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Results of Phase 1 Study Presented in Presidents Oral Session Presentation at the American Diabetes Association 77th Scientific Sessions

June 13, 2017

Camarillo, CA - REMD Biotherapeutics, Inc. (“REMD Bio”), together with its subsidiary, Beijing CoSci-REMD Bio Med-Tech Co, Ltd (“CoSci-REMD Bio”), together with its subsidiary, Beijing-based Cosci-REMD Biotherapeutics (“Cosci-REMD Bio”), today announced data from a Phase 1 clinical study of REMD-477 in patients with type 1 diabetes were presented during the Presidents Oral Session at the American Diabetes Association’s 77th Scientific Sessions (ADA 2017) in San Diego. The results showed that a single dose of REMD-477 substantially reduced daily insulin requirements and glucose levels without increasing hypoglycemia (low blood glucose levels) in patients.

The randomized, double-blind, placebo-controlled study enrolled 21 patients (8 men, 13 women) with type 1 diabetes. Patients were admitted for a five-day, in-patient observation period, during which their glucose levels were maintained by following a dietary plan and through continuous intravenous (IV) insulin infusion. All patients’ glucose levels were monitored by continuous glucose monitoring (CGM) for approximately two weeks prior to and eight weeks after the in-patient part of the study (‘in-patient period’). Daily insulin use and glucose levels of patients were measured on day one of the in-patient period. On the second day of the in-patient period, half of the patients on the study (10 patients) received a single 70 milligram (mg) subcutaneous injection of REMD-477, while the other half (11 patients) received a subcutaneous injection of placebo. Daily insulin use and glucose levels were checked again on days three and four of the in-patient period and after release from the in-patient setting.

Results of a comparison of daily insulin use and glucose levels demonstrated that a single dose of REMD-477 decreased daily insulin use by up to 26 percent (12 units) during the in-patient period compared to placebo. Average daily glucose concentrations decreased by 20 to 31 mg/dL without increasing hypoglycemia in the first three weeks after release from the in-patient setting for patients on the REMD-477 arm of the study.

Glucagon, a hormone that increases blood sugar, works in concert with insulin to maintain glucose levels in humans. Elevated glucagon levels have been found in every form of diabetes. REMD-477 is a fully human antibody that specifically binds to the glucagon receptor and blocks the action of glucagon.

Jeremy H. Pettus, M.D., Assistant Professor, Division of Endocrinology at UCSD and a principal investigator on the study presented the results at ADA 2017 in San Diego. “The results from this study of REMD-477 substantiate   the long-standing theory that blocking the glucagon pathway can have a significant impact in patients with type 1 diabetes, by improving glucose levels and lowering insulin doses,” said Dr. Pettus. “Therapies that improve glucose control and avoid hypoglycemia represent an important unmet need in the treatment of type 1 diabetes.”

REMD Bio is planning to initiate a follow-up study of REMD-477 to evaluate the efficacy, safety, and pharmacodynamics of multiple doses in approximately 75 patients with type 1 diabetes. For more information about this study (NCT03117998), including criteria for participating and enrolling centers, please visit www.clinicaltrials.gov.

“REMD Bio is honored to have this study chosen for a Presidents Oral Presentation at ADA 2017. These results represent a giant step forward in the development of REMD-477 for the treatment of type 1 diabetes. We look forward to further evaluating the potential therapeutic utility of REMD-477 in type 1 diabetes and other metabolic diseases,” stated Dung ”Zung” Thai, M.D., Ph.D., Chief Medical Officer of REMD Bio and Cosci-REMD Bio.

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Contact: Leah Grant (leahgrant@remdbio.com)



Glucagon-Blocking Drug Reduces Need for Insulin and Improves Blood Glucose Levels for Patients with Type 1 Diabetes

June 13, 2017

San Diego, CA - A single dose of the glucagon-blocking drug REMD-477 can substantially reduce the amount of insulin needed and improve glucose levels without increasing hypoglycemia (low blood glucose levels) in patients with type 1 diabetes, according to the study, “REMD-477, a Human Glucagon Receptor (GCGR) Antibody, Reduces Daily Insulin Requirements and Improves Glycemic Control in People with Type 1 Diabetes (T1D),” presented today at the American Diabetes Association’s 77th Scientific Sessions® at the San Diego Convention Center in San Diego. Glucagon is a hormone produced by the pancreas that raises blood glucose and works together with insulin, which has the opposite effect, to tightly regulate blood glucose concentrations. In individuals with diabetes, glucagon effects may not be appropriately balanced by insulin, resulting in elevated blood glucose.

