Rhythm Pharmaceuticals Provides Updates on Leadership Transition and Business Operations
Hunter Smith, Chief Financial Officer, appointed Interim Chief Executive Officer following completion of NDA submission to FDA
Precautionary measures in place to mitigate impact of COVID-19 on clinical programs
“On behalf of the Board, I am pleased that Hunter and the Rhythm management team will continue their excellent stewardship of the Company and dedication to transforming the care of people living with rare genetic disorders of obesity while we continue our search for a permanent CEO,” said
As previously disclosed, the Company’s Board of Directors has formed a search committee and retained an executive search firm to assist in identifying Dr. Gottesdiener’s permanent successor. The Board has made significant progress in the search process and is considering a number of highly qualified candidates.
“I look forward to working closely with the Board, Murray and Nithya, our colleagues on the management team, and the entire Rhythm team to advance setmelanotide,”
COVID-19 and Business Continuity
To help protect the health and safety of the patients, caregivers and healthcare professionals involved in its ongoing clinical trials of setmelanotide, as well as its employees, in response to the novel coronavirus (COVID-19) pandemic, Rhythm has implemented a number of precautionary clinical and operational measures to protect patient well-being and ensure consistent and appropriate clinical trial conduct.
With many clinical trial sites already closing down in response to COVID-19-related country- and state-level guidelines and more closures expected, Rhythm and study investigators and staff remain focused on the safety, treatment and monitoring of patients currently enrolled in these trials. Rhythm has introduced measures to ensure patients in ongoing clinical trials continue to be monitored as scheduled and receive their study drug.
POMC Deficiency Obesity and LEPR Deficiency Obesity
Today, Rhythm announced that it has completed its rolling submission of an NDA to the FDA for setmelanotide for the treatment of pro-opiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity. The FDA typically has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Rhythm has requested priority review for the application which, if granted, could provide a target FDA review period of six months from the application filing date. Rhythm continues to anticipate that it will submit a Marketing Authorization Application (MAA) to the
Ongoing Clinical Trials of Setmelanotide
Rhythm continues to expect to meet disclosed timelines for reporting data from its pivotal Phase 3 trial in Bardet-Biedl Syndrome (BBS) and Alström Syndrome and Phase 2 Basket Study. The Company anticipates announcing topline data in the fourth quarter of 2020 or early in the first quarter of 2021 from the Phase 3 BBS and Alström syndrome trial, which completed enrollment in
Rhythm currently believes there will be no disruption of clinical supply of setmelanotide. The Company’s contract manufacturers have indicated that they have appropriate plans and procedures in place to ensure uninterrupted future supply of clinical and commercial-grade setmelanotide, subject to potential limitations on their operations due to COVID-19.
Consistent with guidelines from the
Rhythm is a late-stage biopharmaceutical company focused on the development and commercialization of therapies for the treatment of rare genetic disorders of obesity. In
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the potential, safety, efficacy, and regulatory and clinical progress of setmelanotide, including the anticipated timing for enrollment and design of clinical trials, the timing for approval of an NDA and for submission of an MAA, the impact of COVID-19 on the Company’s clinical trials, regulatory submissions and supply of setmelanotide, the ongoing CEO search, and expectations surrounding future guidance, the release of results of clinical trials and updates on patient enrollment. Statements using words such as “expect”, “anticipate”, “believe”, “may”, “will” and similar terms are also forward-looking statements. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the impact of COVID-19 and other global economic factors, the impact of our management transition, our ability to enroll patients in clinical trials, the design and outcome of clinical trials, the impact of competition, the ability to achieve or obtain necessary regulatory approvals, risks associated with data analysis and reporting, our liquidity and expenses, and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended
Head of Investor Relations and Corporate Communications
Stern Investor Relations, Inc.
Berry & Company Public Relations
Source: Rhythm Pharmaceuticals, Inc.