Reaching a milestone that management says will pave the way to the company's "first significant revenue channel," Immune Therapeutics, Inc. (OTCQB:IMUN) said Monday morning that it received approval for its HIV treatment called Lodonal from NAFDAC (National Agency for Food and Drug Administration and Control) in Nigeria. Lodonal is an opiate antagonist shown to act as an immune modulator that works by rebalancing the immune system. The approval labels Londonal as a one-day immune system regulator for the management of HIV/AIDS.
Immune Therapeutics is looking to penetrate an HIV/AIDS market consisting of 3.2 percent of the 180 million Nigerians living with HIV/AIDS, representing the second largest HIV/AIDS population globally.
The approval was supported by a 90-day bridging study in Nigeria that showed Londonal-treated patients to experience a 44% increase in CD4, a type of white blood cell that fights infections, compared to only 11% for patients receiving standard of care. Other studies have further shown patient improvements, including reduction in opportunistic infections.
Immune Therapeutics said this morning it expects additional regulatory approvals from Kenya, Senegal and Cote d'Ivoire in the fourth quarter this year or early in 2018. Based upon the approval in Nigeria and other anticipated approvals, the company believes it is on track to achieve profitability in 2017.
Investors are buying on the news, with shares up 17.3% at 7.3 cents after closing at 6.2 cents per share on Friday. With 304.14 million shares outstanding, according to QuoteMedia data, the rise in value gives IMUC a market capitalization of $22.3 million.