The double-blind, randomized, placebo-controlled study enrolled 21 adult patients (8 men and13 women) with T1D. Prior to being admitted for a five-day, in-patient observation period, all participants’ glucose levels were measured by Continuous Glucose Monitoring (CGM). While under observation, all patients received the same meals and a continuous IV insulin infusion to help maintain glucose levels.

On the second day of observation, 10 patients received a single 70 milligram (mg) subcutaneous injection of the glucagon-blocking drug, REMD-477—a fully human antibody that specifically binds to and blocks glucagon receptor signaling for the treatment of metabolic disorders, including T1D. The remaining 11 patients received a placebo injection. (REMD-477 was discovered with Xenomouse technology, which recapitulates a human antibody response in the mouse, and the antibody sequences are fully human.)  

Daily insulin use and glucose levels of patients who received REMD-477 were compared on day one versus day four of observation to those who received placebo. Results indicated that those who received the REMD-477 treatment were able to reduce daily insulin use by 26 percent (12 units), compared to those who received the placebo (p=0.02).

Participants received CGM for 8 weeks after inpatient observation. Average daily glucose assessed by CGM was 20 to 31 mg/dL lower in the REMD-477 patients than in the placebo patients during the 3 weekly periods after inpatient observation (p<0.05). In addition, the REMD-477 patients’ blood glucose levels were improved without increasing low blood glucose events. Given the long-acting nature and persistent blood concentrations of REMD-477, it is likely that patients may be dosed once per week.

“Our study strongly supports the long-held theory that blocking glucagon may have a significant clinical impact on care for people with type 1 diabetes by improving glucose levels and lowering insulin doses,” said Jeremy Pettus, MD, assistant professor of medicine in the endocrinology department at the University of California, San Diego. “We expected that the drug [REMD-477] would have an effect, yet the degree to which the drug reduced the need for insulin and improved patients’ blood sugar levels without increasing hypoglycemia events was a surprise.”

This study measured the effect of the glucagon-blocking drug after only one injection. The follow-up study will focus on treating more patients over a longer period of time and will compare weekly injections of two different dose strengths. The results of the follow-up study should provide a more complete picture of how REMD-477 may affect patients’ blood glucose levels, insulin use and weight in an outpatient setting.

To speak with Dr. Pettus, please contact the Association’s media relations team on-site at the San Diego Convention Center on June 9 - 13 by phone at 619-525-6250 or by email at press@diabetes.org. To view the source version, click here



REMD BIOTHERAPEUTICS Announces dosing of first type 1 diabetes patient with remd-477, a glucagon receptor monoclonal antibody

April 6, 2016 

Camarillo, CA - REMD Biotherapeutics, Inc. (“REMD Bio”), together with its subsidiary, Beijing CoSci-REMD Bio Med-Tech Co, Ltd (“CoSci-REMD Bio”), today announced that the first patient with type 1 diabetes was dosed with REMD-477 on their phase 1b clinical study in the United States. The randomized, double-blind, placebo- controlled study to evaluate the safety, tolerability, phyarmacodynamics, and glucose and insulin dose-lowering properties of REMD-477 in up to 20 patients with type 1 diabetes administered a single subcutaneous injection will enroll at Washington University School of Medicine in St. Louis and at U.C. San Diego (UCSD) School of Medicine.

“While insulin is a primary treatment for type 1 diabetes, exogenous insulin treatment may not be completely effective at controlling the disease, and hypoglycemia is a major and sometimes life- threatening side effect of insulin therapy, and a daily fact of life, for people with this disease. An additive therapy that can reduce daily insulin doses and reduce hyperglycemia may substantially reduce complications, and improve diabetic control and quality of life for type 1 diabetic patients,” stated Robert R. Henry, M.D., Professor of Medicine at UCSD, Chief of the Center for Metabolic Research at the Veterans Affairs Healthcare System in San Diego, and Former President, American Diabetes Association, National Science & Medicine and Western Region.

