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Gilead (GILD) Reports Positive Top-Line Data on HIV Candidate

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Gilead Sciences, Inc. (GILD - Free Report) announced positive top-line results from the phase II/III CAPELLA study on lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor.

Lenacapavir is being developed as a component of a long-acting regimen in combination with other antiretroviral agents for the treatment of HIV-1 infection.

The study is evaluating the candidate in heavily treatment-experienced people with multidrug-resistant HIV-1 infection. 

In the study, 36 adults with multi-class HIV drug resistance and a detectable viral load while on a failing regimen were randomized 2:1 to receive oral lenacapavir or placebo for 14 days, in addition to continuing their failing regimen (functional monotherapy).

The results showed that a statistically significant greater proportion of participants receiving lenacapavir met the primary endpoint of a viral load reduction of at least 0.5 log10 copies/mL from baseline compared with those receiving placebo at the end of the 14-day functional monotherapy period (88% vs. 17%). Additionally, the lenacapavir group achieved a statistically significant greater mean change in viral load versus the placebo group.

The successful study results support further study of lenacapavir in patients with multidrug resistant HIV-1 Infection who are failing current treatment regimen.

The successful results of the study increase the likelihood of a potential approval of the candidate.

A potential approval will make lenacapavir the first HIV capsid inhibitor available for the treatment of HIV-1 infection. In May 2019, the FDA granted a Breakthrough Therapy designation to the development of lenacapavir for the same indication.

Meanwhile, the safety, efficacy and dosing of lenacapavir are being evaluated in multiple ongoing clinical studies. Earlier, the company announced the addition of a new study arm to the Women’s HIV Prevention Study evaluating the use of lenacapavir as an injectable PrEP option administered every six months.

The massive decline in sales of Gilead’s HCV franchise has propelled it to focus on its HIV franchise, Yescarta and other newer avenues. The rapid adoption of Biktarvy maintains momentum in the HIV space amid stiff competition from the likes of GlaxoSmithKline (GSK - Free Report) .

However, the company is looking to diversify its portfolio, given the increasing competition in the HIV space. The company’s efforts to strengthen its oncology franchise are encouraging as well.

Gilead’s stock has lost 7.8% in the year so far compared with the industry's decline of 2.6%.

 

Other players in this space include Janssen Pharmaceuticals, a unit of Johnson & Johnson (JNJ - Free Report) .

Gilead currently carries a Zacks Rank #3 (Hold). A better-ranked player in the biotech space is Halozyme Therapeutics, Inc. (HALO - Free Report) , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Halozyme’s earnings estimates are up 14 cents in the past 30 days for 2020.

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