Biopharma Records 17% Decrease in BMI in Beta 2 :: InvestMacro


source: Streetwise Reports 07/14/2022

Shares of Rhythm Pharmaceuticals Inc. rose. increased by more than 30% after the company published provisional positive results from its phase II clinical study of cetylanotide in hypothalamic obesity. The data show that after 16 weeks of treatment with setmelanotide, patients experienced a mean reduction of 17.2% in BMI and weight loss of 15.8%.

Biologics Commercial Company Rhythm Pharmaceuticals Inc. (RYTM: NASDAQ)whose work focuses on the development and commercialization of treatments for patients with overeating and severe obesity caused by rare diseases of the melanocortin 4 receptor (MC4R) pathway, yesterday. announce Positive interim results from a phase II clinical trial evaluating setmelanotide, the company’s MC4R agonist, for the treatment of severe obesity and overeating in subjects with hypothalamic obesity.

The company advised that based on the very encouraging results collected in the study, it is now planning to consult with various regulatory agencies in order to move forward with a Phase 3 clinical trial.

The investigator in the second phase of the experiment, M. Jennifer Abu Zahab, MD, a physician at the McNeely Pediatric Diabetes Center and Children’s Endocrinology Clinic in Minnesota, says that “treatment options are very limited for patients with obesity in the hypothalamus, which results from damage to the medial section.” The hypothalamus region of the brain where MC4R pathway signaling is disrupted by some tumors and their treatment. Surgical intervention, radiotherapy, or even the growth and location of the tumor itself can cause severe, rapid, and debilitating weight gain.”



Dr. Abu Zahab added: “I believe these interim results of cetylanotide represent a major milestone for the hypothalamic obesity community. In this 16-week trial, patients treated with cetylanotide achieved a significant reduction in body weight, indicating that this precise treatment has the potential to transform Take care of this rare acquired obesity.”

Rhythm Pharmaceuticals indicated that the data released relate to 11 patients in the Phase 2 trial who met the evaluation criteria as of the data cut-off date of May 6, 2022. Of these 11 patients, 9 completed the full 16-week program and 2 had early discontinuation due to events Adverse effects associated with treatment.

The company advised that interim results were positive as treated patients showed a mean (median) reduction of 17.2% in their BMI with a reduction ranging from 6.7% to 37.2%. Participants additionally achieved a mean (median) 15.8% loss of body weight, equivalent to a mean (median) loss of 35.1 pounds of base weight. The company noted that the setmelanotide in the study also produced significant overall improvements in hunger scores.

Company President, President and CEO David Meeker, MD commented: “We are very encouraged by these initial findings, which reinforce the importance of the MC4R pathway in regulating hunger, calorie intake, energy expenditure, and ultimately body weight, as well as the potential role of setmelanotide in managing Diseases where this pathway is impeded… We look forward to partnering with regulators to finalize our Phase 3 development plans in the coming months, as we aim to expand our reach and make setmelanotide available to the approximately 5,000 to 10,000 people with hypothalamic obesity in the United States.”

The company noted that the setmelanotide phase II study is a multicenter clinical trial of 18 pediatric and adult patients ages 6 to 28 who were identified as having hypothalamic obesity. Patients in the study were given one daily injection of cetylanotide over a period of 16 weeks. The company advised that the primary endpoint of the trial was a measurement of “the percentage of patients who achieved a 5% reduction in BMI from baseline after 16 weeks of treatment compared to the historical control of <5% in this population".

The company explained, “IMCIVREE (setmelanotide) is a melanocortin 4 receptor (MC4R) agonist, which is part of the key biological pathway that regulates hunger, calorie intake, and energy expenditure.” Rhythm is actively developing setmelanotide as a targeted therapy with the goal of restoring impaired MC4R pathway functioning and believes that by doing so, it will unlock the ability of patients with rare genetic diseases of obesity to increase energy expenditure, reduce hunger and ultimately lose weight.

The company described hypothalamic obesity as “a rare, acquired form of severe obesity that occurs after damage to the hypothalamic region of the brain, which is responsible for controlling physiological functions such as hunger and weight regulation.” This condition often appears after growth or surgical removal of certain types of brain tumors. Patients with hypothalamic obesity typically experience rapid weight gain resulting from decreased energy and increased hunger during the first 6-12 months after surgery to remove tumors. The company stated that there are currently about 5,000 to 10,000 individuals in the United States living with the disease.

Rhythm Pharmaceuticals is a commercial-stage biopharmaceutical company headquartered in Boston, Massachusetts. The company is focused on developing and commercializing therapies to treat diseases associated with rare genetic obesity such as overeating and severe obesity caused by diseases of the rare melanocortin 4 receptor (MC4R) pathway.

The company advised that its leading precision medicine, IMCIVREE (setmelanotide), has been approved by the U.S. Food and Drug Administration (FDA) for use in chronic weight management in adults and children six years of age and older who have been diagnosed with “monogenic or syndromic obesity.” due to lack of POMC, PCSK1 or LEPR confirmed by genetic testing, or patients with a clinical diagnosis of Bardet-Biedl Syndrome (BBS).” The company claims that using its Rhythm Engine, it has compiled the largest known obesity DNA database containing more than 45,000 Serial sample of obese individuals. The company said it collected this data to aid in its efforts to improve understanding, diagnosis, patient care, and potential treatments for rare genetic deficiencies associated with obesity.

Rhythm Pharmaceuticals started Wednesday with a market capitalization of approximately $336.1 million with approximately 50.4 million shares outstanding and a short interest rate of approximately 6.3%. RYTM shares opened 5% lower at $6.34 (-$0.33, -4.95%) from the previous day’s closing price of $6.67. The stock traded between $6.34 and $8.8799 per share and closed at $8.77 (+ $2.10, +31.48%).

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