Apellis’ temporary pose on APL-2 for Geographic Atrophy could threaten its first-to-market position, says GlobalData

Following a voluntary pose in dosing patients with geographic atrophy (GA) in Apellis’ Phase III GA program, due to observed cases of non-infectious inflammation in patients treated with APL-2 last month,

Edit Kovalcsik, Managing Pharma Analyst at GlobalData, a leading data and analytics company, offers her view on the foreseeable competition of two companies for share of the GA market:

“Currently there are no effective treatments for patients suffering from GA as a consequence of dry age-related macular degeneration (AMD). Without exception, all pipeline drugs have failed late stage development, including Roche’s originally promising complement inhibitor, lampalizumab, leaving approximately 2.6 million people with the risk of developing severe visual impairment in the 7MM*.

“With its encouraging Phase IIa (FILLY) trial results to slow GA lesion growth, Apellis has been at the forefront of delivering the first potential complement inhibitor into market in the hope of preserving GA patients’ vision. During the FILLY trial there were no endophthalmitis cases, therefore the company believes that the cause of inflammation experienced in the Phase III GA trial is likely to be due to a single lot of APL-2. Apellis aims to resume dosing by the end of 2018 with no delay to its projected enrolment timeline.

“According to a press release by Shuan Sim, Reporter of BioPharm Insight at GlobalData; however, two investigators at the American Academy of Ophthalmology’s annual meeting in Chicago suggested that, although it is not impossible, the company is unlikely to resume its Phase III GA trial by the end of 2018, due to the time consuming process to present all the required confirmatory documents to the FDA. Should the trial not resume by the end of 2018, an early 2019 start could delay the original projected enrolment timeline.

“In contrast, Apellis’ biggest challenger, Ophthotech, announced progress in development of its complement inhibitor, Zimura (avacincaptad pegol), which had completed patient recruitment for its Phase 2b trial in GA earlier in October with plans to report top-line data from its Phase 2b GA program by the end of 2019.

“Delays in APL-2 development could mean more competition with Ophthotec’s Zimura and it could impact its share of the potentially lucrative GA market, which is expected to reach about $3bn in the 7MM by 2026, according to GlobalData.”

* 7MM: seven major markets – US, France, Germany, Italy, Spain, UK and Japan.

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