“Glucagon is a hormone that works in concert with insulin to maintain glucose levels, yet therapy for type 1 diabetes has focused almost exclusively on insulin replacement. I believe failure to address glucagon dysregulation in type 1 diabetes represents a major missed opportunity in the current treatment approach. We hope the results of this study of REMD-477, an antibody that blocks the glucagon receptor, will confirm the role of glucagon as a major cause of hyperglycemia in type 1 diabetes,” added Jeremy H. Pettus, M.D., Assistant Professor, Division of Endocrinology at UCSD and a principal investigator on the study.

“Recently research has been directed at the glucagon pathway as a therapeutic target, including developing antagonists of glucagon or glucagon receptor. The current trial will evaluate the safety and ability of REMD-477 to control blood sugar and its impact on the insulin requirements in patients with type 1 diabetes. The results from this study will increase our understanding of the mechanisms that cause high blood sugar in patients with type 1 diabetes, and could lead to changes in the medical management of this disease,” added Samuel Klein, M.D., William H. Danforth Professor of Medicine and Nutritional Science and Director of the Center for Human Nutrition at Washington University School of Medicine, and a principal investigator on the study.

“This phase 1b study is building on results of the extensive studies in multiple rodent type 1 diabetes models with glucagon receptor antibody and the first-in-human clinical study of REMD- 477 performed by Amgen in healthy volunteers in which there were no significant drug-related adverse events and there appeared to be a dose-dependent decline in glucose levels. Dosing the first patient with type 1 diabetes is another milestone for the Company in the development of REMD-477 for additional indications beyond our ongoing clinical trial in type 2 diabetes,” stated Hai Yan, Ph.D., President, co-founder, and CEO of REMD Bio and CoSci-REMD Bio. 

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Contact: Leah Grant (leahgrant@remdbio.com)


REMD Biotherapeutics TO begin Phase 1b Clinical Study of REMD-477 for Patients with Type 1 Diabetes

December 15, 2015 

Camarillo, CA - REMD Biotherapeutics, Inc. (“REMD Bio”), together with its subsidiary, Beijing-based Cosci-REMD Biotherapeutics (“Cosci-REMD Bio”), today announced that the U.S. Food and Drug Administration (FDA) has approved the planned clinical study of the Company’s lead product candidate, REMD-477, in patients with type 1 diabetes. REMD Bio is poised to initiate this clinical study in January 2016.

“Insulin is the primary therapy for patients with type 1 diabetes. Unfortunately, insulin often does not provide optimal blood sugar control, and many patients experience large fluctuations in blood sugar levels, including life-threatening hypoglycemia. The current trial will evaluate the ability of REMD-477, which blocks the action of glucagon (a hormone that increases blood sugar), on blood sugar control and insulin requirements in patients with type 1 diabetes. The results from this study will increase our understanding of the mechanisms that cause high blood sugar in patients with type 1 diabetes, and could lead to a paradigm shift in the medical management of this disease,” said Samuel Klein, M.D., William H. Danforth Professor of Medicine and Nutritional Science and Director of the Center for Human Nutrition at Washington University School of Medicine, and a principal investigator on the study.

The study is a phase 1b, double-blind, placebo-controlled, randomized study to evaluate the safety, tolerability, and pharmacodynamics of REMD-477 following a single dose in insulin-treated patients with type 1 diabetes. The study is expected to enroll a total of 20 patients at Washington University School of Medicine in St. Louis and at U.C. San Diego School of Medicine.

“This phase 1b clinical study builds on the promising preclinical data reported in PNAS earlier this year and is a step toward proof-of-concept for REMD-477 for the treatment of type 1 diabetes. After having just initiated a phase 2 clinical study in type 2 diabetes in September, we are excited to expand our clinical scope with this study in type 1 diabetes,” stated Hai Yan, Ph.D., President, co-founder, and CEO of REMD Bio and Cosci-REMD Bio. 

“The initiation of this clinical study is another important milestone for REMD Bio and Cosci-REMD Bio. We are pleased with the quick response from FDA, who reviewed and approved our IND in a month,” stated Hai Yan, Ph.D., President, co-founder, and CEO of the Companies.

About the PNAS Publication
As reported in the Proceedings of National Academy of Sciences (PNAS) earlier this year, in preclinical studies REMD-477 completely corrected hyperglycemia within one week after treatment and restored normal levels of HbA1c (a marker of prolonged diabetes control) in rodent models of type 1 diabetes after chronic treatment. The research reported in the PNAS article was performed by REMD Bio and a team at the University of Texas Southwestern Medical Center in Dallas led by Roger Unger, M.D., Professor and Touchstone/West Distinguished Chair in Diabetes Research. [Wang MY, et al., PNAS. 2015; 112(8): 2503-8.] 

