drug being tested in Phase 2 clinical trials?
A: The drug is currently referred to as INS018_055.
Q: What is the purpose of the drug?
A: The drug is being tested for the treatment of idiopathic pulmonary fibrosis (IPF), a rare and progressive chronic lung disease.
Q: How was the drug developed?
A: The drug was generated by artificial intelligence (AI) using programs called PandaOmics and Chemistry42.
Q: What are the current treatments for IPF?
A: The current treatments for IPF are pirfenidone and nintedanib.
Q: What are the potential benefits of INS018_055?
A: INS018_055 has the potential to address the limitations of current IPF treatments and improve patient outcomes.
Q: What are the next steps for the drug?
A: Following the Phase 2 clinical trial, the drug will proceed to Phase 2b and then Phase 3 studies to confirm its safety and effectiveness.
Q: What are the challenges in conducting clinical trials for a rare disease like IPF?
A: One of the main challenges is recruiting a sufficient number of patients who meet the criteria for trial enrollment.
Q: When is the drug expected to be available for patients?
A: The research team is optimistic that the drug will be ready for market and reach patients in the next few years.
Human Clinical Trials Initiated for AI-Developed Drug Addressing Chronic Lung Ailments
Insilico Medicine made a groundbreaking announcement yesterday, revealing that the first-ever drug developed by artificial intelligence (AI) has entered Phase 2 clinical trials. The drug, currently known as INS018_055, has been administered to a human for the first time and is being tested for the treatment of idiopathic pulmonary fibrosis (IPF), a rare and progressive type of chronic lung disease.
Insilico Medicine’s CEO, Alex Zhavoronkov, PhD, stated in a statement to Fox News Digital that although the drug will undergo the same rigorous testing as traditional drugs to ensure its effectiveness and safety, the process of its discovery and design is significantly new. He also mentioned that with the latest advancements in AI, the drug was developed much faster compared to traditional drugs.
Alex Zhavoronkov, who is based in Dubai, explained that there are four steps involved in the development of any new drug. First, scientists must identify a “target,” which is a biological mechanism responsible for driving the disease. Second, they need to create a drug, similar to a puzzle piece, that can block the progression of the disease without harming the patient. Third, studies are conducted involving animals, healthy human volunteers, and finally patients. If positive results are obtained during these tests, the drug proceeds to the fourth and final step – approval by regulatory agencies for use as a treatment for the specific disease.
In the traditional drug development process, targets are found by analyzing scientific literature and public health databases for pathways or genes associated with diseases. However, AI allows for the analysis of vast amounts of data, enabling the detection of connections that human scientists might overlook. Insilico used AI technology to discover a new target for IPF and generate a molecule to act on that target. The company utilized a program called PandaOmics to detect disease-causing targets and another tool called Chemistry42, which employs generative AI to design new molecules.
The chosen molecule, INS018_055, was the 55th molecule in the series and displayed the most promising activity. Zhavoronkov mentioned that this drug has the potential to address some of the limitations of current therapies for IPF, such as pirfenidone and nintedanib, which only provide partial relief and have unpleasant side effects.
The Insilico team is now looking forward to collecting data from the ongoing clinical trial to confirm the drug’s safety and effectiveness. If the Phase IIa study is successful, the drug will progress to Phase IIb, involving a larger cohort of participants. During Phase IIb, the primary objective will be to determine if there is a significant response to the drug. Following this, the drug will undergo evaluation in a much larger group of patients in Phase III studies to confirm its safety and effectiveness before receiving approval from the FDA.
Recruiting patients for these trials, especially for a rare disease like IPF, presents a significant challenge. However, the Insilico team remains optimistic that the drug will be ready for market and reach patients in need within the next few years.