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- smart insulin (MK-2640) / Merck (MSD)
KEYNOTE: The Risks and Rewards of Bootstrapping a Biotechnology Company (In-person; Gravier A Ballroom (New Orleans Marriott Warehouse Arts District)) - Mar 12, 2024 - Abstract #ACSSp2024ACS_Sp_2569;
This firsthand account delves into a CEO's journey employing these principles at SmartCells, Inc., a company built on MIT-licensed technology striving to pioneer the world's first glucose-responsive insulin for diabetes...Emphasis is placed on distinguishing frugality from miserliness, emphasizing that a company's fate hinges on judicious spending for maximum impact. The talk also underscores the significance of pivoting and highlights the resilience achieved during macro-environmental downturns, exemplified by SmartCells weathering the 2008-2009 financial crisis and Akston's adaptability in the post-Covid landscape.
- | smart insulin (MK-2640) / Merck (MSD)
Journal: A model-informed drug discovery and development (MID3) strategy for the novel glucose-responsive insulin MK-2640 enabled rapid decision making. (Pubmed Central) - Feb 17, 2021
The development and application of in-silico modeling approaches by leveraging substantial published clinical insulin PKPD data and emerging (pre-)clinical data enabled rapid quantitative decision-making. Learnings can be applied to define PKPD properties of novel insulins that could become therapeutically meaningful for diabetic patients.
- | smart insulin (MK-2640) / Merck (MSD)
Journal: Ultrahigh performance liquid chromatography methods facilitate the development of glucose-responsive insulin therapeutics. (Pubmed Central) - Feb 19, 2020
The high specificity of the method allowed the separation of the degradation products from main peak, thus makes it suitable for stability monitoring. The major impurities in the DS were characterized by two-dimensional liquid chromatography-mass spectrometry (2D-LC-MS).
- || smart insulin (MK-2640) / Merck (MSD)
Clinical, Journal: Clinical Evaluation of MK-2640: An Insulin Analog with Glucose-Responsive Properties. (Pubmed Central) - Nov 19, 2019
In a randomized, 2-period crossover trial in 16 subjects with type 1 diabetes mellitus to evaluate glucose-responsiveness of i.v. administered MK-2640, we were unable to demonstrate a glucose-dependent change in MK-2640 clearance, though a significant glucose-dependent augmentation of glucose infusion rate was observed. These PK and PD data provide crucial insights into next steps for developing an insulin saccharide conjugate as a clinically effective glucose-responsive insulin analog.
- ||| smart insulin (MK-2640) / Merck (MSD)
Trial completion: A Three-part Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Participants (Part I) and Participants With Type 1 Diabetes Mellitus (Parts II and III) (MK-2640-001) (clinicaltrials.gov) - Aug 19, 2016
P1, N=74, Completed, Sponsor: Merck Sharp & Dohme Corp.
These PK and PD data provide crucial insights into next steps for developing an insulin saccharide conjugate as a clinically effective glucose-responsive insulin analog. Active, not recruiting --> Completed
- || smart insulin (MK-2640) / Merck (MSD)
Enrollment closed: A Three-part Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Participants (Part I) and Participants With Type 1 Diabetes Mellitus (Parts II and III) (MK-2640-001) (clinicaltrials.gov) - May 13, 2016
P1, N=74, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- ||| smart insulin (MK-2640) / Merck (MSD)
Enrollment open, Enrollment change, Trial primary completion date: A Three-part Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Participants (Part I) and Participants With Type 1 Diabetes Mellitus (Parts II and III) (MK-2640-001) (clinicaltrials.gov) - Oct 1, 2015
P1, N=74, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Recruiting --> Active, not recruiting Active, not recruiting --> Recruiting | N=58 --> 74 | Trial primary completion date: Jun 2015 --> Dec 2015
- || smart insulin (MK-2640) / Merck (MSD)
Enrollment closed: A Three-part Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Participants (Part I) and Participants With Type 1 Diabetes Mellitus (Parts II and III) (MK-2640-001) (clinicaltrials.gov) - Jun 30, 2015
P1, N=58, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Active, not recruiting --> Recruiting | N=58 --> 74 | Trial primary completion date: Jun 2015 --> Dec 2015 Recruiting --> Active, not recruiting
- ||| smart insulin (MK-2640) / Merck (MSD)
Enrollment open, Enrollment change: A Three-part Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Participants (Part I) and Participants With Type 1 Diabetes Mellitus (Parts II and III) (MK-2640-001) (clinicaltrials.gov) - Dec 6, 2014
P1, N=58, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting | N=40 --> 58
- | smart insulin (MK-2640) / Merck (MSD)
New P1 trial: A Three-part Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Participants (Part I) and Participants With Type 1 Diabetes Mellitus (Parts II and III) (MK-2640-001) (clinicaltrials.gov) - Oct 22, 2014
P1, N=40, Not yet recruiting, Sponsor: Merck Sharp & Dohme Corp.