DUBLIN – For quite some time, cardiometabolic disease has been largely off the map for most small biotechs and for the venture capital investors that support them. Is that situation about to change? Maybe, maybe not was the mixed message arising from a Bio-Europe Spring 2020 virtual panel discussion on cardiometabolic disease.
A lot of development dollars are shed when the FDA withdraws approval or requests that a drug be withdrawn from the market because new potential risks have come to light. And it’s not just the brand company that feels the loss.
Eisai Co. Ltd. is removing Belviq (lorcaserin) from the U.S. market due to the FDA’s concerns about an increased occurrence of cancer in a long-term trial evaluating the cardiovascular effects associated with the weight-loss drug.
GI Dynamics Inc.’s U.S. IDE trial of Endobarrier, which is designed for patients diagnosed with type 2 diabetes and obesity, is now underway with the first patient enrollment at Michigan Medicine in Ann Arbor, Mich. The FDA approved the pivotal STEP-1 clinical trial in August 2019 to evaluate the Endobarrier as a barrier between the small intestine and food to reduce calorie intake.
Kintai Therapeutics Inc. CEO, president and board member Paul-Peter Tak told BioWorld that the company aims to reach the clinic in the first quarter of next year with obesity agent KTX-0200, which has begun IND-enabling studies after showing sustained weight loss and improved markers of health in preclinical experiments.
HONG KONG – South Korean med tech Olive Healthcare Inc. has attracted ₩8 billion (US$6.91 million) in series B funding. The Seoul-based company is focused on abdominal fat scanning and breast cancer diagnosis, using nonradiative and noninvasive near infrared (NIR) technology, artificial intelligence (AI) algorithms, and big data processing for a customized medical service.
The obesity problem is one that is affecting a growing number of people globally. With both device and drug companies looking to take on the challenge of combating the problem, Allurion Technologies Inc. has set its sights on advancing a new approach in the U.S. Now, the Natick, Mass.-based company has scored $34 million in new funding through a securities financing and a growth capital term loan. The round was led by Novalis Lifesciences and Romulus Capital, with participation from Ido Investments and ex-Covidien CEO Jose Almeida.
Most weight loss interventions target obese or super-obese patients who have adjacent comorbidities, such as type 2 diabetes or sleep apnea. But Boston-based Gelesis aims to change that with its hydrogel pill Plenity.
HONG KONG – Olive Healthcare Inc., a South Korean biotech startup, said its abdominal fat scanner Bello has received an FDA approval to sell the device in the U.S. The company said it plans to launch the scanner in the country this December, after a market test. The miniature device is portable with a weight of 3.8 oz (107 g), measuring 3.9 inches (10 centimeters) long, 3.1 inches wide and 1.9 inches high.
Anorexia nervosa, Cynthia Bulik told BioWorld, has a long-term recovery rate of 25% and “the highest fatality rate of any psychiatric illness.” Those dismal statistics hint at the challenging nature of anorexia nervosa, but also at the shortcomings of current treatment options.
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