HONG KONG – South Korean biotech firm Genexine Inc. (KOSDAQ:095700) recently released interim results for its second clinical trial of GX-H9, to treat growth hormone (GH) deficiency.

"So far, we have both weekly and twice-monthly long-acting growth hormone for adult growth hormone-deficient patients. This is exciting for us as we are the most advanced among the adult GH-deficient trials compared to our peers, especially with longer than once-a-week dosing," Michael Keyoung, CEO and president of Genexine, told BioWorld Today.

"We are certainly equivalent to daily GH in safety profile, as our trial was designed to be noninferior to daily GH. So far, in our adult [AGHD] and pediatric [PGHD] trials, we have had no serious adverse events and only mild adverse events as expected with daily GH," Keyoung added. "We are also happy to report that we had no anti-drug antibodies so far detected."

The company's main asset, GX-H9 is targeted for the treatment AGHD and PGHD.

A well-known pediatric endocrinology consultant, Ron Rosenfeld, professor emeritus of pediatrics at both Stanford University and Oregon Health and Science University, commented that GX-H9 would be safe because it would only stay in the system for several days before being cleared away.

Genexine said the market size for AGHD and PGHD is currently $4 billion globally and is expected to grow to $5 billion by 2018 for current daily human growth hormone products.

Human growth hormone is a polypeptide hormone produced by the pituitary gland located in the lower part of the brain. The hormone is primarily responsible for increasing height. Lack of growth hormone can lead to dwarfism, delay in sexual maturity or growth delay.

Genexine is co-developing GX-H9 with another Korean company, Handok Pharmaceuticals Co. Ltd., one of the companies selected by the Korean Drug Development Fund Program.

Genexine signed a contract for the development right of GX-H9 with Tasgen and is preparing to enter clinical trials in China. Tasgen is China's 13th largest biotherapeutics joint venture, established by Genexine, Tasly Pharmaceutical Group Co. Ltd. (SH:600535) and I-bridge Capital in October 2015. Three of Genexine's compounds – GX-H9, GX-C6 and GX-G3 – have been licensed out to the Chinese pharmaceutical firm.

GX-C6 is a long-acting GLP-1 therapeutic for diabetes, while GX-G3 targets neutropenia.

"The current market size of daily first-generation GH is above $4 billion and this continues to grow annually despite going off patent since the first GH approval more than 30 years ago," said Keyoung.

The market is expected to grow even more once long-acting, second-generation growth hormones are introduced in a few years.

One of the largest markets outside the U.S., Japan and Europe is China. With its growing middle class and increasing purchasing power, many see greater adoption and uptake of GH, especially as treatments become more convenient for increased compliance and efficacy.

"We are excited to share our data in China in partnership with Tasgen to educate endocrinologists and recruit potential clinical trial investigators in China who can run our trials and also eventually prescribe our long-acting GH," said Keyoung.

Currently, the company is conducting seven trials with six phase II trials and one phase I trial, domestically and globally.

Two phase II trials are for the human papillomavirus (HPV) therapeutic vaccine for cervical intraepithelial neoplasia, also known as cervical dysplasia, which is a pre-cancer to HPV cervical cancer. The trials are being conduced in Europe and Korea. The other two phase II trials are for growth hormones, which are conduced in Europe and Korea as well.

"We are in [a] phase IIb trial for long acting EPO in Korea as well as phase II for long-acting G-CSF in Europe/Asia. We recently started phase I trial with long-acting IL-7, which acts as T-cell booster for immune oncology setting in Korea," Keyoung said. "We have two more phase I trials that will start likely by year-end. Next year, we will start even more trials, including a U.S. trial," specifically a phase Ib/IIa study in cancer.

Genexine, founded in 1999, started as a bio venture capital firm. Since 2013, the company has been focusing on developing new drugs and currently leads the development of long-acting growth hormone.