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SPARC gains after positive top-line results from phase 3 trial for investigational drug

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SPARC rose 1.29% to Rs 171.55 after the company announced positive top-line results from pivotal phase 3 clinical trial of its investigational drug for treating inflammation and pain associated with ocular surgery.

The company's investigational drug, SDN-037, is a novel, twice-a-day, clear, micellar formulation of difluprednate. The phase 3 trial of SDN-037 met its pre-specified primary and secondary objectives, demonstrating that SDN-037 is superior to its vehicle. The objective of the trial was to assess the efficacy and safety of SDN-037 in clearing the inflammation and pain.

To that end, the primary efficacy measure was the proportion of subjects with an anterior chamber cell (ACC) grade of zero (0) on Day 15 (zero inflammation). A statistically significant proportion of patients treated with SDN-037 achieved an ACC grade of 0 versus vehicle with p-values <0.0001 in the Intent-To-Treat population.

A key secondary endpoint was the proportion of subjects with a visual analog scale (VAS) pain score of zero (0) at Day 15, and this was also statistically significant in patients treated with SDN-037 compared to vehicle. SDN-037 was generally well-tolerated in this study with adverse events consistent with the known safety profile of difluprednate.

The announcement was made before trading hours today, 14 October 2020. Shares of SPARC fell 3.17% in the past three trading sessions to settle at Rs 169.35 yesterday, 13 October 2020, from its close of Rs 174.90 on 8 October 2020.

SPARC recorded a net profit of Rs 56.69 crore in Q1 FY21 as compared to a net loss of Rs 94.19 crore in Q1 FY20. Net sales in the first quarter surged to Rs 185.45 crore from Rs 17.32 crore reported in the same period last year.

SPARC is engaged in research and experimental development on natural sciences and engineering. The company operates through pharmaceuticals research and development segment.

Currently, the stock was trading 18.58% below its 52-week high of Rs 210.70 hit on 28 January 2020. The scrip has galloped 111.79% from its 52-week low of Rs 81 hit on 25 March 2020.

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

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First Published: Wed, October 14 2020. 10:56 IST