Besseres Humalog???
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Eröffnet am: | 14.09.14 11:38 | von: ellogo2 | Anzahl Beiträge: | 13 |
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Hintergrund: Im April 2014 zeigte ADOCIA erste Resultate von U100, welche einen schnelleren Wirkeintritt und eine kürzerer Wirkdauer als HUMALOG aufzeigten. Mittlerweile wurde eine Dosis-Wirkungs-Studie bei T1DM gestartet. ELI LILLY entwickelt ebenfalls eine konzentrierte Version (U200) des HUMALOG, für Patienten mit hohen Dosierungen, im KwikPen. Vor kurzem hat allerdings die FDA einen „complete response letter“ an ELI LILLY geschickt, die diesen aber noch in H2 2014 beantworten wollen.
Hintergrund: ADOCIA konnte schon zeigen, dass HINSBET einen vergleichbaren Wirkeintritt und Sicherheit wie NOVORAPID® hat. Seitdem arbeitet ADOCIA daran die Formulierung von HINSBET zu optimieren. Das Produkt soll die Vorteile der schnellen Wirkung der Insulinanaloga mit dem Preis der Humaninsuline kombinieren und für die Märkte und Länder mit einem geringen Einkommen vorgesehen sein.
Concentrated formulation of insulin lispro included in the collaboration
Under the terms of the agreement, Eli Lilly is responsible for future development, manufacturing, and commercialisation of an ultrarapid-acting formulation of Humalog (insulin lispro), BioChaperone Lispro. Adocia will receive a total upfront fee of USD 50 million with the potential for future payments of up to USD 520 million in development, regulatory and sales milestones.
The companies have previously collaborated on developing ultrarapid-acting insulins but the collaboration was terminated in July 2013 for undisclosed reasons. Since then, Adocia has continued development of a variety of insulin formulations including ultrarapid-acting insulin lispro. Eli Lilly is currently initiating two phase 1 trials comparing 1) a novel insulin, LY900014 new formulations of lispro with Humalog. One of these trials might be evaluating BioChaperone Lispro.
BioChaperone Lispro has demonstrated faster onset of action and shorter duration than Humalog
A PK/PD study in T1DM (n=36) demonstrated 30% faster onset of action, a 70% increase in glucose lowering effect during the first hour and 20% increase during the first two hours vs Humalog. Late glucose lowering effect was significantly lower with BioChaperone Lispro than with Humalog. Further, Adocia has shown proportional dose-exposure and linear dose-response with BioChaperone Lispro.
Comment: Adocia's formulations comprise a reversible complex of insulin and a polysaccharide polymer based on the company's BioChaperone technology.
A concentrated formulation of BioChaperone Lispro is also part of the agreement
Comment: Adocia has concentrated a U300 lispro formulation in preclinical development and has demonstrated faster onset of action vs Humalog U100. BioChaperone Lispro U300 is planned to enter clinical testing in H1 2015. Eli Lilly has also developed a concentrated version of insulin lispro, Humalog U200 KwikPen. The product was recently approved in EU, 24 April 2014) but intends to resubmit to the FDA in Q4 2014, most likely pending completion of another bioequivalence study for two lispro formulations.
The phase 1b crossover trial will evaluate postprandial glucose control with Acodia’s ultrarapid BioChaperone Lispro vs Humalog following a single administration at the start of a standardised meal in T1DM patients (n=36).
Primary endpoint is blood glucose AUC(0-2 h). Secondary endpoints include PK and PD parameters from 0-30 min up to 8 hours.
The trial is sponsored by Adocia.
Comment: This study is the first trial to be conducted under Adocia’s newly established collaboration with Eli Lilly. In December 2014, the two companies re-entered an alliance
A concentrated formulation of BioChaperone Lispro is also part of the new agreement. Eli Lilly is additionally conducting two phase 1 trials comparing 1) a novel insulin, LY900014
might be some particular concentration of BC Lispro ...U300 or U500 ?
what's ramarkabke is that Ly900014 clinical trials (3 trials so far) are launched pretty close to the BC Lispro trials planning...
last Ly900014 trial was launched late december and lication is Singapore...
thanks fir sharing any clue about that peculiar product Ly900014
:-)
Ich bin heute eingestiegen mit dem Ziel 55€ nächsten Monat.
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