By Chris Wack

4D Molecular Therapeutics Inc. said the U.S. Food and Drug Administration has cleared the investigational new-drug application for 4D-150 for wet age-related macular degeneration.

The company said the active IND enables the initiation of 4D-150 Phase 1/2 clinical trial sites, which is expected before year-end.

4D Molecular Therapeutics also said the FDA has cleared the IND application for 4D-710 for the treatment of patients with cystic fibrosis. This active IND enables the initiation of 4D-710 Phase 1/2 clinical study sites, which is also expected before the end of the year, the company said.

The Phase 1/2 clinical trial for 4D-150 is a dose-escalation and randomized, controlled, masked expansion trial, expected to enroll 60 adults with wet AMD. The primary endpoints of the study are safety and tolerability, the company said.

Secondary endpoints include the number of supplemental aflibercept injections received, and change from baseline in best corrected visual acuity over time, the company said.

The Phase 1/2 clinical trial for 4D-710 is dose-expansion trial of 4D-710 in patients with cystic fibrosis who are ineligible for cystic fibrosis transmembrane conductance regulator, or CFTR, modulator therapy or who have discontinued therapy due to adverse effects. The primary endpoint of the study is safety and tolerability, the company said.

As a result of the IND clearance for 4D-710, the Cystic Fibrosis Foundation will buy 126,000 shares of 4D common stock for proceeds of $4 million, in accordance with the terms of the company's collaboration with the foundation. The proceeds of the CF Foundation's equity investment will be used to further support development of 4D-710, the company said.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

10-06-21 0827ET