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Contact: Leah Grant (leahgrant@remdbio.com )


REMD BIOTHERAPEUTICS PHASE 2 CLINICAL STUDY OF REMD-477 FOR PATIENTS WITH TYPE 2 DIABETES NOW ENROLLING

November 19, 2015 

Camarillo, CA - REMD Biotherapeutics, Inc. (“REMD Bio”), together with its subsidiary, Beijing-based Cosci-REMD Biotherapeutics (“Cosci-REMD Bio”), today announced that its phase 2 clinical study of REMD-477 is currently enrolling patients with type 2 diabetes. The Company received approval from the U.S. Food and Drug Administration (FDA) of its investigational new drug (IND) application to begin the phase 2 clinical study in September.
The study is a randomized, placebo-controlled, double-blind, dose escalation study to evaluate the safety and tolerability following single and repeated doses of REMD-477 in approximately 72 patients with type 2 diabetes. Changes in glucose, HbA1c, and insulin levels will also be measured. The study has a two-part design: the first part for dose escalation of REMD-477 and the second part for dosing frequency at specific doses determined in the first part of the study. The study is recruiting patients in San Diego, Miami, and San Antonio.

“The initiation of this clinical study is another important milestone for REMD Bio and Cosci-REMD Bio. We are pleased with the quick response from FDA, who reviewed and approved our IND in a month,” stated Hai Yan, Ph.D., President, co-founder, and CEO of the Companies.

Glucagon is a hormone that stimulates the liver and kidneys to produce glucose. It works in concert with insulin to maintain glucose levels in humans. Elevated glucagon levels have been found in every form of diabetes. Attenuating glucagon action by blocking the glucagon receptor will likely reduce endogenous glucose production, lower glucose levels, and improve diabetes control. REMD-477 is a fully human antibody that specifically binds to and blocks the glucagon receptor functions. In several rodent models of type 2 diabetes, REMD-477 significantly suppressed glucagon receptor signaling, corrected hyperglycemia, and normalized glucose tolerance profiles. REMD-477 was originally developed at Amgen and was licensed to REMD Bio in May 2013. In the phase 1 clinical study conducted by Amgen in healthy volunteers, a single injection of REMD-477 (then known as AMG477) reduced fasting glucose levels by 10 to 15 percent for up to four weeks.

“The promising preclinical data combined with available phase 1 data from healthy volunteers using REMD-477 opens up a brand new therapeutic chapter in the field of diabetes mellitus,” said Roger Unger, M.D., Professor and Touchstone/West Distinguished Chair in Diabetes Research at University of Texas Southwestern Medical Center, and a scientific advisor to REMD Bio.

For more information about the phase 2 clinical study of REMD-477 in type 2 diabetes, including criteria for participating and enrolling centers, please visit www.clinicaltrials.gov.

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Contact: Leah Grant (leahgrant@remdbio.com )


REMD at Lyfebulb connect

September 29, 2015 

New York, NY - REMD Biotherapuetics, Inc,. was honored to co-host a diabetes focused Lyfebulb Connect event this past week at Le Colonial in New York City. Lyfebulb is a New York-based social, patient empowerment platform with a mission to connect people, inspire change, and impact lives. Lyfebulb Connect events touch on different disease areas and typically include a brief presentation from an expert in the field as well as testimonials from patients to discuss their personal experiences with the disease. The REMD team was thrilled to partner with such a dedicated organization and to have an opportunity to reveal their findings to such an engaged audience.  

REMD CEO, Dr. Hai Yan, made an invigorating and exciting presentation regarding the company’s significant progress in diabetes research. Accompanying Dr. Yan were several members of his team, including Jim Zhiqing Shi, VP for Clinical Development, Jingang Wang, Senior Advisor, and Tom Tang, Clinical Advisor. Dr. Yan shared REMD’s work and discussed the current Phase 2 clinical development of REMD 477, an antibody targeting the glucagon receptor with the potential to improve glucose control in persons living with Type 1 and Type 2 diabetes. Coincidentally, the first patient in REMD Bio's clinical trial was dosed just two days before this Lyfebulb Connect event.  

