Chemomab Therapeutics (Nasdaq: CMMB), which is developing treatments for fibro-inflammatory (scarring) diseases, rose 14% on Friday and is up an additional 13% today, following publication of its second quarter financial report and receipt of positive trial results. Chemomab, which merged into the stock market shell of Anchiano Therapeutics (Biocancel) in 2021 listed on Wall Street at a relatively early stage in the development of its products. Since then it has lost over 90% of its value and is currently trading with a market cap of $22.76 million.
Chemomab CEO and cofounder Dr. Adi Mor tells "Globes," "Scarring is part of a variety of diseases and we have a drug with a new mechanism against it. We decided to choose the rare liver scarring disease PSC, which causes scarring in the bile ducts and ultimately the need for a liver transplant in 20% of patients, and there is no cure for the disease. Even those who have a liver transplant may develop the disease in the new liver."
The trial was conducted testing the drug against a placebo for 15 weeks and will continue so that both groups will receive the drug for another 33 weeks. "The study was not designed to show effectiveness, but we showed changes in the most important biological markers in the development of the disease, and in some of them a statistically significant difference was recorded." Because of the relative rarity of the disease, the company estimates that will be able to do a single and not particularly large Phase III trial.
One of the reasons why the company probably had difficulty getting moving, is the FDA's requirement for a liver biopsy in phase III trials of drugs for PSC. Mor says, "The problem is that this disease appears as a type of 'spots' on the liver and a biopsy may miss it." These requirements have led companies and investors alike to shy away from PSC.
"But lately we have been hearing from other companies in the field that the FDA is talking to them about other indicators, such as the stiffness of the liver, an indicator in which we succeeded in Phase II and can be measured by ultrasound or MRI. We will meet with the FDA later this year, and we assume that their official answer regarding the desired structure for the trial will arrive in early 2025." Even in the small likelihood that a biopsy will be required, she says, "It doesn't take this drug off the table."
Mor points out that most rivals are developing drugs aimed at the symptoms of the disease, while Chemomeb targets the mechanism. "Also in terms of safety profile, we are in an excellent place."
The company's investors include OrbiMed and other funds as well as tech entrepreneur Peter Thiel.
Published by Globes, Israel business news - en.globes.co.il - on August 26, 2024.
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