CAMBRIDGE, Mass., April 02, 2020 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA), a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases, today provided an update on the Company’s clinical trial activities and business operations in light of the COVID-19 pandemic.
“The COVID-19 pandemic has greatly impacted the global healthcare system. During these challenging times, our utmost priority is the health and safety of patients in our clinical studies and the healthcare professionals who care for them, as well as our team. To that end, we have implemented measures to protect their well-being while ensuring our ability to maintain the continuity of our business,” said Craig Wheeler, President and Chief Executive Officer at Momenta Pharmaceuticals. “At this time, we are in active communication with clinical sites to be sure patients enrolled in our studies have uninterrupted access to our investigational drugs. However, in light of COVID-19, its global impact on healthcare systems and patients and healthcare professionals involved in clinical trials, we are suspending enrollment in certain ongoing clinical trials and delaying the launch of planned studies until conditions permit. We are closely monitoring this situation as it continues to evolve and will provide additional updates, as necessary, in our first quarter earnings release.”
Update on Clinical Trial Activities:
Momenta remains committed to its development programs, but recognizes the impact and risks imposed by COVID-19 on the global healthcare system. The Company is making all efforts to allow patients currently enrolled in its clinical studies to continue unimpeded and is in close contact with clinical sites to ensure patients have access to our investigational drugs. Momenta has also implemented additional measures to protect the health and safety of patients and healthcare professionals involved with its clinical studies, and to preserve the integrity of its clinical data.
- Nipocalimab (M281): a fully human anti-neonatal Fc receptor (FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal antibody (mAb)
- Vivacity-MG is the Company’s Phase 2 clinical study of nipocalimab in generalized myasthenia gravis (gMG). As previously reported, this trial achieved target patient enrollment in February 2020. The Company currently remains on track to report topline data from this study in the third quarter of 2020.
- Unity, the Company’s global multi-center Phase 2 clinical study of nipocalimab in hemolytic disease of the fetus and newborn (HDFN), continues to enroll patients at sites where they can be safely accommodated. At this time, based on the life-threatening nature of HDFN, the Company does not intend to pause enrollment of the study but anticipates a slower pace of enrollment due to the overall global impact of COVID-19.
- The Company’s Energy Study, an adaptive Phase 2/3 clinical study of nipocalimab in warm autoimmune hemolytic anemia (wAIHA), has been activating sites globally. The Company will continue to activate sites but has temporarily suspended patient enrollment.
- M254 (hsIgG): a hypersialylated immunoglobulin designed as a high potency alternative for intravenous immunoglobulin (IVIg)
- M254 is currently being evaluated in Momenta’s multi-part Phase 1/2 study in idiopathic thrombocytopenic purpura (ITP). Momenta continues to enroll lower dose cohorts in Part B of the ongoing trial, however most of the sites have suspended enrollment due to the COVID-19 pandemic. As a result and in anticipation of slower enrollment, the Company may not be able to report interim data as planned for the second quarter of 2020. The ITP study Parts C and D, which are being evaluated in the context of emerging Part B data, will be delayed until Part B is complete and depending on then-prevailing conditions for clinical trials.
- The Company also expects that its planned Phase 2 study of M254 in chronic inflammatory demyelinating polyneuropathy (CIDP) will commence in 2021.
Momenta is closely monitoring the evolving situation and expects to resume patient enrollment and initiate delayed studies when conditions permit.
Update on Business Operations:
Momenta has implemented measures to mitigate the spread of COVID-19 and protect the health and safety of its personnel amid this pandemic. In line with guidance from the U.S. Centers for Disease Control and Prevention (CDC) and the state of Massachusetts, the Company’s workforce is working remotely, and the Company has suspended all business travel.
Momenta believes it has sufficient manufactured drug material to supply its ongoing clinical studies. At this time and subject to further COVID-19 implications, the Company does not anticipate any disruptions to its clinical supply.
The Company will provide further business updates, including its 2020 operating expense guidance, with its first quarter 2020 financial results.
About Momenta
Momenta Pharmaceuticals is a biotechnology company with a validated innovative scientific platform focused on discovering and developing novel therapeutics to treat rare, immune-mediated diseases and advancing its late stage biosimilar portfolio. The company is headquartered in Cambridge, MA.
To learn more about Momenta, please visit www.momentapharma.com, which does not form a part of this press release.
Momenta’s logo, trademarks, and service marks are the property of Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners.
Forward-Looking Statements
Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements about the use, design, timing, enrollment, strategy and goals of clinical trials and the availability, timing and announcement of data and results, ; the efficacy, safety, tolerability, potency, convenience and commercial potential of our product candidates and Momenta’s expectations regarding the impact of the COVID-19 pandemic on its clinical trials, clinical supply and business operations. Forward-looking statements may be identified by words such as “anticipate” "believe," "continue," expect”, “intend” "plan to," "potential," "will," and other similar words or expressions, or the negative of these words or similar words or expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors, including the impact of the COVID-19 pandemic on the status, enrollment, timing and results of our clinical trials, the supply of our manufactured drug materials and the continuity of our business, the unpredictable nature of early stage development efforts for our product candidates; safety, efficacy or tolerability problems with our product candidates; unexpected adverse clinical trial results; and those referred to under the section "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2019 filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. The Company is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
INVESTOR CONTACT:
Patty Eisenhaur
Momenta Pharmaceuticals
1-617-395-5189
IR@momentapharma.com
MEDIA CONTACT:
Karen Sharma
MacDougall
781-235-3060
ksharma@macbiocom.com