Biocon Ltd on Tuesday said its potential insulin pill did not fully meet the primary goal of lowering blood sugar levels to the desired level, according to a clinical study just completed in the country.

The data obtained from trials on 264 patients at multiple centres was being assessed further, the company said in a release.

The drug, tentatively called IN-105, however proved safe, or without serious side-effects, and did not increase the patients' weight (as generally happens with insulin use), it said.

However, Ms Kiran Mazumdar-Shaw, Biocon's Chairman and Managing Director, called the outcome “encouraging” for going ahead with collaborative global development with a global partner. Biocon would start discussions to find a partner, she was cited in a release.

Company officials were not available to clarify and the spokeswoman said this was its ‘silent period' before third-quarter results are announced on January 20.

Biocon's share price on the BSE fell by Rs 2.40 to Rs 387.

Dr Harish Iyer, Biocon's Vice-President, R&D, was quoted as saying, “These results build on the now considerable body of data generated for IN-105, strengthening our conviction of the promise of oral insulin. The lessons learned here will be fully utilised in designing future studies for the global clinical development programme.”

Sometime last year, Biocon undertook what is called a “double-blind placebo-controlled trial.”

Patients poorly controlled on metformin, an established anti-diabetic drug, were randomised to receive either IN-105 or placebo.

The patients in both arms of the study continued with metformin as background therapy.

It said some subsets of patients under study showed lower glucose levels as desired; and some others may have made some behavioural changes that affected the trial outcome.

The company said, “Initial data analyses show that IN-105 did not meet its primary end point of lowering HbA1c levels by 0.7 per cent compared to placebo, although an unexpectedly high placebo response was also observed.

Post hoc analysis of self-monitored blood glucose levels in the IN-105 arm and the placebo arm indicated large reductions in pre-meal glucose levels in the placebo arm, strongly suggestive of behavioural modification and which might have confounded the primary endpoint outcome.” (HbA1c is a current test for diabetes and is based on glucose in haemoglobin.)

It said, “Additionally, in further post hoc analyses, significant reductions in HbA1c levels compared to placebo, and HbA1c reductions of up to 0.8 per cent were observed in the IN-105 arm of several subsets of the studied patient population. Further assessment of the data is on-going.”

Related Topics
comment COMMENT NOW