Conjuchem put out a press release a few moments ago that indicated that the company is abandoning its GLP-1 daily product- dilutent didn't work and the GI/drop out problems were severe with this one (we wrote about in a DCU last year for anyone who you'd like to see history who hasn't). While the prospects for the product weren't bright based on the side effect profile and high number of drop-outs, this appears to confirm there is no development potential for DAC GLP-1.
As such, Conjuchem is moving forward only with once-weekly GLP-1 compound, which will enter clinic in first half 2006 - so would assume anything of note would be done post 2010. We aren't sure why this is being called a phase 1/2 program.
The company has been discussing potential big pharma partnerships for some time; it sounds like the current hope is to have a partnership in place by mid-2006, when initial once-weekly data will be announced.
Recall that Novo had announced a delay of its own GLP-1 product last year - this reinforces for us Amylin's strength in the area with Byetta and LAR as well as the complexity in making these products. Even in the best case scenario, given this morning's setbacks, it would seem that the company couldn't have a compound marketed before 2011 or beyond.
MONTREAL, Sept. 30 - ConjuChem Inc. (TSX: CJC) today announced that
further development activities for its DAC(TM):GLP-1 compound have been put on
hold pending completion of the Phase I study in patients with
PC-DAC(TM):Exendin-4 in the first half of 2006.
The Phase 1 single dose trial in patients with diluent (D23) improved the
tolerability profile of the in vivo DAC(TM):GLP-1 compound. However, the
three-month D23 toxicity studies in animals failed to provide sufficient
safety margins to advance D23 as a diluent into chronic dosing regimes.
Additionally, the pharmacokinetic and pharmacodynamic profile of
DAC(TM): GLP-1, using diluent D23 did not lend itself to once weekly dosing.
"ConjuChem's goal is to develop a best in class GLP-1 analogue," said
Dr. Jean Paul Castaigne, ConjuChem's COO. "The data generated to date with
PC-DAC(TM):Exendin-4 program indicates that this compound has the strongest
potential to emerge as the leader in the GLP-1 class of drug therapies. Proof
of concept data in patients is expected in the first half of 2006."
PC-DAC(TM):Exendin-4 will be administered to Type 2 diabetic patients in
a Phase 1/2 clinical program starting in Q1 2006. To date, the pre-clinical
data has been very encouraging, demonstrating a significantly extended
half-life of 30 fold relative to native exendin-4. This longer half-life
resulted in a longer duration of therapeutic activity. Full glucose control
was obtained for more than a week after a single injection of
PC-DAC(TM):Exendin-4 in ZDF rats (ZDF rats are obese rats with Type 2
diabetes). Finally, a significantly better tolerability profile was observed
compared to exendin-4 in two independent rat models, which assessed GI
tolerance and nausea. PC-DAC(TM):Exendin-4 is expected to be stable at room
temperature, thus being highly convenient for patients.
Developed to treat Type 2 diabetes, exendin-4 is a close analogue to
GLP-1, the human body's most potent insulinotropic hormone. It has been shown
to normalize blood glucose levels by a) stimulating insulin secretion and
lowering glucagons secretion in a glucose-dependent manner; b) delaying
gastric emptying; c) induces Beta cell proliferation (demonstrated only in
animals to date); d) restores Beta cell sensitivity to glucose; and
e) increases peripheral sensitivity to insulin . Moreover, it appears to have
a very attractive safety profile, with a low probability of inducing
ConjuChem, developers of next generation medicines from therapeutic
peptides, is creating long-acting compounds based on bioconjugation platform
technologies. When applied to peptides, the Company's systemic DAC(TM)
Technologies enable the creation of new drugs with significantly enhanced
therapeutic properties as compared to the original peptide. The Company is
developing compounds to treat various disorders including diabetes, human
growth deficiencies, HIV/AIDS, and congestive heart failure.
Detailed descriptions of the Company can be viewed on the Company's