April 20, 2024

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[THE INVESTOR] HanAll Biopharma, a subsidiary of Daewoong Pharmaceutical, said on Oct. 29 it plans to begin phase 3 clinical trials for its anti-TNF ophthalmic solution HM036 in 2019 after completing its study on 150 patients with dry eye syndrome.

The Seoul-based biotech presented the results of phase 2 clinical trials in the US, which ended early this year, at the Ophthalmology Innovation Summit, American Academy of Ophthalmology 2018, held on Oct. 26. 

“We presented the outstanding safety and efficacy results of HL036 in inhibiting corneal scarring and mitigating the symptoms of dry eye at the event,” Medical Director Edward Bernton said in a statement.

He said the company will promote the clinical results to investors and ophthalmic pharma companies.

HL036 is a TNF reception fragment which has been molecularly engineered to enhance tissue penetration efficiency and TNF-neutralizing potency for the best topical anti-TNF peptide. HanAll has developed the HL036 eye drops for treatment of dry eye disease and other inflammatory ocular diseases.

The company aims to tackle the global dry eye therapy market worth 3.8 trillion won (US$3.34 billion), including the 2.7 trillion won-worth market in the US, with the drug candidate.

HanAll said unmet demand in the US with over 30 million patients is high as there are only two dry eye treatments approved by the Food and Drug Administration.

The number of patients who suffer from the condition is expected to increase due to heavy usage of smartphones and laser eye surgeries, leading the market to reach 7 trillion won by 2027, it said.

Separately, HL036 will undergo phase 2 clinical trials in China as Shanghai-based Harbour BioMed received approval from the country’s health regulator on Oct. 1. In 2017, HanAll sold rights to HL036 and the anti-FcRn monoclonal antibody HL161 to the firm to develop, manufacture and commercialize in mainland China.

By Park Han-na (hnpark@heraldcorp.com)