Halogenated Insulin: a fast-acting, ultra stable analog.

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$392,091.00
Award Year:
2010
Program:
SBIR
Phase:
Phase I
Contract:
1R43DK088506-01
Agency Tracking Number:
DK088506
Solicitation Year:
n/a
Solicitation Topic Code:
NIDDK
Solicitation Number:
n/a
Small Business Information
THERMALIN DIABETES, LLC
THERMALIN DIABETES, LLC, 11000 CEDAR AVENUE SUITE 100, CLEVELAND, OH, 44106
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
802601570
Principal Investigator:
BRUCE FRANK
() -
Business Contact:
DAVID TISCHLER
() -
david@venzyme.com
Research Institution:
n/a
Abstract
DESCRIPTION (provided by applicant): A Phase 1 SBIR program of pre-clinical development is proposed focusing on a novel rapid-acting insulin analog for the treatment of diabetes mellitus. Designated Insulin-Cl, our product is a derivative of insulin lispro (the active component of HumalogTM) containing a single chloro-substitution within the aromatic ring of a conserved phenylalanine in the B-chain (PheB24). Insulin-Cl retains the interchange of residues B28 and B29 (substitutions ProB28 .Lys and LysB29.Pro ) that confers upon HumalogTM its rapid absorption following subcutaneous injection. Insulin-Cl offers to patients the potential advantages of (i) greater shelf life and stability to degradation at temperatures above room temperature; and (ii) possible for mulation as a zinc-free solution to provide ultra- rapid absorption. Current meal-time insulin analogs such as HumalogTM and NovalogTM are less stable than human insulin and must be formulated as zinc insulin hexamers; as a consequence, absorption is in pr inciple not as rapid as could be provided by a zinc-free formulation. Ultra-rapid absorption of Insulin-Cl may offer added patient convenience and also enhanced safety in closed-loop smart pumps coupled to glucose sensors. We seek to test candidate formu lations of Insulin-Cl and to assess its in vivo potency and pharmacokinetics in animal models. Insulin-Cl was invented at Case Western Reserve University and is being developed under license to Thermalin Diabetes, Inc. The principal investigator, who bring s to this application four decades of experience in pharmacetical studies of insulin formulations, was co-inventor of insulin lispro. PUBLIC HEALTH RELEVANCE: Diabetes is an increasingly prevalent disease in the developed and developing worlds; pati ents seek greater convenience, improved glycemic control, and fewer adverse side-effects, all of which result in greater compliance and lower healthcare costs. This project will complete pre- clinical development of Insulin-Cl, a potentially ultra-stable a nd ultra-rapid acting insulin analog which could conveniently be stored without refrigeration and taken closer to meal time and could cause less post-meal glucose deficiency.

* information listed above is at the time of submission.

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