A senior medical internist, Dr. Zachary Bloomgarden, also presented at the event on the current status and future prospect of diabetes therapies, and praised REMD’s promising therapeutic candidate drug.

REMD looks forward to continuing a fruitful partnership with Lyfebulb.



REMD BIOTHERAPEUTICS RECIEVES INVESTIGATIONAL NEW DRUG (IND) APPROVAL FOR REMD-477

September 25, 2015 

Camarillo, CA - REMD Biotherapeutics is pleased to announce that the FDA has granted Investigational New Drug (IND) status to REMD-477, their flagship drug for diabetes mellitus. The monoclonal antibody specifically targets and blocks the glucagon receptor, corrects hyperglycemia by reducing hepatic glucose output, and represents a promising new class of antidiabetic therapeutics with no risk of hypoglycemia. This drug will greatly alter the course of diabetes treatment and improve the quality of life for an ever-growing patient population.

REMD-477’s long journey
Originally one of Amgen’s shelved projects, AMG-477 found new life when REMD in-licensed the drug on May 13, 2013. It was subsequently renamed REMD-477 and the REMD team continued research where Amgen had left off. REMD-477 was once placed on a full clinical hold when an initial Amgen study found pancreatic fibrosis in some older male rats. The REMD team successfully convinced the FDA that this observation was not causally related to REMD-477. On October 20, 2013, the FDA lifted the hold, agreeing that “the pancreatic fibrotic lesions…are spontaneous, age-related lesions,” and thus were not a clinical safety concern. 

REMD’s ensuing findings were so meaningful, that they published their first paper on Type 1 Diabetes Mellitus in the Proceedings of the National Academy of Sciences (PNAS) on February 24, 2015. The paper showed significant evidence of hyperglycemia correction, several metabolic marker improvements, and restoration of normal HbA1c levels, after treatment using REMD-477 or its analogues in a number of type 1 diabetic models in mice. Clinical trials have already begun in type II diabetic patients at three sites in California, Texas, and Florida.

A well-deserved celebration
To commemorate this pivotal achievement, REMD hosted a dinner party on September 23, 2015 for employees, consultants, collaborators, friends, and family at the Westlake Village Inn in Thousand Oaks, California,. Hai Yan, President and CEO, expressed his gratitude saying: “we have worked tirelessly to reach this milestone and could not have accomplished this feat without [everyone’s] support.” Keynote speakers included VP of Clinical Development - Jim Shi, Chief Scientific Officer - Tom Boone, and Director of Quality & Regulatory Affairs - Jan Fang.  

Around 90 guests enjoyed a Pan-Asian & American dinner and a prize raffle for dinnerware sets & bottles of wine. REMD was also proud to hand out “This is my first REMD T-shirt!” shirts to all guests.



REMD WELCOMES VISITORS AND POTENTIAL PARTNERS

December 3, 2013 

The delegation highly appraised the achievements REMD had made and prospects REMD has in drug research and development. REMD also chaired a local investment fair for Suzhou Industrial Zone. 


REMD CEO participates in China Pharmaceutical Managers Week

November 22, 2013 

Dr. Yan was invited to participate in 2013 China Pharmaceutical Managers Week and the E drug Managers' fifth anniversary celebration themed events. He gave his presentation on "G protein-coupled receptor antibody drugs development" and received an overwhelming response. After the presentation, Dr. Yan met with a number of pharmaceutical companies to discuss business opportunities. 




REMD Welcomes visitors and potential partners FROM LIZHU

May 18, 2013

Mr. Desheng Tao, Vice President of China Lizhu Pharmaceutical Group (Zhuhai), together with Dr. Daotian Fu, visited REMD corporate headquarters. Dr. Yan introduced to the guests REMD's drug development history, progress and achievements. Mr. Tao and Dr. Fu expressed appreciation for the rapid development, while discussing bilateral cooperation in new drug development.

REMD & AMGEN SIGN COLLABORATIVE CONTRACT

May 13, 2013

REMD licensed AMG477 from AMGEN for research and clinical development. Dr. Yan of REMD and Dr. Dere of AMGEN, signed the contract in San Francisco with Mr. Anshun Wang, Mayor of Beijing, as witness. Beijing delegates met with REMD representatives, encouraging REMD to invest in China and promised to fully support the company. They look to REMD to be the leader in innovative product development for the Chinese market.